GHS Classification Result （Revision of the past classification result）

Chemical Name：2-Propanol, 2-methyl-
CAS：75-65-0

Result：
ID: 22B4520
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 - - - - The substance is a solid in GHS definition. As relevant notes, it is reported that "the substance is frequently transported at high temperature since its melting point is low" (Hommel (1996)) in transportation and it is defined as Class 3, PG II, melting point: 25 degC and liquid in UNRTDG (UN1120). From the viewpoint of the experimental data, its flash point 11 degC (closed-cup) (ICSC (J) (1995)) and initial boiling point 83 degC (ICSC (J) (1995)) are < 23 degC and > 35 degC, respectively. If the substance is assumed to be liquid, it will correspond to Category 2.
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 - - - - The substance is a solid in GHS definition. As relevant notes, it is reported that the substance is frequently transported at high temperature since its melting point is low (Hommel (1996)), so the substance is transported in liquid state in transportation, but its autoignition temperature is 470 degC and it is considered that it does not ignite at room temperature.
10 Pyrophoric solids Not classified - - - - Based on the autoignition temperature of 470 degC (ICSC (1995)), it was judged that the substance does not ignite at room temperature and it corresponds to "Not classified".
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 - - - - The substance is a solid in GHS definition. As relevant notes, it is reported that the substance is frequently transported at high temperature since its melting point is low (Hommel (1996)), so the substance is transported in liquid state in transportation.
14 Oxidizing solids Not applicable - - - - The substance is an organic compound containing oxygen which is chemically bonded only to carbon or hydrogen.
15 Organic peroxides Not applicable - - - - Organic compounds containing no bivalent -O-O- structure.
16 Corrosive to metals Classification not possible - - - - No data available. As relevant notes, it is reported that the substance is frequently transported at high temperature since its melting point is low (Hommel (1996)), so the substance is transported in liquid state in transportation. However, based on the report that steel and aluminum are suitable for container (Hommel (1996)), it was determined that it corresponds to "Not classified".

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity （Oral） Not classified - - - - Based on four LD50 values for rats of 2200 mg/kg (DFGOT, 19 (2003)), 3046 mg/kg (Hazard Assessment Report (CERI, NITE) (2007)), 2298 mg/kg (Hazard Assessment Report (CERI, NITE) (2007)) and 3500 mg/kg (ACGIH (2001)), the substance was classified as "Not classified" in the JIS classification (corresponding to Category 5 or "Not classified" in the UN-GHS classification).
1 Acute toxicity （Dermal） Not classified - - - - Based on the rabbit LD50 value of > 2000 mg/kg (Hazard Assessment Report (CERI, NITE) (2007)) and the description that no mortality was observed at 2000 mg/kg on the rabbit study (DFGOT, vol. 19 (2003)), the substance was classified as "Not classified" in the JIS classification (corresponding to Category 5 or "Not classified" in the UN-GHS classification).
1 Acute toxicity （Inhalation: Gases） Not applicable - - - - Solid (GHS definition)
1 Acute toxicity （Inhalation: Vapours） Classification not possible - - - - The rat LC50 value of > 10000 ppm/4hrs (30.3 mg/L/4hrs) (Hazard Assessment Report (CERI, NITE)) was reported. And it was reported that death was observed in one of ten animals at 7060 ppm/4hrs (21.36 mg/L/4hrs) in the rat study (DFGMAK-Doc.19 (2003)). Since both data did not provide the basis for classification, the substance was classified as "Classification not possible". As the test concentration (7060 - 10000 ppm) was lower than 90% of saturated vapor pressure concentration (53553 ppm), the test substance was treated as "vapor hardly coexisting mist" and the criterion values for gas were adopted.
1 Acute toxicity （Inhalation: Dusts and mists） Classification not possible - - - - No data available.
2 Skin corrosion/irritation Not classified - - - - In the rabbit test, application of 0.5 mL of undiluted substance caused no irritation effect after either 2 to 4 hours or 24 hours, and the irritation index was 0.4 (DFGMAK-Doc.19 (2003)). In human cases, application of the substance to five volunteers caused slight erythema and hyperemia (ACGIH (2001)). Based on these documents, the substance was classified as "Not classified" in the JIS classification (corresponding to Category 3 or "Not classified" in the UN-GHS classification).
