GHS Classification Result (Revision of the past classification result)

Chemical Name:Epichlorohydrin
CAS:106-89-8

Result:
ID: 21B3085
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 3 Warning H226: Flammable liquid and vapour P303+P361+P353: IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing. Rinse skin with water/shower.
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.
P233: Keep container tightly closed.
P240: Ground/bond container and receiving equipment.
P241: Use explosion-proof electrical/ventilating/lighting/.../equipment.
P242: Use only non-sparking tools.
P243: Take precautionary measures against static discharge.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P501: Dispose of contents/container to ...
Classified into Category 3 since flash point 31 degC (closed-cup) (ICSC (2003)) is >=23 degC and <=60 degC.
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 the substance contains strained ring in the chemical structure.
9 Pyrophoric liquids Not classified - - - - Auto-ignition point is 385 degC (ICSC (2003), IUCLID (2000)) and 411 degC (NFPA (13th, 2002)) 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 chlorine and oxygen (but not fluorine) which are 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
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 3 Danger H301: Toxic if swallowed P301+P310: IF SWALLOWED: Immediately call a POISON CENTER or doctor/physician.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P321: Specific treatment (see ... on this label).
P330: Rinse mouth.
P405: Store locked up.
P501: Dispose of contents/container to ...
Based on LD50 values of 90 mg/kg (Initial Environmental Risk Assessment of Chemicals (Ministry of Environment) vol. 1 (2002)) and 260 mg/kg (EHC 33 (1984)) for rats, the category with higher hazard was adopted and the substance was classified into Category 3
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 a LD50 value of 591.5 mg/kg for rats (PATTY (5th, 2001), the substance was classified into Category 3. Based on LD50 values of 1300 mg/kg (Initial Environmental Risk Assessment of Chemicals (Ministry of Environment) vol.1 (2002)), 754 mg/kg (EHC 33 (1984)) and 1041 mg/kg for rabbits (PATTY (5th, 2001), the substance was classified into Category 4. The category for rats with higher hazard was adopted and the substance was classified into Category 3.
1 Acute toxicity (Inhalation: Gases) Not applicable - - - - Liquid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Category 2 Danger H330: Fatal 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.
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P271: Use only outdoors or in a well-ventilated area.
P284: Wear respiratory protection.
P310: Immediately call a POISON CENTER or doctor/physician.
P320: Specific treatment is urgent (see ... on this label).
P405: Store locked up.
P501: Dispose of contents/container to ...
LC50 values are 634.2 ppm (EHC 33 (1984)), 251.1 ppm (Initial Environmental Risk Assessment of Chemicals (Ministry of Environment) vol. 1 (2002)) and 500 ppm (PATTY (5th, 2001) for rats. Two values correspond to Category 2 and one value corresponds to Category 3, the substance was classified into Category 2. Since the test concentration was lower than 90% of saturated vapour pressure concentration of the substance (21578.9 ppmV), 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 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 a rabbit skin irritation test, in which a stock solution of the substance was applied for 2 - 24-hour, severe irritation and necrosis were observed (Hazard Assessment Report (CERI, NITE) No. 74 (2004)). In accidental cases of occupational exposure, effects such as skin ulcer, erosion and burns are reported (Hazard Assessment Report (CERI, NITE) No. 74 (2004), ACGIH (7th, 2001)). The substance is classified into C; R34 in EU classification. Based on these information, the substance was classified into Category 1.
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.
In a rabbit eye irritation test (cottonseed oil was used as vehicle), severe irritation accompanied by corneal disorder was observed following application of a 80% solution, and mild irritation was observed following application of a 10% solution (Hazard Assessment Report (CERI, NITE) No. 74 (2008)). Although this data corresponds to Category 2A, the substance is classified into Category 1 for skin irritation, not skin corrosive. Therefore, the substance was classified into Category 1.
4 Respiratory sensitization Classification not possible - - - - In a case report of an accidental massive exposure in humans, chronic asthmatic bronchitis is reported (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment) vol. 1 (2002)). Since this information is not sufficient as evidence for classification, classification was not possible due to lack of other data.
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 ...
There is a report of allergic contact dermatitis in 6 workers who showed dermatitis following occupational exposure (Hazard Assessment Report (CERI, NITE) No. 74 (2008)). In a patch test of epoxy resin factory workers who showed dermatitis, positive response to this substance was observed in 8 of 19 participants (Hazard Assessment Report (CERI, NITE) No. 74 (2008)). In a patch test of contact dermatitis for epoxy resin workers, positive reaction to this substance was observed in 5 workers (duration engaged in work: 1 - 5 years) (ACGIH (7th, 2001)). There is additional information reporting skin sensitizing property of this substance (EHC 33 (1984)). The substance was classified into Category 1. As relevant information, positive results are also reported in a guinea pig maximization test (Hazard Assessment Report (CERI, NITE) No. 74 (2008)).
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 a positive result in a mouse bone marrow chromosomal aberration test (in vivo somatic cell mutagenicity test) (Hazard Assessment Report (CERI, NITE) ver. 1.1 No. 74 (2008), PATTY (5th, 2001)), the substance was classified into Category 2. There is a report of a positive spermatogonium chromosomal aberration test by inhalation exposure to mice (in vivo germ cell mutagenicity test) (Hazard Assessment Report (CERI, NITE) ver. 1.1 No. 74 (2008)), however, the reliability of the data is questionable. A negative result is reported in a mouse dominant lethal test (in vivo heritable germ cell mutagenicity test) (Hazard Assessment Report (CERI, NITE) ver. 1.1 No. 74 (2008)). From in vitro mutagenicity tests, there are reports of a positive Ames test and a positive chromosomal aberration test (Hazard Assessment Report (CERI, NITE) ver. 1.1 No. 74 (2008), NTP DB (2009)).
