RWANDA STANDARD DRS 392-2 - Rwanda Standards Board

RWANDA DRS
STANDARD
 392-2

 Second edition

 2021-mm-dd

Skin applied mosquito repellents —

Specification —

Part 2:

Sprays and roll-ons

ICS 65.100

 Reference number

 DRS 392-2: 2021

 © RSB 2021

DRS 392-2: 2021

 In order to match with technological development and to keep continuous progress in industries,
 standards are subject to periodic review. Users shall ascertain that they are in possession of the latest
 edition

 © RSB 2021

 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized
 in any form or by any means, electronic or mechanical, including photocopying and microfilm, without
 prior written permission from RSB.

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 Rwanda Standards Board

 P.O Box 7099 Kigali-Rwanda

 KK 15 Rd, 49

 Tel. +250 788303492

 Toll Free: 3250

 E-mail: info@rsb.gov.rw

 Website: www.rsb.gov.rw

 ePortal: www.portal.rsb.gov.rw

©RSB 2021 - All rights reserved ii

DRS 392-2: 2021

Contents Page

Foreword ............................................................................................................................................................ iv

1 Scope ...................................................................................................................................................... 1

2 Normative references ............................................................................................................................ 1

3 Terms and definitions ........................................................................................................................... 1

4 Requirements ......................................................................................................................................... 3
4.1 General requirements ........................................................................................................................... 3
4.2 Active ingredients and synergists ....................................................................................................... 3
4.2.1 Natural repellents .................................................................................................................................. 3
4.2.2 Synthetic repellents .............................................................................................................................. 3
4.2.3 Synergist content .................................................................................................................................. 4
4.3 Specific requirements ........................................................................................................................... 4
4.4 Biological efficacy ................................................................................................................................. 4

5 Packaging and labelling........................................................................................................................ 4
5.1 Packaging ............................................................................................................................................... 4
5.2 labelling .................................................................................................................................................. 5

6 Sampling ................................................................................................................................................ 5

Annex A (informative) Some common essential oils in natural repellents that may be hazardous ......... 6

Annex B (informative) Plant-based insect repellents: a review of their efficacy, development and
 testing ..................................................................................................................................................... 8

Annex C (informative) Active ingredients for synthetic repellents ............................................................ 16

Annex D (normative) Non-volatile matter...................................................................................................... 18
D.1 Apparatus ............................................................................................................................................. 18
D.2 Procedure ............................................................................................................................................. 18
D.3 Calculation ........................................................................................................................................... 18

iii ©RSB 2021 - All rights reserved

DRS 392-2: 2021

Foreword
Rwanda Standards are prepared by Technical Committees and approved by Rwanda Standards Board (RSB)
Board of Directors in accordance with the procedures of RSB, in compliance with Annex 3 of the WTO/TBT
agreement on the preparation, adoption and application of standards.

The main task of technical committees is to prepare national standards. Final Draft Rwanda Standards
adopted by Technical committees are ratified by members of RSB Board of Directors for publication and
gazettment as Rwanda Standards.

DRS 392-2 was prepared by Technical Committee RSB/TC 015, Pharmaceutical Products.

This second edition cancels and replaces the first edition (RS 392-2: 2018), which has been technically
revised.

DRS 392 consists of the following parts, under the general title Skin applied mosquito repellents —
Specification:

 Part 1: Lotions, creams, gels and ointments

 Part 2: Sprays and roll-ons

 Part 3: Wipes

 Part 4: Soaps

 Part 5: Bracelets, wristbands and patches

Committee membership

The following organizations were represented on the Technical Committee on Pharmaceutical Products
(RSB/TC 015) in the preparation of this standard.

AGROPY Ltd

HORIZON/SOPYRWA

IKIREZI Natural Products

Institute d’Enseignement Superieur de Ruhengeri (INES – RUHENGERI)

National Industrial Research and Development Agency (NIRDA)

National Pharmacy Council (NPC)

©RSB 2021 - All rights reserved iv

DRS 392-2: 2021

Healthcare Pharmacy

Rwanda Biomedical Center/Malaria and Other Parasitic Diseases Division (RBC/MOPDD)

Rwanda Development Board (RDB)

Rwanda Food and Drugs Authority (Rwanda FDA)

Rwanda Forensic Laboratory (RFL)

Rwanda Inspectorate, Competition and Consumer Protection Authority (RICA)

Rwanda Investigation Bureau (RIB)

Rwanda Social Security Board (RSSB)

University of Rwanda/College of Education

University of Rwanda/College of Medicine and Health Sciences (UR/CMHS)

University of Rwanda/College of Sciences and Technology (UR/CST)

Rwanda Standards Board (RSB) – Secretariat

v ©RSB 2021 - All rights reserved

DRS 392-2: 2021

Introduction

Mosquito repellents are an effective complement to bed nets in the prevention of mosquito borne diseases,
especially malaria.

