GHS Classification Result

Chemical Name:Indole
CAS:120-72-9

Result:
ID: 22A4186
Classifier: Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
Year Classified: FY2010
Reference Manual: GHS Classification Guidance by the Japanese Government (July, 2010)

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Explosives Not applicable - - - - There are no chemical groups associated with explosive properties present in the molecule.
2 Flammable gases (including chemically unstable gases) Not applicable - - - - Solid (GHS definition)
3 Aerosols Not applicable - - - - Not aerosol products.
4 Oxidizing gases Not applicable - - - - Solid (GHS definition)
5 Gases under pressure Not applicable - - - - Solid (GHS definition)
6 Flammable liquids Not applicable - - - - Solid (GHS definition)
7 Flammable solids Classification not possible - - - - No data available.
8 Self-reactive substances and mixtures Not applicable - - - - There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
9 Pyrophoric liquids Not applicable - - - - Solid (GHS definition)
10 Pyrophoric solids Classification not possible - - - - No data available.
11 Self-heating substances and mixtures Classification not possible - - - - Test methods applicable to solid (melting point <= 140 degC) substances are not available.
12 Substances and mixtures which, in contact with water, emit flammable gases Not applicable - - - - The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).
13 Oxidizing liquids Not applicable - - - - Solid (GHS definition)
14 Oxidizing solids Not applicable - - - - Organic compounds containing no oxygen, fluorine or chlorine.
15 Organic peroxides Not applicable - - - - Organic compounds containing no bivalent -O-O- structure.
16 Corrosive to metals Classification not possible - - - - The substance is a solid and its melting point is less than 55 degC, but classification is not possible due to lack of additional data.

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity (Oral) Category 4 Warning H302: Harmful if swallowed P301+P312: IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P330: Rinse mouth.
P501: Dispose of contents/container to ...
Based on the rat LD50 value of 1000 mg/kg bw (JECFA WHO FOOD ADDITIVES SERIES 54 (2006)), the substance was classified into Category 4.
1 Acute toxicity (Dermal) Category 3 Danger H311: Toxic in contact with skin P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P312: Call a POISON CENTER or doctor/physician if you feel unwell.
P322: Specific treatment (see ... on this label).
P361: Remove/Take off immediately all contaminated clothing.
P363: Wash contaminated clothing before reuse.
P405: Store locked up.
P501: Dispose of contents/container to ...
Based on the rabbit LD50 value of 790 mg/kg bw (RTECS (2003), original literature: American Industrial Hygiene Association Journal. Vol 23, page 95 (1962)), the substance was classified as Category 3.
1 Acute toxicity (Inhalation: Gases) Not applicable - - - - Solid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Classification not possible - - - - No data available.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible - - - - No data available.
2 Skin corrosion/irritation Classification not possible - - - - No data available.
3 Serious eye damage/eye irritation Category 2A Warning H319: Causes serious eye irritation P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+P313: If eye irritation persists: Get medical advice/attention.
P264: Wash ... thoroughly after handling.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
The substance was classified as Category 2A based on the document that irritation score was 8 (maximum score 10 by grading according to 10 ranks) (HSDB (2003)). As relevant notes, severe irritant result in the standard Draize test was reported in datum from the "List 3" information source designated in the GHS classification guidance for the Japanese government (RTECS (2003)).
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Classification not possible - - - - No data available.
5 Germ cell mutagenicity Classification not possible - - - - The classification was not possible due to lack of in vivo test data. As relevant information, as for in vitro study, negative results in the Ames test were reported (JECFA WHO FOOD ADDITIVES SERIES 54 (2006)).
6 Carcinogenicity Classification not possible - - - - In the 560-day dietary administration test using rats at the dose level corresponding to 100 mg/kg bw/day, no tumors in relation to the administration of this substance was observed (JECFA WHO FOOD ADDITIVES SERIES 54 (2006)). However, because the histological examination was carried out for the limited organs such as liver, kidney, and spleen, it was insufficient to evaluate the carcinogenicity. No other data were obtained, therefore, it was concluded as "Classification not possible" due to lack of data.
7 Reproductive toxicity Classification not possible - - - - No data available.
8 Specific target organ toxicity - Single exposure Classification not possible - - - - No data available.
9 Specific target organ toxicity - Repeated exposure Classification not possible - - - - In the 21-day feeding study in male rats, there were no significant differences between the treatment groups which reached 375 mg/kg/day (converted dose level as that of 90-day study: 87.5 mg/kg/day) for the high dose group and the control group except for reductions in body weight gain and food consumptions (JECFA WHO FOOD ADDITIVES SERIES 54 (2006)). In addition, in the 560-day feeding study in rats administered at the dose level corresponding to 100 mg/kg/day, no adverse effects containing histopathological findings were reported except for slight reversible anemia (JECFA WHO FOOD ADDITIVES SERIES 54 (2006)). In the 21-day feeding study described above, histopathological examination was not conducted, and in the 560-day feeding study the organs examined for histopathology were limited to the liver, kidney and spleen. Thus, both of these studies was not enough to meet the requirement of the repeated dose study. Therefore, the substance was concluded as "Classification not possible" due to lack of sufficient data.
10 Aspiration hazard Classification not possible - - - - No data available.

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment (Acute) Category 1 Warning H400: Very toxic to aquatic life P273: Avoid release to the environment.
P391: Collect spillage.
P501: Dispose of contents/container to ...
Classified into Category 1 from its 48h-LC50 = 1.0 mg/L for crustacea (Daphnia magna) (AQUIRE, 2011).
11 Hazardous to the aquatic environment (Long-term) Not classified - - - - Classified as "Not classified" since it is rapidly degradable (4w-BOD degradation rate tested by OECD TG301C: 89 - 92% (Biodegradation and Bioconcentration of Existing Chemical Substances under the Chemical Substances Control Law, 2007)) and its bioaccumulation potential is estimated to be low (LogPow = 2.14 (PHYSPROP Database, 2011)) though its acute toxicity is Category 1.
12 Hazardous to the ozone layer Classification not possible - - - - This substance is not listed in Annexes to the Montreal Protocol.


NOTE:
* Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government, and is intended to provide a reference for preparing GHS labelling and SDS for users.
* This is a provisional English translation of classification results and is subject to revision without notice.
* The responsibility for any resulting GHS labelling and SDS referenced from this site is with users.

Reference:
Reference Manual

Definitions / Abbreviations

Model Label by MHLW

MHLW Website (in Japanese Only)

Model SDS by MHLW

MHLW Website (in Japanese Only)


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