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 (1999)) and "R" in NTP (NTP (2005)), the substance was classified into Category 1B. In a 2-year oral test in rats, the incidence of hyperplasia, papilloma and carcinoma in the forestomach were significantly increased (IRIS (2008)). In an inhalation test where rats were exposed for 30 days and observed for their lifetime, nasal cavity tumors, including squamous cell carcinomas, developed as compared with none in the control group (IRIS (2008)).
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 ...
Male rats received oral or inhalation exposure to the substance. When the exposed males were mated with untreated females, male infertility was evident. The infertility effect was permanent at higher dose levels (Hazard Assessment Report (CERI, NITE) No. 74 (2008), ACGIH (2001)). Additionally, reduced sperm motility and decreases in the number of fertilized ovum and implantations in mated females were observed (Hazard Assessment Report (CERI, NITE) No. 74 (2008)). When treated females mated with untreated males, no reproductive effects were observed (Hazard Assessment Report (CERI, NITE) No. 74 (2008)). The parental toxicity was not described. Based on male infertility and the decreased number of implantations, the substance was classified into Category 2. In developmental toxicity tests in rats, mice and rabbits, there was no effect on fetal development. In an epidemiological test for male employees engaged in the manufacture of glycerine, there was no detrimental effect on fertility due to exposure to the substance (IARC 71 (1999)).
8 Specific target organ toxicity - Single exposure Category 1 (respiratory system, liver, kidney) Danger H370: Causes damage to organs (respiratory system, liver, kidney) 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 inhalation tests, necrosis and ulceration in the respiratory tract and olfactory epithelium were observed following 6-hour exposure (vapour) of 697 ppm (4-hour equivalent: 3.957 mg/L) in mice (Hazard Assessment Report (CERI, NITE) No. 74 (2008)). Pulmonary edema and hemorrhage were observed following 6-hour exposure (vapour) of 283 - 445 ppm (4-hour equivalent: 1.608 - 1.684 mg/L) in rats (IRIS (2008)). Based on the data, the substance was classified into Category 1 (respiratory system). In oral tests in rats, polyuria, increased kidney weight and changes in urine component were observed at 7 - 350 mg/kg, and renal failure was noted in approximately 80% of animals at 125 mg/kg (Hazard Assessment Report (CERI, NITE) No. 74 (2008)). Nephropathy accompanied by vacuolization is reported at 325 - 500 mg/kg following oral exposure in rats and mice (Hazard Assessment Report (CERI, NITE) No. 74 (2008)). Since adverse effects were noted at dose levels within the guidance value range for Category 1 with the inhalation and oral routes, the substance was classified into Category 1 (kidney). In the oral tests in rats and mice (325 - 500 mg/kg) reported above, fatty degeneration in the liver was also observed (Hazard Assessment Report (CERI, NITE) No. 74 (2008)). There is a case report of an accidental massive systemic exposure, where an enlarged liver with jaundice is reported, and fatty degeneration together with functional disturbances of the liver persisted for more than two years (ACGIIH (2001)). Based on the data, the substance was classified into Category 1 (liver).
9 Specific target organ toxicity - Repeated exposure Category 1 (respiratory system, kidney) Danger H372: Cause damage to organs through prolonged or repeated exposure (respiratory system, kidney) 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 rats, dilation of the renal tubules was observed at 50 ppm (vapour; 0.189 mg/L) following a 13-week inhalation exposure period (Hazard Assessment Report (CERI, NITE) No. 74 (2008)). Focal degeneration of the renal tubules was observed at 50 ppm (0.189 mg/L) following a 10-week inhalation exposure period (Hazard Assessment Report (CERI, NITE) No. 74 (2008)). Degeneration and dilation of the renal tubules were observed at 30 ppm (0.114 mg/L) following a life-time inhalation exposure (IRIS (2008)). Since these findings were noted at dose levels within the guidance value range for Category 1, the substance was classified into Category 1 (kidney). Inflammation, focal erosion, hyperplasia and squamous metaplasia in the turbinate airway epithelium were observed at 25 ppm (0.095 mg/L) and higher concentrations following a 13-week inhalation exposure period in rats and mice (Hazard Assessment Report (CERI, NITE) No. 74 (2008)). Lung disorders, mainly edema, congestion and pneumonia were observed at a dose of 100 ppm (0.378 mg/L, 90-day equivalence: 0126 mg/L) following a 30-day inhalation exposure period in rats (ACGIH (7th, 2001)). Purulent rhinitis, sinusitis and pneumonia were observed at 25 ppm (0.095 mg/L) and higher concentrations following a 10-week inhalation exposure period in rabbits (Hazard Assessment Report (CERI, NITE) No. 74 (2008)). Since these findings were noted at dose levels within the guidance value range for Category 1, the substance was classified into Category 1 (respiratory system). Effects on the heart and central nervous system are reported (Hazard Data Book for Chemical Substance (CERI) 96-48 (1998)) based on a literature published in 1966 (Fomin, A.P.: Gig. Sanit. 31 (9); 7-11). However, toxic effects are not reported in subsequent tests including repeated exposure tests, therefore, the heart and central nervous system are not considered to be target organs.
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-LC50 = 10600 microg/L for fish (Fathead minnow) (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment), Vol. 1, 2002, etc).
11 Hazardous to the aquatic environment (Long-term) Not classified - - - - Classified into Not classified since it is rapidly degradable (BOD degradation rate: 67.9% (Biodegradation and Bioconcentration of Existing Chemical Substances under the Chemical Substances Control Law, 1975)) and low bioaccumulative potential is estimated (log Kow = 0.45 (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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