Insecticides are used either for killing or controlling harmful insects. The insecticides which are applied for
repelling insects are termed as “Repellents". Mosquito is one of the most harmful insects for mankind. To
destroy them, many preparations are available on the market in various recipes like pest killer spray, soap, oil,
powder, repellent etc. Out of these, mosquito repellent is the most popular as it has germicidal and
disinfectant properties and is able to repel mosquitoes and is convenient to use.

The mosquito repellent is used for warding off mosquitoes which is the most harmful insect. Nowadays,
mosquito repellents are used for controlling mosquitoes and are becoming most preferably than other
mosquito destroyers gradually. With the rise in the standard of living, increasing urbanization and population,
the demand of mosquito repellent mat is constantly increasing particularly in tropical places. It is a convenient
method for protection against mosquitoes, so it has a tremendous market potential. Thus, there is a very good
scope for development of such units in the country.

Skin applied mosquito repellents possess the potential to target residual transmission. Entomological
evidence has shown that repellents provide personal protection against malaria. Product examples that are
commonly used include lotions, gels, creams and ointments, among others. However, many more types of
skin applied repellent products are now developed in various forms such as sprays and roll-ons, wipes, soaps
and bracelets, wristbands and patches.

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DRS 392-2: 2021

Skin applied mosquito repellents — Specification — Part 2: Sprays and
roll-ons

1 Scope

This Draft Rwanda Standard prescribes the requirements, sampling and test methods for skin applied
mosquito repellents formulated and/or prepared as sprays and roll-ons and meant to be applied directly to skin
or to clothing and/or footwear.

2 Normative references

The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.

RS EAS 846, Glossary of terms relating to the cosmetic industry

RS EAS 377 (all parts), Cosmetics and cosmetic products

RS 191, Refined pyrethrum concentrate ― Specification

RS EAS 847-17, Cosmetics — Analytical methods — Part 17: Determination of pH

RS EAS 847-16, Cosmetics — Analytical methods — Part 16: Determination of lead, mercury and arsenic
content

AOAC 997.07, N-octyl Bicycloheptene dicarboximide (MGK 264), Pyrethrins and Piperonyl Butoxide (PB) in
Technical materials, concentrates and Finished Products.

RS 394-1, Mosquito repellents ― Performance Test Guidelines ― Part 1: Skin applied repellents

RS 91, Labelling and marking of pharmaceutical products — Specification

RS ISO 24153, Random sampling and randomization procedures

3 Terms and definitions

For the purposes of this standard, the terms and definitions given in RS EAS 846 and the following apply.

1 ©RSB 2021 - All rights reserved

3.1

mosquito

any of numerous arthropod animals of the class mosquito, having an adult stage characterized by three pairs
of legs and a body segmented into head, thorax, and abdomen and usually having one or two pairs of wings

3.2

mosquito repellent

substance applied to skin, clothing, or other surfaces which discourages mosquito (and arthropods in general)
from landing or climbing on that surface

3.3

natural repellents/biopesticides

repellents that contain natural, plant-based compounds or other products approved by a competent authority

3.4

synthetic repellents

conventional repellents containing synthetic chemical compounds

3.5

roll-on

cosmetic preparation with the effect of deodorizing and providing antiperspirant properties to the body of the
user. It is packed in a container fitted with a roll-ball

3.6

roll-ball

spherically shaped object, with the capacity to roll in all directions. It is put at the opening of a roll-on container
and serves the role of closing the container as well as dispensing the contents, when rolled on the skin

3.7

competent authority

ministry or government institution in charge of registration of pharmaceutical products

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DRS 392-2: 2021

4 Requirements

4.1 General requirements

4.1.1 The repellent shall contain required amounts of active ingredients and when applied to the skin shall
have the effect of repelling insects. The repellent shall be in the form of:

 a) Sprays: This shall consist of a liquid formulation that is blown or driven through the air in the form of
 tiny drops and which contains active ingredient(s), and/or synergist(s) and other formulants including
 solvents,
 b) Roll-ons: The product may also be in form of cosmetic preparation meant to be applied as a roll-on,
 and which contains active ingredient(s), synergist(s) and/or other formulants

4.1.2 The formulation shall be of uniform colour and shall be free from visible impurities.

4.1.3 All ingredients shall meet the requirements of RS EAS 377.

4.1.4 When applied to the skin, clothes or shoes, the product shall have the benefit of repelling mosquitoes
and shall not have a harmful effect to the skin.

