GHS Classification Result (Revision of the past classification result)

Chemical Name:3-Amino-1H-1,2,4-triazole, (alias Amitrole)
CAS:61-82-5

Result:
ID: 21B3075
Classifier: Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
Year Classified: FY2009
Reference Manual: GHS Classification Guidance by the Japanese Government (March, 2009)

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 molecules.
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 Not classified - - - - nonflammable(IUCLID(2000))
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 Not classified - - - - Classified into Not classified since auto-ignition point is >225 degC (IUCLID (2000)) exceeding 70 degC.
11 Self-heating substances and mixtures Not classified - - - - nonflammable (IUCLID(2000))
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 - - - - The substance is an organic compound containing no oxygen, fluorine or chlorine in the molecule.
15 Organic peroxides Not applicable - - - - Organic compounds containing no bivalent -O-O- structure
16 Corrosive to metals Classification not possible - - - - Test methods applicable to gaseous substances are not available. Information is available that the substance attacks steel and aluminum (ICSC (J) (1994)).

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity (Oral) Not classified - - - - Based on LD50 values of 25000 mg/kg (ACGIH (2001)) and 24600 mg/kg (EHC 158 (1994)) for rats, the substance was classified into "Not classified".
1 Acute toxicity (Dermal) Not classified - - - - Based on LD50 values of >2500 mg/kg for rats (EHC 158 (1994)) and >10000 mg/kg for rabbits (EHC 158 (1994)), the substance was classified as "Not classified".
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 - - - - Classification not possible due to lack of data. As relevant information, a LC50 (4h) value was >0.439 mg/L for rats (ACGIH (2001)).
2 Skin corrosion/irritation Not classified - - - - In two rabbit skin irritation tests, it is reported that mild erythema, which was resolved by 48-hour, was observed at the high-dose level only, and the irritancy of this substance was very mild (EHC 158 (1994), ACGIH (2001)). There are reports of mild cases of dermatitis due to occupational exposure and from patch tests, where a slight irritant effect was observed in three out of six volunteers after 24-hour application (EHC 158 (1994)). Based on these data, the irritancy of this substance is considered to be mild or very mild. The substance was classified as "Not classified" in JIS Classification (correspond to Category 3 in GHS classification).
3 Serious eye damage/eye irritation Category 2B - Warning H320: Causes 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.
Although there is a report that mild irritation was observed in rabbit tests (EHC 158 (1994), ACGIH (2001), IUCLID (2000)), the majority of animals had recovered by 24-hour (EHC 158 (1994)). Based on the results, the substance was classified into Category 2B.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Category 1 Warning H317: May cause an allergic skin reaction P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P333+P313: If skin irritation or rash occurs: Get medical advice/attention.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P272: Contaminated work clothing should not be allowed out of the workplace.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P321: Specific treatment (see ... on this label).
P363: Wash contaminated clothing before reuse.
P501: Dispose of contents/container to ...
Based on positive results in a guinea pig maximization test (EHC 158 (1994), DFGOT vol. 18 (2002)) and a report of a case test in which a weed control operator with a history of contact dermatitis showed a strong positive reaction in a patch test, indicative of allergic contact dermatitis (DFGOT vol. 18 (2002), EHC 158 (1994)), the substance was classified into Category 1.
5 Germ cell mutagenicity Not classified - - - - Based on negative results in two dominant lethal tests by oral administration to mice (in vivo heritable mutagenicity tests) (EHC 158 (1994)) and three bone marrow micronucleus tests by oral or intraperitoneal administration to mice (in vivo somatic cell mutagenicity tests) (IARC 79 (2001), EHC 158 (1994)), the substance was classified as "Not classified". As relevant information, from in vitro mutagenicity tests, there are reports of negative in almost all bacterial mutation tests (including Ames tests) (IARC 79 (2001), EHC 158 (1994)), a negative mouse lymphoma L5178Y gene mutation test (IARC 79 (2001)), a partially positive Syrian hamster embryo cell gene mutation test (IARC 79 (2001)), negative chromosomal aberration tests using Chinese hamster V79 cells and human lymphocytes (IARC 79 (2001)), and a positive Syrian hamster embryo cell transformation tests (IARC 79 (2001), EHC 158 (1994)).
