NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	106-89-8
Chemical Name	Epichlorohydrin
Substance ID	m-nite-106-89-8_v1
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	To Guidance List
UN GHS document (External link)	To UN GHS document
FAQ（GHS classification results by the Japanese Government）	To FAQ
List of Information Sources (Excel file)	List of Information Sources
List of Definitions/Abbreviations	Definitions/Abbreviations
Sample Label by MHLW (External link)	To Workplace Safety Site (MHLW)
Sample SDS by MHLW (External link)	To Workplace Safety Site (MHLW)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecules.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
6	Flammable liquids	Category 3	Warning	H226	P303+P361+P353 P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501	Classified into Category 3 since flash point 31 degC (closed-cup) (ICSC (2003)) is >=23 degC and <=60 degC.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
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.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
9	Pyrophoric liquids	Not classified	- -	-	-	Auto-ignition point is 385 degC (ICSC (2003), IUCLID (2000)) and 411 degC (NFPA (13th, 2002)) exceeding 70 degC.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (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).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	The substance is an organic compound containing chlorine and oxygen (but not fluorine) which are chemically bonded only to carbon or hydrogen.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
17	Desensitized explosives	-	- -	-	-	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Acute toxicity (Oral)	Category 3	Danger	H301	P301+P310 P264 P270 P321 P330 P405 P501	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	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Dermal)	Category 3	Danger	H311	P302+P352 P361+P364 P280 P312 P321 P405 P501	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.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Inhalation: Vapours)	Category 2	Danger	H330	P304+P340 P403+P233 P260 P271 P284 P310 P320 P405 P501	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.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
2	Skin corrosion/irritation	Category 1	Danger	H314	P301+P330+P331 P303+P361+P353 P305+P351+P338 P304+P340 P260 P264 P280 P310 P321 P363 P405 P501	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.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	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.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
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.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	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)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
5	Germ cell mutagenicity	Category 2	Warning	H341	P308+P313 P201 P202 P280 P405 P501	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)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
6	Carcinogenicity	Category 1B	Danger	H350	P308+P313 P201 P202 P280 P405 P501	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)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	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)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
8	Specific target organ toxicity - Single exposure	Category 1 (respiratory system, liver, kidney)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	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).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
9	Specific target organ toxicity - Repeated exposure	Category 1 (respiratory system, kidney)	Danger	H372	P260 P264 P270 P314 P501	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.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
11	Hazardous to the aquatic environment Short term (Acute)	Category 3	- -	H402	P273 P501	From 96-hour LC50 = 10.6 mg/L for fish (Pimephales promelas) (Result of the initial environmental risk assessment of chemicals, Vol. 1, Ministry of the Environment in Japan, 2002; Initial Risk Assessment Report, NITE, 2007), it was classified in Category 3.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	If chronic toxicity data are used, then it is classified as "Not classified" due to rapid degradability (a degradation rate after 48 hours: 75% (OECD TG301A) (SIDS, 2009)), and 72-hour NOEC = 1.7 mg/L for algae (Pseudokirchneriella subcapitata) (SIDS, 2009). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified as "Not classified" due to rapid degradability (a degradation rate after 48 hours: 75% (OECD TG301A) (SIDS, 2009)), and a low bioaccumulation estimate (log Kow = 0.45 (PHYSPROP Database, 2009)), despite 96-hour LC50 = 10.6 mg/L for fish (Pimephales promelas) (Result of the initial environmental risk assessment of chemicals, Vol. 1, Ministry of the Environment in Japan, 2002; Initial Risk Assessment Report, NITE, 2007). It was classified as "Not classified" from the above results.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in Annexes to the Montreal Protocol.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))

NOTE:

GHS Classification Result by the Japanese Government is intended to provide a reference for preparing a GHS label or SDS for users. To include the same classification result in a label or SDS for Japan is NOT mandatory.
Users can cite or copy this classification result when preparing a GHS label or SDS. Please be aware, however, that the responsibility for a label or SDS prepared by citing or copying this classification result lies with users.
This GHS classification was conducted based on the information sources and the guidance for classification and judgement which are described in the GHS Classification Guidance for the Japanese Government etc. Using other literature, test results etc. as evidence and including different content from this classification result in a label or SDS are allowed.
Hazard statement and precautionary statement will show by hovering the mouse cursor over a code in the column of "Hazard statement" and "Precautionary statement," respectively. In the excel file, both the codes and statements are provided.
A blank or "-" in the column of "Classification" denotes that a classification for the hazard class was not conducted in the year.
An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

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