4.2 Active ingredients and synergists

4.2.1 Natural repellents

4.2.1.1 Active ingredients used in natural repellents shall be natural plant based active ingredients such as
essential oils or any other plant extract approved as mosquito repellents.

4.2.1.2 The manufacturer shall provide adequate data on the repellence of such ingredients.

4.2.1.3 The manufacturer shall have adequate data justifying the proportion of ingredient(s) for which claims
are made, used in the product.

4.2.1.4 The essential oils used in natural repellents shall be safe for users and provide the required efficacy.
The annex A gives some ingredients (essential oils) and safe concentration commonly used in natural
repellents.

4.2.1.5 The concentration of plant-based active ingredient and recommended application shall be safe to the
user and provide the required efficacy. The annex B provides the efficacy of some plant-based mosquito
repellents.

4.2.2 Synthetic repellents

4.2.2.1 Synthetic repellents shall contain synthetic chemical compound (s) or their mixture with natural
compounds, which are able to discourage mosquitoes and send them flying or crawling away.

4.2.2.2 The concentration of the active ingredients and the recommended application/use shall ensure the
declared efficacy and shall be safe and proved by scientific evidence.

3 ©RSB 2021 - All rights reserved

4.2.2.3 Synthetic repellents and their active ingredients shall be approved and registered by competent
authority before being released to the market. The annex C gives the list of some of active ingredients used in
synthetic repellents.

4.2.3 Synergist content

4.2.3.1 The synergist content shall be declared and, when determined, the average content measured shall
not differ from that declared.

4.2.3.2 The synergist shall be PBO, sesame seed oil (sesamin, sesamolin) and/or MGK 264. The synergist
shall be tested in accordance with AOAC 997.07. The ratio of the active ingredient to the synergist shall be
indicated and records availed.

4.2.3.3 The ratio of the active ingredient to the synergist shall be at the ratio range of 1 to 10 parts
exponent’s active ingredient to 1 part of an insecticide’s active ingredient.

4.3 Specific requirements

The product shall comply with the specific requirements given in table 1 when tested in accordance with the
methods indicated therein.

 Table 1 — Specific requirements

 S/N Parameters Requirements Test methods
 i. pH 3–7 RS EAS 847-17
 ii. Non-volatile matter, % m/m, min. 10 Annex D
 iii. Lead (Pb) , , mg/kg, max 20 RS EAS 847-16
 iv. Arsenic (As), mg/kg, max 2

 v. Mercure (Hg), mg/kg, max 2

4.4 Biological efficacy

When tested in accordance with RS 394-1, the product shall repel 100 % of the mosquitoes from landing or
climbing on that surface, within protection time indicated by the manufacturer.

5 Packaging and labelling

5.1 Packaging

5.1.1 The container of spray repellent shall be suitable in order to protect the contents and shall not react
with the product or cause any contamination during storage, handling or use.

5.1.2 The roll-on container shall be fitted with a roll-ball and the roll-ball shall be:

a) made of plastic material

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DRS 392-2: 2021

b) fitting on the container such that on holding the container inside down the contents shall not pour out.

c) be free rolling, leaving a thin layer of the contents on the skin during dispensation

5.2 lLabelling

The containers shall be securely closed and in addition to the labelling requirements of RS 91, the following
information shall be indelibly and legibly marked on the container:

a) name of the product;

b) name and full address of the manufacture;

c) batch number;

d) date of manufacture and expiry;

e) quantity in the container;

f) active ingredient content, (%, m/m);

g) list of other ingredients;

h) net mass of content;

i) directions for use;

j) safety precaution;

k) special persons whose exposure is prohibited (out of reach of children and pregnant women); and

l) storage conditions.

6 Sampling

Random samples of the product shall be drawn for test in accordance with RS ISO 24153 from the market,
factory or anywhere else.

5 ©RSB 2021 - All rights reserved

Annex A
 (informative)