6 Carcinogenicity Not classified - - - - Although a number of assessment documents classified the substance in different categories, it was classified as "Not classified" in accordance with the latest classification of "Group 3" in IARC (IARC (2001). There was no significant increase in the incidence of tumours in a long-term oral test in rats (DFGOT vol. 4 (1992)), however, in other tests the incidences of tumours in the thyroid, liver and pituitary were increased (DFGOT vol. 4 (1992), IARC 7 (1974)). In an epidemiological test, tumours were recorded for the group exposed to amitrol (DFGOT vol. 4 (1992)), however, the IARC working group (IARC 7 (1974)) considered the results of this test to be inconclusive (DFGOT vol. 4 (1992)).
7 Reproductive toxicity Category 2 Warning H361: Suspected of damaging fertility or the unborn child P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ...
For the substance, in a rat one-generation test, pup mortality after weaning was increased (DFGOT vol. 18 (2002)). In a rat two-generation test, changes in the mating and reproductive parameters were observed (JMPR 926 (1997)). In mouse developmental toxicity tests, the incidence of resorptions was increased (DFGOT vol. 18 (2002)) and the incidence of fetal death was increased (JMPR 926 (1997)). In rabbit developmental toxicity tests, increase in the incidence of abortions and fetal morphological alterations such as anophthalmia and microphthalmia were observed (JMPR 856 (1997)). At these dose levels, parental general toxicity such as decreased body weight gain and organ weight change was observed. Based on the results, the substance was classified into Category 2.
8 Specific target organ toxicity - Single exposure Classification not possible - - - - Toxic effects were not observed in rats following inhalation exposure (439 mg/m3/4h) (ACGIH (2001)). In humans, effects on the lung and nervous systems are reported following oral or inhalation exposure to mixtures containing the substance (EHC 158 (1994), IARC 79 (2001)). Thiosyanate is suggested to be a cause (IARC 79 (2001)), however, involvement of the substance is not denied. Based on the available data, classification was not possible due to lack of data.
9 Specific target organ toxicity - Repeated exposure Category 1 (thyroid), Category 2 (liver) Danger
Warning
H372: Cause damage to organs through prolonged or repeated exposure (thyroid)
H373: May cause damage to organs through prolonged or repeated exposure (liver)
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P314: Get medical advice/attention if you feel unwell.
P501: Dispose of contents/container to ...
In repeated oral dose tests in rats, hypertrophy and hyperplasia of the thyroid and goiter were observed at 0.5 - 15 mg/kg (90-day equivalents) (EHC 158 (1994), IARC 79 (2001), DFGOT vol. 18 (2002), JMPR 280 (1974), ACGIH (2001)). In addition, at a dose level of 35 mg/kg (90-day equivalence), vacuolization of the liver cells and steatosis were observed (EHC 158 (1994)). Based on the data and the guidance value ranges, the substance was classified into Category 1 (thyroid gland) and Category 2 (liver). (Above mentioned values of 0.5 mg/kg/day, 15 mg/kg/day and 35 mg/kg/day for rat tests were calculated from dietary concentration/treatment periods of 10 ppm/11 - 13 weeks, 316 ppm/100 days and 1000 ppm/63 days, respectively).
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 2 - - H401: Toxic to aquatic life P273: Avoid release to the environment.
P501: Dispose of contents/container to ...
Classified into Category 2 from its 48h-EC50 = 1.54 mg/L for Crustacea (Daphnia magna) (EHC 158, 1994).
11 Hazardous to the aquatic environment (Long-term) Category 2 - H411: Toxic to aquatic life with long lasting effects P273: Avoid release to the environment.
P391: Collect spillage.
P501: Dispose of contents/container to ...
Classified into Category 2 since its acute toxicity is Category 2 and it is not rapidly degradable (BOD degradation rate: 0% (Biodegradation and Bioconcentration of Chemical Substances under the Chemical Substances Control Law, 1989)).
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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