GHS Classification Result (Revision of the past classification result)

Chemical Name:2,3-Epoxy-1-propanol
CAS:556-52-5

Result:
ID: 21B3086
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 - - - - 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 Category 4 - Warning H227: Combustible liquid P370+P378: In case of fire: Use ... for extinction.
P403+P235: Store in a well-ventilated place. Keep cool.
P210: Keep away from heat/sparks/open flames/hot surfaces. - No smoking.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P501: Dispose of contents/container to ...
Classified into Category 4 (GHS criteria: flash point >60 degC and <=93 degC) from flash point 72 degC (closed-cup) (ICSC (J) 2005)).
7 Flammable solids Not applicable - - - - Liquid (GHS definition)
8 Self-reactive substances and mixtures Classification not possible - - - - Classification is not possible since no data are available though it is known that the substance contains stained ring (epoxides) and causes extremely violent polymerization reaction on contact with metal salts (Hommel (1996)).
9 Pyrophoric liquids Not classified - - - - Auto-ignition point is 415 degC (ICSC (J) (2005), Ullmanns (E) (6th, 2003), Hommel (1996)) exceeding 70 degC.
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 - - - - The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.
14 Oxidizing solids Not applicable - - - - Liquid (GHS definition)
15 Organic peroxides Not applicable - - - - Organic compounds containing no bivalent -O-O- structure in the molecule
16 Corrosive to metals Classification not possible - - - - No data available. High quality steel, aluminum, glass and enamel have a durability as containers (Hommel (1996)).