Some common essential oils in natural repellents that may be hazardous

 Table A1 – Some common ingredients (essential oils) in natural repellents that may be hazardous
Common name Scientific name Safe concentration Hazard
 (%)
Anise Pimpinella anisum 3.6 Based on 0.11% methyl eugenol; carcinogen.
Basil Ocimum sp. 0.07 Based on 6% methyl eugenol; carcinogen.
Bergamot Citrus aurantium 0.1 Sensitising and phototoxic; skin irritant.
 bergamia
Cajeput Melaleuca alternifolia 0.004 Based on 97% methyl eugenol; carcinogen.
Cedar Chamaecyparis 1 Likely allergenic contaminants if nootkatone
 nootkatensis not 98% pure.
Cinnamonium Cinnamonium cassia 9 Sensitising skin irritant
 Cinnamomum verum 0.05 Based on 75.5% of cinnamaldehyde,
 sensitising skin irritant.
Citronella Cymbopogon nardus 2 Safety is controversial; based on 0.2% methyl
 eugenol or 1.3% citral; sensitising skin irritant.
 18.2 Based on 29.1% geraniol, sensitising skin
 irritant.
Citronella (java) Cymbopogon 2 Based on 2% methyl eugenol; carcinogen.
 winterianius
Citrus oils Citrus sp. 16 – 25 Based on 0.005 % - 0.0025 % bergapten;
 phototoxic skin irritant
Clove Syzyguim aromaticum 0.5 Based on 92% eugenol; sensitising skin
 irritant.
Eucalyptus E. globulus, 20 High in 1,8-Cineole can cause Central
 E.globulusmaidenii; E. Nervous System (CNS) and breathing
 radiate; problems in young children.
 E. smithii,
 E. camaldulensis
Fever tea, lemon Lippie javanica 2 Based on 5% citral in related species;
bush sensitising skin irritant.
Geranium Pelargonium 6 Based on 1.5% citral; sensitising skin irritant.
 graveolens
 Pelargonium x asperum 17.5 Based on 30.3% geraniol; sensitising skin
 irritant.
Ginger Zingber sp. 12 Based on 0.8 citral; sensitising skin irritant.
Huon oil, Macquarie Langarostrobus franklini 0.004 Bsed on methyl euginol; carcinogen.
pine
Lemongrass Cymbopogon citrates 0.1 Based on 90% citral; sensitising skin irritant.
Lime Citrus aurantifolia 0.7 Phototoxic skin irritant.
Litsea Litsea cubeba 0.1 Based on 78% cotral; sensitising skin irritant
Marigold Tagates minuta 0.01 Phototoxic skin irritant
Mint Menthe piperata and 2 Based on 0.1% trans-2-hexenal; sensitising
 spicata skin irritant.
Nutmeg Myristica fragrans 0.4 Based on 1% methyl eugenol; carcinogen.
Palmarosa Cymbopogon martini 16 Based on 1.2% farnesol; sensitizing skin
 irritant.

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DRS 392-2: 2021

Pine Pinus sylvestris Prepare with Oxidation creates phototoxic skin irritants
 antioxidants
Rosemary Rosemarinus officinalis 36 Based on 0.011% methyl eugenol;
 carcinogen.
 16.5 High in Camphor CT (Chemotype)
 22 High in α-Pinene CT
 6.5 High in Verbenone CT
Rue Ruta chalepensis 0.15 Based on presence of psoralenes; phototoxic
 skin irritant.
Tea tree Melaleuca bracteata 0.0004 Based on 97.7% of methyleugenol,
 sensitising skin irritant.
 Leptospermum 0.6 Based on 76.7% Citral (Geranial +Neral),
 petersonii (lemon sensitising skin irritant.
 scented)
Thyme Thymus vulgaris 2 Based on 0.1% trans-2-hexenal; sensitising
 skin irritant.
Violet Viola odorata 2 Based on 0.1% trans-2-hexenal; sensitizing
 skin irritant.
Ylang-ylang Canagium odoratum 2 Based on 4% farnesol; sensitizing skin
 irritant.

 .

7 ©RSB 2021 - All rights reserved

Annex B
 (informative)

 Plant-based insect repellents: a review of their efficacy, development
 and testing1

Plant-based repellents have been used for generations in traditional practice as a personal protection
measure against host-seeking mosquitoes. Knowledge on traditional repellent plants obtained through
ethnobotanical studies is a valuable resource for the development of new natural products. Recently,
commercial repellent products containing plant-based ingredients have gained increasing popularity among
consumers, as these are commonly perceived as “safe” in comparison to long-established synthetic repellents
although this is sometimes a misconception. The table E1 gives an overview of repellent plant efficacy from
literature review.

 Table B1 – An overview of repellent plant efficacy from literature review
 Plant Location Other names Repellent Tested mode of Repellency %
 compound (s) use protection
 MYRTACEAE
Corymbia citriodora Australia Lemon Citronellal PMD 30% PMD applied 96.88% protection
 Brazil eucalyptus (by product of topically from mosquitoes
 Bolivia Lemon hydrodistillation) for 4 hours
 China scented (p-methane-3,8- PMD towelette 90% protection
 India Gum diol) (0.57g) applied from An. Arabiensis
 Ethiopia Quwenling Citronellol topically for 6 hours.
 Tanzania Limonene 50% PMD applied 100% protection
 Kenya Geraniol topically from An. Gambiae
 Isopulegol and An. Funestus
 δ-pinene for 6 – 7 hours.
 20% PMD (1.7 100% protection for
 mg/cm2) applied 11 – 12 hours
 topically. against A.
 stephensi.
 20% PMD applied 100% protection
 topically against Ae. Aegypti
 for 120 minutes.
 Thermal expulsion 78.7% protection
 (leaves) from An.
 Arabiensis.
 Direct burning 70.1% protection
 (leaves) from An. arabiensis
 Periodic thermal 74.5% protection
 expulsion (leaves) from An. Gambiae
 s.s.