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. 		In the primary eye irritation test using rabbits (GLP-compliant), instillation of 100 microL of the substance caused severe irritation in non-rinsed eyes and moderate irritation in rinsed eyes after 96 hours of instillation. Corneal injury was persistent after 34 days of instillation in 2 out of 6 animals (Initial Risk Assessment Report (NITE, CERI, NEDO)). In the other rabbit test, instillation of undiluted substance caused moderate irritation for up to 96 hours. The induced corneal damage improved slowly, and severe irritation effect was observed in the animals whose eyes were not rinsed (DFGMAK-Doc.19 (2003)). Based on the information, the substance was classified as Category 2A. The substance was classified as "Xi: R36" in the EU classification (EU-Annex 1 (Access on Jul. 2009)).
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Classification not possible - - - - In the maximization test (OECD TG 406) in guinea pigs, no sensitizing effect was noted (DFGMAK-Doc.19 (2003)). In other maximization test in guinea pigs, positive rate was 25 - 30% (DFGMAK-Doc.19 (2003)), so the substance was not assessed as "positive" (because more than 30% of positive rate (using adjuvant) was considered as "positive" in the GHS guidance). On the other hand, in the human case, erythema and blister were observed in patch test of the 70% solution of the substance to a man who raised extensive pruritic flare and vesicle rash in face, neck, arms and chest after using sunscreen containing the substance (Hazard Assessment Report (CERI, NITE) (2007)). Positive result due to cross-reaction with ethanol was reported (Hazard Assessment Report (CERI, NITE) (2007)), and it was also mentioned that it could not be concluded that the substance had significant sensitizing potential (DFGMAK-Doc.19 (2003)). As mentioned above, there were contradictory reports between animal and human data, and there was no other information for skin sensitization potential to be positive or negative, and therefore the substance was classified as "Classification not possible".
5 Germ cell mutagenicity Not classified - - - - The substance was classified as "Not classified" based on the negative results in the micronucleus test using bone marrow cells of rats intraperitoneally administered and the micronucleus test using peripheral blood from mice administered via drinking water (NTP TR53 (1997)). As relevant information, as for in vitro studies, negative results were reported in the Ames test, chromosome aberration test using CHO cells and gene mutation test using mouse lymphoma cells (Hazard Assessment Report (CERI, NITE) (2007), NTP TR53 (1997)).
6 Carcinogenicity Classification not possible - - - - It was classified as "Classification not possible" based on the criteria of "A4" in the carcinogenicity assessment of the ACGIH (ACGIH (2001)). As relevant information, in the 2-year administration tests via drinking water in rats and mice, no evidence of carcinogenicity in female rats, significant increase in the incidences of adenomas or carcinomas of renal tubules in male rats, slight increase in the incidence of adenomas or carcinomas of thyroid follicular cells in male mice, and significant increase in the incidence of adenomas of thyroid follicular cells in female mice, were reported (NTP DB (Access on Jul. 2009)).
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 ... 		In the oral reproduction/developmental toxicity screening test in rats (OECD TG421), increased gestation length, increased number of stillborn pups, decreased number of live born pups, decreased mean litter size were observed at the dose levels that general toxicity such as increased kidney weight in parental animals was observed (Hazard Assessment Report (CERI, NITE) (2007)). In the feeding study in mice at gestation day 6 - 20, dose-related reductions in the number of litters, and increase in the number of stillborn pups were observed (NTP TR53 (1997)). In addition, in the feeding study in rats administered from gestation day 8 to parturition, litter size was reduced, and perinatal and postnatal mortality increased at the dose levels that reduced body weight gain was observed in dams (DFGMAK-Doc.19 (2003)). Based on these results, the substance was classified as Category 2. In addition, adverse effects on sexual functions and fertility of parental animals, and teratogenicity in development of offspring were not observed (Hazard Assessment Report (CERI, NITE) (2007), DFGMAK-Doc.19 (2003)).