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 LD50 values of 850 mg/kg, 760 mg/kg (male), 640 mg/kg (female) (PATTY (5th, 2001) and 550 mg/kg (DFGOT vol. 20 (2003)) for rats, the substance was classified into Category 4.
1 Acute toxicity (Dermal) Category 4 Warning H312: Harmful 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).
P363: Wash contaminated clothing before reuse.
P501: Dispose of contents/container to ...
Based on a LD50 value of 1980 mg/kg for rabbits (ACGIH (2001)), the substance was classified into Category 4.
1 Acute toxicity (Inhalation: Gases) Not applicable - - - - Liquid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Category 3 Danger H331: Toxic if inhaled 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.
P311: Call a POISON CENTER or doctor/physician.
P321: Specific treatment (see ... on this label).
P405: Store locked up.
P501: Dispose of contents/container to ...
Based on LC50 values of 580 ppm/8h (820 ppm/4h) (ACGIH (2001)) and 500 ppm/8h (707 ppm/4h) (DFGOT vol. 20 (2003)) for rats, the substance was classified into Category 3. Since the LC50 value was lower than 90% of saturated vapour pressure concentration (1188 ppm), the classification criteria for gas (ppm) was adopted.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible - - - - No data available.
2 Skin corrosion/irritation Category 2 Warning H315: Causes skin irritation P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P332+P313: If skin irritation occurs: Get medical advice/attention.
P264: Wash ... thoroughly after handling.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P321: Specific treatment (see ... on this label).
P362: Take off contaminated clothing and wash before reuse.
Based on results of "moderately irritating" (ACGIH (2001), PATTY (5th, 2001)) and irritation score of 4.5 (maximal value: 8.0) (PATTY (5th, 2001)) in a rabbit test, the substance was classified into Category 2. In EU classification, the substance is classified into Xi; R36/37/38 (EU-Annex I (access on May 2009)).
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.
Based on a report of severe but reversible corneal disorder following application to rabbit eyes (ACGIH (2001), PATTY (5th, 2001)), the substance was classified into Category 2A. In EU classification, the substance is classified into Xi; R36/37/38 (EU-Annex I (access on May 2009)).
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Classification not possible - - - - No data available.
5 Germ cell mutagenicity Category 2 Warning H341: Suspected of causing genetic defects 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 ...
Based on positive results in a bone marrow micronucleus test by intraperitoneal administration to mice and a chromosomal aberration test by intraperitoneal administration to rats and mice (in vivo somatic cell mutagenicity tests) (DFGOT vol. 20 (2003)), the substance was classified into Category 2. As relevant information, from in vitro mutagenicity tests, there are reports of a positive Ames test, a positive mouse lymphoma test, and positive CHO cell and human lymphocyte chromosomal aberration tests (DFGOT vol. 20 (2003), ACGIH (2001)).
6 Carcinogenicity Category 1B Danger H350: May cause cancer 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 ...
Based on the classifications of "2A" in IARC (IARC vol.77 (2000)), "2A" in Japan Society For Occupational Health (JSOH) (Recommendations for allowable concentrations (2008)) and "Category 2" in EU classification (EU-Annex I (access on May 2009)), the substance was classified into Category 1B. In a 103-week oral test in rats, the incidences of gliomas of the brain and forestomach tumours were increased in both sexes. The incidence of mesotheliomas of the tunica vaginalis/peritoneum, and tumours in the intestine, Skin thyroid, and Zymbal gland were increased in male rats, and the incidences of tumours of the clitoral gland, mammary gland, oral mucosa and leukaemia were increased in female rats. In a 103-week oral test in mice, the incidence of Harderian gland tumours was increased in both sexes, and increased incidences of tumours of the forestomach, lung, liver and skin in males, the mammary gland and subcutis in females were observed (IARC vol. 77 (2000)). In a 104-week inhalation test in rats, the incidences of nasal cavity tumor and peritoneal tumor were significantly increased in males, and the incidences of nasal cavity tumor and uterine tumor were increased in female. The results are considered to be clear evidence of carcinogenic activity of 2,3-Epoxy-1-propanol for male and female F344/DuCrlj (Fischer) rats. In a mouse test, the incidences of nasal cavity tumor, subcutaneous tissue tumor and peripheral nervous system tumor were increased in males, and the incidences of nasal cavity tumor, uterine tumor and mammary gland tumor were increased in females. The results are considered to be clear evidence of carcinogenic activity of 2,3-Epoxy-1-propanol for male and female Crj/BDF1 mice (Results from Carcinogenicity tests (Ministry of Health, Labour and Welfare) (2002)). The Ministry of Health, Labour and Welfare has made a public announcement on guidelines in order to prevent the impairment of worker's health based on Industrial Safety and Health Act Article 28-3 (2006).
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 ...
Since in a mouse test (route not stated), resorptions and fetal deaths and anomalies were increased at a maximum tolerated dose for parent animals (IARC 77 (2000)), the substance was classified into Category 2. Injections of the substance into the amniotic cavity of pregnant rats on day 13 of gestation resulted in embryonal deaths and to a significant increase in the incidence of malformations of the fore and hind limbs (DFGOT vol. 20 (2003)). This result was not used as the basis for the determination of classification since the exposure level is considered to be much higher than that expected by conventional exposure routes.
8 Specific target organ toxicity - Single exposure Category 1 (central nervous system, respiratory system) Danger H370: Causes damage to organs (central nervous system, respiratory system) P307+P311: IF exposed: Call a POISON CENTER or doctor/physician.
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.
P321: Specific treatment (see ... on this label).
P405: Store locked up.
P501: Dispose of contents/container to ...
In acute oral toxicity tests in rats and mice (LD50 values: 850 mg/kg for rats, 450 mg/kg for mice), symptoms of intoxication were initial depression of the CNS followed by hypersensitivity to sound with muscular tremors and facial muscular fibrillation. Some rats showed terminal convulsions (PATTY (5th, 2001)). In an acute dermal toxicity test in rabbits (LD50 value: 1980 mg/kg) and acute inhalation tests in rats and mice (vapour, LC50 values (4-hour equivalence): 1.36 - 1.78 mg/L), effects on the central nervous system were reported (DFGOT vol. 20 (2003), PATTY (5th, 2001)). Additionally, by inhalation, lung irritation, pneumonia and emphysema were also detected (PATTY (5th, 2001), ACGIH (2001)). Since these adverse effects are estimated to occur near or below the LD50 value (LC50 value) and the inhalation LC50 value is within the guidance value range for Category 1, the substance was classified into Category 1 (central nervous system, respiratory system).
9 Specific target organ toxicity - Repeated exposure Category 2 (central nervous system, spleen, testis) Warning H373: May cause damage to organs through prolonged or repeated exposure (central nervous system, spleen, testis) 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 tests with rats and mice (NTP TR374 (1990)) and a 16-day oral test with mice (NTP TR374 (1990)), demyelination in the medulla of the brain (both species) and necrosis of the cerebellum (rat only) were observed. One of these findings occurred at a dose level of 300 mg/kg/day (90-day equivalence: 53.3 mg/kg/day) in the 16-day oral test with mice. In the 13-week oral tests with rats and mice (NTP TR374 (1990)), a 40-week oral test in mice (NTP GMM-13 (2007)) and a 16-day oral test with rats (NTP TR374 (1990)), degeneration of the epididymal stroma, atrophy of the testis, granulomatous inflammation of the epididymis occurred and sperm count and sperm motility were reduced. These effects were observed at dose levels of 100 mg/kg/day and higher in the 13-week test with rats, and 19 mg/kg/day and higher concentrations in the 13-week test with mice. In a 2-year oral test with rats (37.5 - 75 mg/kg/day), fibrillation in the spleen was observed in both sexes (NTP TR374 (1990)). As above, since the adverse effects were observed at dose levels within the guidance value range for Category 2, the substance was classified into Category 2 (central nervous system, testis, spleen). As target organs, the liver was excluded and the testis was included due to priority modification of the documents and data addition.
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 ...
Classified into Category 3 from its 96h-EC50 = 53310 microg/L for algae (Pseudokirchneriella subcapitata) (AQUIRE, 2010).
11 Hazardous to the aquatic environment (Long-term) Not classified - - - - Classified into Not classified since it is rapidly degradable (BOD degradation rate: 85% (Biodegradation and Bioconcentration of Existing Chemical Substances under the Chemical Substances Control Law, 2002)) and low bioaccumulative potential is estimated (log Kow = -0.95 (PHYSPROP Database, 2009)).
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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