1 Marta Ferreira Maia and Sarah J. Moore, Plant-based insect repellents: a review of their efficacy, development and
testing. Malaria Journal, 2011.

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DRS 392-2: 2021

 Periodic direct 51.3% protection
 burning (leaves) from An. Gambiae
 s.s.
 Thermal expulsion 48.71% protection
 (leaves) from An. Gambiae
 s.l.
Eucalyptus spp. Guinea-Bissau Eucalyptus 1,8-cineole Thermal expulsion 72.2% protection
 Ethiopia citronellal (leaves) from mosquitoes
 Tanzania Z- and α- citral for 2 hours.
 Portugal α- pinene
E. camaldulensis Ethiopia Thermal expulsion 71.9% protection
 (leaves) from An.
 Arabiensis.
 72.2% protection
 from An.
 Pharaoensis.
 Direct burning 65.3% protection
 (leaves) from An.
 Arabiensis.
 66.6% protection
 from An.
 Pharaoensis.
Eugenia India Clove lavang Euginol 100% essential oil 100% protection
caryophyllus or cravinho-da- Carvacrol applied topically against Ae. aegypti
Syzygium india Thymol for 225 minutes
aromaticum or Cinnamaldehyde 100% protection
Eugenia aromatic against An.
 Albimanus for 213
 minutes
 100% essential oil 100% protection
 applied topically against Ae. aegypti
 for 120 min.
 100% protection
 against C.
 quinquefasciatus
 for 240 min.
 100% protection
 against An. Dirus
 for 210 min.
 VERBENACEAE
lippia spp. Kenya Lemon bush Myrcene
 Tanzania Linalool
 Ghana α- pinene
 Zimbabwe eucalyptol
L. javanica Alloparinol 5 mg/cm2 plant 100% protection
 Camphor extract applied against Ae. aegypti
 Limonene topically for 8 hours
 α- terppeneol Alcohol plant 76.7% protection
 verbenone extract applied against An.
 topically Arabiensis for 4
 hours
L. uckambensis Fever tea Potted plant 33.3% protection
 against An.
 Gambiae s.s
 Periodic thermal 45.9% protection
 expulsion (leaves) against An.

9 ©RSB 2021 - All rights reserved

Gambiae s.s
 Periodic direct 45.9% protection
 burning (leaves) against An.
 Gambiae s.s
 Potted plant 25.01% protection
 against An.
 Gambiae s.s
L. cheraliera Eucalyptol
 Caryophyllene
 Ipsdienone
 p-cymene
Lantana camara Kenya Lantana Caryophylene Potted plant 32.4% protection
 Tanzania Spanish flag against An.
 West Indian Gambiae s.s
 Lantana Potted plant 27.22% protection
 Wild sage against An.
 Gambiae s.l
 Flower extract in 94.5% protection
 coconut oil against aegypti and
 ae. albopictus for
 one hour
 Periodic thermal 42.4% protection
 axpulsion (leaves) against An.
 Gambiae s.s
 LAMIACEAE
ocimum spp. O. Kenya Tree basil p-cymene Potted plant 39.70% protection
americanum Tanzania Nchu avum estragosl against An.
 Zimbabwe Lime basil linalool Gambiae s.s
 Nigeria Kivumbasi linoleic acid Potted plant 37.91% protection
 Ghana Myeni eucalyptol against An.
 Cameroon Madongo eugenol Gambiae s.l
 Eritrea African blue camphor Fresh plants 50% protection
 Ethiopia (…) Basil citral combined with O. against An.
 Hairy basil thujone suavebruised and Gambiae s.l
 limonene applied topically
 ocimene Periodic thermal 43.1% protection
 and others axpulsion (leaves against An.
 and seeds) Gambiae s.s
 Periodic direct 20.9% protection
 burning (leaves against An.
 and seeds) Gambiae s.s
 100% essential oil 100% protection
 combined with against Ae. aegypti
 vanillin 5% applied for 6.5 hours
 topically 100% protection
 against C.
 quinquefasciatus
 for 8 hours
 100% protection
 against An. Dirus
 for 8 hours
O. suave Thermal expulsion 73.6% protection
 (leaves) from An. Arbiensis
 75.1% protection
 against An.

