GHS Classification Result

Chemical Name:3-aminomethyl-3,5,5-trimethylcyclohexylamine
CAS:2855-13-2

Result:
ID: 20A2064
Classifier: Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
Year Classified: FY2008
Reference Manual: GHS Classification Guidance by the Japanese Government (Sep, 2008)

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 - - - - Liquid (GHS definition)
3 Aerosols Not applicable - - - - Not aerosol products.
4 Oxidizing gases Not applicable - - - - Liquid (GHS definition)
5 Gases under pressure Not applicable - - - - Liquid (GHS definition)
6 Flammable liquids Not classified - - - - Since its flash point is 117degC (IUCLID (2000)), the substance was classified into "Not classified".
7 Flammable solid Not applicable - - - - Liquid (GHS definition)
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 classified - - - - Its autoignition point is 380degC (SIDS (2008)), which is > 70degC.
10 Pyrophoric solids Not applicable - - - - Liquid (GHS definition)
11 Self-heating substances and mixtures Classification not possible - - - - Test methods applicable to liquid 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 - - - - Organic compounds containing no oxygen, fluorine or chlorine
14 Oxidizing solids Not applicable - - - - Liquid (GHS definition)
15 Organic peroxides Not applicable - - - - Organic compounds containing no bivalent -O-O- structure
16 Corrosive to metals Classification not possible - - - - No data available.

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 of 1030mg/kg (SIDS (accessed July 2008)), the substance was classified into Category 4.
1 Acute toxicity (Dermal) Classification not possible - - - - No data available.
1 Acute toxicity (Inhalation: Gases) Not applicable - - - - Liquid (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 Category 1 Danger H314: Causes severe skin burns and eye damage P301+P330+P331: IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
P303+P361+P353: IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing. Rinse skin with water/shower.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P264: Wash ... thoroughly after handling.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P310: Immediately call a POISON CENTER or doctor/physician.
P321: Specific treatment (see ... on this label).
P363: Wash contaminated clothing before reuse.
P405: Store locked up.
P501: Dispose of contents/container to ...
In the tests using rabbits and rats, the substance induced edemas and caused irritation and inflammation (SIDS (accessed in July 2008). In addition, its pH is 11.6 (8.5g/L, 20degC). Based on the information, the substance was classified into Category 1. Repeated exposure resulted in severe effects with incrustation and necrosis, and the substance has been classified into R34 in the EU classification (EU-Annex (accessed in July 2008)).
3 Serious eye damage/eye irritation Category 1 Danger H318: Causes serious eye damage P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P310: Immediately call a POISON CENTER or doctor/physician.
Application of the substance into the eyes of rabbits immediately caused severe damage, and necrosis in the conjunctivas was observed 24 hours after the application, leading to the conclusion that the substance was corrosive (SIDS (accessed July 2008)). Thus, the substance was classified into Category 1. Since the substance was corrosive, the test was conducted with only one animal and it was terminated 24 hours after the application.
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 ...
Positive results were obtained from several maximization tests using guinea pigs (including tests that were compliant with OECD Guidelines 406) (SIDS (accessed July 2008)). Furthermore, in humans, there have been many cases of positive reactions documented in case reports and epidemiological studies. In such documentation, humans who developed allergic contact dermatitis after undergoing occupational exposure tested positive in patch tests against this substance (SIDS (accessed July 2008)). Based on these facts, the substance was classified into Category 1.
5 Germ cell mutagenicity Not classified - - - - The substance was classified into "Not classified" based on negative results obtained from micronucleus tests using erythrocytes of mice that underwent oral administration (in vivo mutagenicity tests using somatic cells) (SIDS (accessed July 2008)). In addition, negative results have been documented in in vitro tests such as Ames tests, HGPRT tests, and chromosomal aberration tests (SIDS (accessed July 2008)).
6 Carcinogenicity Classification not possible - - - - No data available.
7 Reproductive toxicity Classification not possible - - - - In the tests using rats that were orally administered during the gestation period including an organogenetic period, while body weight and quantity of food consumption were significantly lower in maternal animals exposed to high doses, no adverse effects, such as teratogenicity and fetal toxicity, were observed on the development of offspring (SIDS (accessed July 2008)). However, there was no data available on the sexual functions and fertility of parental animals, and thus, classification is not possible.
8 Specific target organ toxicity - Single exposure Classification not possible - - - - In acute oral route toxicity tests using rats, it is documented that some of the animals showed increased kidney weight and urine proteins, and that the kidney was the possible target organ (SIDS (accessed July 2008)). However, these documents do not provide information on doses that induced these symptoms and the severity of its toxicity. Thus, classification is not possible.
9 Specific target organ toxicity - Repeated exposure Category 2 (respiratory system) Warning H373: May cause damage to organs through prolonged or repeated exposure (respiratory system) P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P314: Get medical advice/attention if you feel unwell.
P501: Dispose of contents/container to ...
In 13-week oral route exposure tests using rats (OECD Guidelines 408), morphological changes such as an increased incidence in tubular basophilia and tubular casts along with a higher incidence of lymphoid foci were observed at the exposure dose of 160mg/kg/day, indicating nephrosis (SIDS (accessed in July 2008)). However, at the lower exposure dose of 60mg/kg/day, neither effects of the substance nor significant changes were observed. Consequently, this data cannot be used as a basis for classification. On the other hand, in 14-day inhalation exposure tests using rats, dose-dependent, histopathological changes were observed in nasal cavities, respirator tracts, larynx, and lungs at 18-550mg/m3 on day 9 after the application. Specifically, these changes were degeneration and necrosis of the olfactory epithelium and respiratory epithelium, hyperplasia/squamous metaplasia was detected in the nose and larynx, and hypertrophy/ hyperplasia was detected in the trachea and lungs; and the respiratory system was documented to be a target organ (SIDS (accessed in July 2008)). Since 14-day exposure concentrations were 18-550mg/m3 (90-day correction: 0.003-0.086mg/L) and saturated vapour concentration of the substance was 137mg/m3 (19.7 ppm), it was determined that these symptoms occurred under the mist state with application doses that fall within the range of Category 2 doses. Thus, the substance was classified into Category 2 (respiratory system).
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 3 - - H402: Harmful to aquatic life P273: Avoid release to the environment.
P501: Dispose of contents/container to ...
Since its 48-hour EC50 = 23mg/L for crustaceans (Daphnia magna) (SIDS, 2005), the substance was classified into Category 3.
11 Hazardous to the aquatic environment (Long-term) Not classified - - - - Since its classification for acute toxicity is Category 3, it is not rapidly degradable (non-biodegradable, BOD degradability: 0% (Biodegradation and Bioconcentration of Existing Chemical Substances under the Chemical Substances Control Law, 1986)), and its 21-day NOEC = 3.0mg/L (> 1mg/L) (SIDS, 2005), the substance was classified into "Not classified".


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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