8 Specific target organ toxicity - Single exposure Category 3 （Narcotic effects, Respiratory tract irritation） Warning H335: May cause respiratory irritation (narcotic effects, respiratory tract irritation)
H336: May cause drowsiness or dizziness (narcotic effects, respiratory tract irritation) 		P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P271: Use only outdoors or in a well-ventilated area.
P312: Call a POISON CENTER or doctor/physician if you feel unwell.
P405: Store locked up.
P501: Dispose of contents/container to ... 		The signs of depression of central nervous system were observed in rats after oral administration (4000 or 6000 mg/kg) (ACGIH (2001)), and narcotic effects were seen in rabbits after oral administration or in rats after inhalation exposure (ACGIH (2001), DFGMAK-Doc.19 (2003)), respectively. In addition, it was described that the substance was anesthetic in nature and its inhalation exposure by vapor at high concentrations caused lethargic state (NIOSH Publications 81-123 (1978)). While, it was reported that excessive exposure to the substance could produce irritation in the nose and throat (PATTY, 5th (2001)), and that even in anosmic persons its exposure for about 2 seconds could produce nasal irritation (DFGMAK-Doc.19 (2003)). The result of EU-classification of the substance was "R36/37". Based on the information, the substance was classified as Category 3 (narcotic effects, respiratory tract irritation). Besides, with regard to the hepatic effects, increased liver triacylglycerol concentrations was observed in rats administered orally at 1850 mg/kg (ACGIH (2001)), while, it was reported in another study that no changes in liver triglycerides, cholesterol or phospholipid concentrations could be detected in rats administered orally with the higher doses of 4000 and 6000 mg/kg (ACGIH (2001)). Thus, the information about hepatic effect was not adopted to classify due to lack of consistency between the data with no changes evidenced by histopathology.
9 Specific target organ toxicity - Repeated exposure Classification not possible - - - - As the toxic effects in the 13-week oral (drinking) studies in rats and mice at the lowest dose level of 2.5 mg/mL (rats: 230 - 290 mg/kg/day, mice: 350 - 500 mg/kg/day), the only finding was increased severity of chronic nephropathy observed in male rats only (NTP TOX 53 (1997)). Similarly, in the 13-week inhalation studies with rats and mice, exposure concentration-related increase in the severity of chronic nephropathy was observed only in male rats at the concentrations of 540 ppm (1.64 mg/L) or higher, however, any other toxic effects were not described (NTP TOX 53 (1997)). With regard to nephropathy, since accumulation of hyaline droplet was observed in the kidneys after 13-week oral administration, this was considered to be male rat specific phenomenon and alpha 2 microglobulin related findings, which was not relevant to humans (NTP TOX 53 (1997)). Thus, the finding was not evidenced to classify. The test dose levels described above were beyond the upper limit of Category 2 of the guidance values, and therefore, "Not classified" was applied in both oral and inhalation routes. With regard to dermal application, however, toxic effects were unknown due to the lack of available data, and "Classification not possible" was justified for the classification of the substance in this hazard class. As relevant information, the effects on clinical symptoms, the liver and urinary bladder other than those on the kidney were reported at higher doses beyond the range of the guidance values (NTP TOX 53 (1997)).
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） Not classified - - - - Classified as "Not classified" from its 96h-LC50 = 6410 mg/L for fish (Fathead minnow) (Hazard Assessment Report (CERI, NITE), 2007), 48h-EC50 = 5504 mg/L for crustacea (Daphnia magna) (Hazard Assessment Report (CERI, NITE), 2007) and 72h-ErC50 > 1000 mg/L for algae (Scenedesmus) (Hazard Assessment Report (CERI, NITE), 2007).
11 Hazardous to the aquatic environment （Long-term） Not classified - - - - Classified as "Not classified" since it is not non-water soluble (water solubility = 1000000 mg/L (PHYSPROP Database, 2009)) and its acute toxicity is low.
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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