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DRS 392-2: 2021

 pharaoensis
 Direct burning 71.5% protection
 (leaves) from An. arbiensis
 79.7% protection
 against An.
 pharaoensis
 Periodic thermal 53.1% protection
 expulsion (leaves from An. gambiae
 and seeds) s.s.
 Periodic direct 28.0% protection
 burning (leaves from An. gambiae
 and seeds) s.s.
O. basilicum Thermal expulsion 78.7% protection
 (leaves) from An. arabiensis
 79.2% protection
 from An.
 pharaoensis
 Direct burning 73.1% protection
 (leaves) from An. arabiensis
 70.0% protection
 from An.
 pharaoensis
 100% essential oil 100% protection for
 applied topically 70 minutes.
O. Thermal expulsion 44.54% protection
kilimandscharikum (leaves and against An.
 seeds) gambiae s.l.
 Thermal expulsion 37.63% protection
 (leaves and against An.
 seeds) funestus.
 Periodic thermal 52.0% protection
 expulsion (leaves against An.
 and seeds) gambiae s.s.
 Periodic direct 26.4% protection
 burning (leaves against An.
 and seeds) gambiae s.s.
O. forskolei Fresh plants hung 53% protection
 indoors against mosquitoes
 entering human
 dwelling
Hyptis spp. Hyptis Kenya Bushmint Myrcene Smouldering on 85.4% repellency
suaveolens Tanzania Wild hops charcoal against mosquitoes
 Ghana Wild for 2 hours
 The Gambiae Spikenard Fresh leaves 73.2% repellency
 Hangzimu against mosquitoes
 Hortela-do- for 2 hours.
 campo Periodic direct 20.8% repellency
 burning (leaves against An.
 and flowers) gambiae s.s.
Menthe spp. M. Brazil Hortela-do- 100% essential oil 100% protection
piperata Bolivia campo applied topically against Ae. aegypti
 Peppermint for 45 minutes.
M. arvensis Menta 100% essential oil 41% protection
 Japanese volatilized in a against indoors
 mint kerosene lamp against Mansonia
 spp.

11 ©RSB 2021 - All rights reserved

Thymus spp. Th. China Thyme α- terpinene α- terpinene 97.3% protection
vulgaris Former Soviet carvacrol topically against Culex
 Union Korea thymol pipiens sallens for
 Middle-East p-cymene 82 min.
 Mediterranean linalool Carvacrol topically 94.7% protection
 geraniol against C. pipiens
 sallens for 80 min.
 Thymol topically 91.8% protection
 against C. pipiens
 sallens for 70 min
 Linalool topically 91.7% protection
 against C. pipiens
 sallens for 65 min
 p-cymene 89.0% protection
 against C. pipiens
 sallens for 45.2 min
 100% essential oil 100% protection
 applied topically against An.
 Arbimanus for 105
 min and Ae.
 aegypti for 135 min.
 Direct burning 85-90% protection
 (leaves) for 60-90 min.
Pogostemon spp. China Patchouli 100% essential oil 100% protection
 applied topically against Ae. aegypti
 for 120 min.
Pogostemon cablin India Oriza 100% essential oil 100% protection
 Malaysia applied topically against C.
 Thailand quinquefasciatus
 for 150 min.
 100% protection
 against An. Dirus
 for 710 min.
 POACEAE
Cymbopogon China
 India
 Indonesia
C. nardus Brazil citronellal 40% essential oil 100% protection for
 applied topically 7-8 hours against
 An. Stephensi
 100% essential oil 100% protection
 applied topically against Ae. Aegypti
 for 120 min.
 100% protection
 against C.
 quinquefasciatus
 for 100 min.
 100% protection
 against An. dirus
 for 70 min.
 10% essential oil 100% protection
 applied topically against Ae. Aegypti
 for 20 min.
C. martini Tanzania palmarosa geraniol 100% essential oil 100% protection
 Kenya applied topically against An.

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DRS 392-2: 2021

 culicifacies for 12
 hours.
 96.3% protection
 against C.
 quinquefasciatus
 for 12 hours.
 Topically (100% 98.8% protection
 essential oil) against C.
 quinquefasciatus
 for 10 hours.
C. citratus USA Lemongrass Citral α- pinene Topically (100% 74% protection
 South Africa oil essential oil) against An. Darling
 Bolivia for 2.5 hours
 95% protection
 against Mansonia
 spp. for 2.5 hours
 Methanol leaf 78.8% protection
 extract applied against An.
 topically Arabiensis for 12
 (2.5mg/m2) hours
 100% essential oil 100% protection for
 applied topically 30 minutes.
C. winterianius 100% essential oil 100% protection
 combined with against Ae. Aegypti
 vanillin 5% applied for 6.5 hours
 topically 100% protection
 against C.
 quinquefasciatus
 for 8 hours
 100% protection
 against An. Dirus
 for 8 hours
C. excavatus Alcohol plant 66.7% protection
 extract applied againstAn.
 topically Arabiensis for 3
 hours
Pelargonium Rose Alcohol plant 63.3% protection
reniforme Geranium extract applied againstAn.
 topically Arabiensis for 3
 hours
 MELIACEAE
Azadirachta indica India Neem Azadirachtin Direct burning 76.0% protection
 Sri Lanka saponins (leaves) from mosquitoes
 China for 2 hours
 Brazil Periodic thermal 24.5% protection
 Bolivia expulsion (leaves) from An. Gambiae
 Pakistan s.s.
 Ethiopia 1% neem oil 94.2% protection
 Guinea Bissau volatilized in a from Anopheles
 Kenya kerosene lamp spp.
 Tanzania (…) 80% protection
 from Culex spp.
 2% neem oil 56.75% protection
 applied topically from mosquitoes
 for 4 hours
 ASTERACEAE

13 ©RSB 2021 - All rights reserved

Tagetes minuta Uganda Khaki weed Topically 86.4% protection
 Zimbabwe against An.
 India Stephensi for 6
 hours
 Topically 84.2% protection
 against C.
 quinquefasciatus
 for 6 hours
 Topically 75% protection
 against Ae. Aegypti
 for 6 hours
 Fresh leaves Reduced human
 (4Kg) landings indoors
Artemisia ssp.
A. vulgalis India Mugwort Camphor
 Egypt wormwood Linalool
 Italy St. Johns Terpenen-4-ol
 Canada plant α- and β- thujone
 USA Old uncle β- pinene
 henry
 Sailors
 Tobacco
A. monosperma Siberia Felon herb Myrcene 5% leave extract 100% protection for
 Brazil Naughty man Limonene applied topically 4 hours
 Cineol
 CAESALPINIACEAE
Daniellia oliveri Guinea-Bissau Churai Direct burning 77.9% protection
 The Gambiae Santao (bark) against mosquitoes
 Santang for 2 hours
 Santango Direct burning 77% protection
 (bark) against mosquitoes
 FABACEAE
Glycine max Worldwide Soya 2% soya bean oil 100% protection
 against Ae. Aegypti
 for 95 minutes
 RUTACEAE
Zanthoxylum Thailand makaen 100% essential oil 100% protection
limonella applied topically against Ae. Aegypti
 for 120 minutes
 100% protection
 against C.
 quinquefasciatus
 for 170 minutes
 10% essential oil 100% protection
 combined with against An. dirus
 vanillin 5%applied for 95 minutes
 topically
Citrus hystrix Indonesia Kaffir lime 100% essential oil 100% protection
 Malaysia Limau combined with against An.
 Thailand Purut vanillin 5% applied Stephensi for 8
 Laos topically hours
 100% protection
 against Ae. Aegypti
 for 3 hours
 100% protection

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DRS 392-2: 2021

 against C.
 quinquefasciatus
 for 1.5 hours
 100% protection
 against An. dirus
 for 2.5 hours
 ZINGIBERACEAE
Curcuma longa Turmeric 100% essential oil 100% protection
 Curcuma combined with against Ae. Aegypti
 Indian saffron vanillin 5% applied for 4.5 hours
 topically 100% protection
 against C.
 quinquefasciatus
 for 8 hours
 100% protection
 against An. dirus
 for 8 hours

15 ©RSB 2021 - All rights reserved

Annex C
 (informative)

 Active ingredients for synthetic repellents

 Table C1 – List of some active ingredients for synthetic repellents
 Active ingredient Assessing risks to Health Assessing risks to Environment
DEET Large doses of DEET have been DEET is absorbed quickly through
DEET, which is an acronym for N,N- linked to skin blisters, seizures, the skin: one study showed that 48%
Diethyl-meta-toluamide, is one of the memory loss, headaches, stiffness in of the applied dose is totally
most effective bug repellents and also the joints shortness of breath, and absorbed within six hours. When
repels ticks. skin irritation. DEET is also linked to mixed with the sunscreen chemical
 neurotoxicity that may lead to oxybenzone, it was found to be
 physiological and behavioral absorbed even more quickly. DEET
 problems, especially with motor skills, has been shown to cross the
 and learning and memory placenta: in animal studies, DEET
 dysfunction. was found in the fetus and in
 newborns up to three months old
 after exposing the mother to the
 chemical.
IR 3535 IR3535 has been used as an insect Because the active ingredient is used
3-[N-Butyl-N-acetyl]-aminopropionic repellent in Europe for 20 years with only in products applied to human
acid, ethyl ester is structurally related no substantial adverse effects. skin, no risks to the environment are
to #-alanine, which occurs naturally. Toxicity tests show that the IR3535 is expected..
The active ingredient is a liquid at not harmful when ingested, inhaled,
room temperature. or used on skin. Eye irritation could
 occur if the chemical enters a
 person=s eyes. Any allergic reactions
 are required to be reported to EPA
PMD (p-Menthane-3,8-diol In studies using laboratory animals, Based on laboratory animal studies,
p-Menthane-3,8-diol occurs naturally p-Menthane-3,8-diol shows no p-Menthane-3,8-diol poses minimal
in the lemon eucalyptus plant. The adverse effects except for eye or no risks towildlife. Because of the
natural oil can be extracted from the irritation. Therefore, special low toxicity and limited uses of p-
eucalyptus leaves and twigs. For precautions were put on the label to Menthane-3,8-diol, it is notharmful to
commercial use, the active ingredient prevent the product from contacting the environment
is chemically synthesized. p- people's eyes. For example, "Do not
Menthane-3,8-diol is structurally get in eyes. Do not apply on face or
similar to menthol. hands of small children." and "Do not
 spray directly on or near face.
 Instead, spray in palm of hand and
 spread on face and neck." If used
 according to label instructions, p-
 Menthane-3,8-diol is not expected to
 pose health risks to people, including
 children and other sensitive
 populations.
Picardin Picaridin generally is of low acute Based on the ecological effects data
1-(1-methylpropoxycarbonyl)-2-(2- toxicity, and based on the available submitted by the registrant, the
hydroxyethyl) piperidine or 2-(2- toxicological data, the Agency Agency concluded that the product
hydroxyethyl)-1-piperidinecarboxylic believes that the normal use of should pose no risks to terrestrial and
acid 1-methylpropyl ester. Picaridin is Picaridin does not present a health aquatic organisms from the proposed
 concern to the general U.S. use pattern. The use should provide
an insect repellent that is applied
 population non-target organisms extremely
directly to the skin. Picaridin appears limited access to the chemical.
to work by preventing the mosquito

©RSB 2021 - All rights reserved 16

DRS 392-2: 2021

finding or recognizing its host.
Picaridin products can be formulated
as solids, liquids, sprays, aerosols, or
wipes.
2-undecanone Based on the current use patterns Due to the repellent nature of the
Methyl nonyl ketone is a dog and cat and exposure profiles for methyl product, risks to non-target terrestrial
repellent/training aid and iris borer nonyl ketone, no dietary or species is not likely. In addition, non-
deterrent. The pesticide is used in occupational risk characterizations target aquatic species exposure is
households, paths, patios, solid waste are required unlikely because this chemical is
containers and on ornamental plants. since residues in or on food/feed are neither persistent nor mobile in the
Methyl nonyl ketone is not expected to occur and no environment and associated use
formulated as a pressurized liquid, toxicological endpoints of concern for patterns.
granular, liquid ready-to-use either short or intermediated terms
(pump/sprayer), solid (crystalline), were identified.
and liquid for reformulating use only.
EPA assumes that the volume of use
of this pesticide is relatively low.

17 ©RSB 2021 - All rights reserved

Annex D
 (normative)

 Non-volatile matter

D.1 Apparatus

D.1.1 Moisture dish

D.1.2 Oven

D.1.3 Analytical balance

D.1.4 Desiccator

D.2 Procedure

Weigh accurately 1g ± 0.2 g of the sample in the dish and place it in an oven at 105 °C ± 2°C for 1 h. Cool to
room temperature in a desiccator and weigh the dish. Repeat the process to bring it to constant mass.

D.3 Calculation

 M2−M1
Non-volatile matter per cent by mass = = 100
 
Where,

M = mass, in grams of the material taken;

M1 = mass in grams of the dry and empty dish, and

M2= mass in grams of the dish and dried material.

©RSB 2021 - All rights reserved 18

DRS 392-2: 2021

 Bibliography

[1] USPC/USP Pharmacopeial Forum 2009 (Vol. 35 (3), Topical and Transdermal Drug Products

[2] Manual on development and use of FAO and WHO specifications for pesticides, November 2010, 2 nd
Edition.

[3] Product Performance Test Guidelines. OPPTS 810.3700: Insect Repellents to be applied to human Skin

[4] Official Methods of Analysis of AOAC International, 19th Edition, 2012, volume I

[5] Robert Tisserand and Rodney Young, Essential oils safety: A guide for health care Professionals, 2014.

[6] K. Husnu Can Baser and Gerhard Buchbauer, Handbook of Essential oils – Science, technology and
applications, 2010.

[7] Marta Ferreira Maia and Sarah J. Moore, Plant-based insect repellents: a review of their efficacy,
development and testing, Malaria Journal, 2011.

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DRS 392-2: 2021

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