NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	105-60-2
Chemical Name	epsilon-Caprolactam
Substance ID	m-nite-105-60-2_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)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
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 molecule.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Classification not possible	- -	-	-	It is described that it is combustible (ICSC (J) (2009)), but the classification is not possible due to no data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 375 deg C (GESTIS (Access on June 2017)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to substance (melting point <= 140 deg C) substances are not available.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified	- -	-	-	It is estimated that it does not react vigorously with water from the measurement result of water solubility of 4,650 g/L (20 deg C) (GESTIS (Access on June 2017)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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 4	Warning	H302	P301+P312 P264 P270 P330 P501	Based on reported LD50 values for rats of 1,475 mg/kg (female), 1,876 mg/kg (male) (both SIDS (2003)), it was classified in Category 4.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Category 4	Warning	H312	P302+P352 P362+P364 P280 P312 P321 P501	Based on a reported LD50 value of 1,410 mg/kg (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)) for rabbits, it was classified in Category 4.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Not classified	- -	-	-	Based on reported LC50 values of 8.14 mg/L (ACGIH (7th, 2003)) and 8.16 mg/L (SIDS (2003)) in a 4-hour inhalation exposure test of the aerosol with rats, it was classified as "Not classified."	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	Based on a description that this substance is a skin irritant (DFGOT Vol. 4 (1992)), and a report that it is slightly irritating in a skin irritation test with rabbits (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)), it was classified in Category 2. Besides, this substance was classified as "Skin Irrit. 2" in EU CLP classification (ECHA CL Inventory (Access on June 2017)). Based on the information obtained in this investigation, the category was revised.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Category 2	Warning	H319	P305+P351+P338 P337+P313 P264 P280	Since there is a report that it showed moderate irritation in an eye irritation test with rabbits (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)), and there is no information on the recovery period, it was classified in Category 2. Besides, this substance was classified as Eye Irrit. 2 in EU CLP classification (ECHA CL Inventory (Access on June 2017)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Not classified	- -	-	-	Based on a description that no response showing sensitization was observed in a sensitization test with humans (SIDS (2003)) and a report that both of two sensitization tests with guinea pigs were negative (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)), it was classified as "Not classified."	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	The substance was classified as "Classification not possible" because it was not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese government. As for in vivo, a mouse spot test gave an ambiguous result, a micronucleus test and a chromosomal aberration test with mouse bone marrow cells were negative, a sister chromatid exchange test with bone marrow cells of mice was negative, a DNA damage test with liver cells of rats and an unscheduled DNA synthesis test with liver cells and spermatocytes of rats were negative (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), Environmental Risk Assessment for Chemical Substances Vol.3 (Ministry of the Environment, 2004), SIDS (2003), IARC 71 (1999), DFGOT Vol. 4 (1992), ACGIH (7th, 2003)). As for in vitro, a bacterial reverse mutation test, a gene mutation test, a mouse lymphoma test, a micronucleus test, a chromosomal aberration test, and a sister chromatid exchange test with mammalian cultured cells were negative (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), Environmental Risk Assessment for Chemical Substances Vol.3 (Ministry of the Environment, 2004), SIDS (2003), IARC 71 (1999), DFGOT Vol. 4 (1992), ACGIH (7th, 2003)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Not classified	- -	-	-	In 2-year carcinogenicity studies with rats and mice dosed by feeding, no increase in the incidence of tumors related to administration was observed in males or females of either species even at the doses where decreased body weight gain was observed (NTP TR214 (1982), IARC 71 (1999)). In addition, as for multi-step carcinogenicity studies with male rats, in two tests in which 10,000 ppm of this substance was administered by feeding for 16 or 6 weeks after pretreatment with known carcinogens (initiator), there was no change in the number and size of GST positive foci of the liver, and the results were negative (IARC 71 (1999)). As classification results by other organizations, IARC classified it in Group 4 (IARC 71 (1999)), and ACGIH in A5 (ACGIH (7th, 2003)), therefore, it was classified as "Not classified" for this hazard class.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	No reproductive toxicity effect was observed in any generation in two 3-generation reproductive toxicity studies with rats dosed by feeding (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), SIDS (2003), Environmental Risk Assessment for Chemical Substances Vol.3 (Ministry of the Environment, 2004), ACGIH (7th, 2003)). On the other hand, among developmental toxicity tests with pregnant rats or pregnant rabbits dosed by gavage, in a test with rabbits, only slight effects (a low value of fetus body weight, extra ribs) were observed even at up to doses of 150-250 mg/kg/day where maternal toxicity (decreased body weight gain) was observed but in a test with rats, an increase in fetal mortality and an increase in resorptions were observed at 1,000 mg/kg/day where decreased body weight gain occurred in maternal animals (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), SIDS (2003), Environmental Risk Assessment for Chemical Substances Vol.3 (Ministry of the Environment, 2004), ACGIH (7th, 2003)). In addition, in a test with pregnant rats exposed by inhalation during early pregnancy or the organogenesis period, although it is unknown whether general toxicity was observed in maternal animals or not, an increase in resorptions, a decrease in the fertility index, and a decrease in body weight at birth at or above 140 mg/m3, and an increase in fetal mortality, a delay of the gestational period, and a decrease in litter size at 475 mg/m3 were observed (Environmental Risk Assessment for Chemical Substances Vol.3 (Ministry of the Environment, 2004), Khadzhieva, E.D., Hyg. Sanit., 34, 28-31 (1969)). From the above, in developmental toxicity tests with rats by the oral and inhalation routes, at doses of maternal toxicity or at doses where maternal toxicity is unknown, an increase in deaths of embryos/fetuses was observed, and in addition, effects on fertility (a decrease in the fertility index, a decrease in litter size) were found in the inhalation route, therefore, it was classified in Category 2.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Category 2 (nervous system), Category 3 (respiratory tract irritation)	Warning	H371 H335	P308+P311 P260 P264 P270 P405 P501 P304+P340 P403+P233 P261 P271 P312	As for humans, there is a report that in an inhalation exposure at 68 mg/m3, an irritation effect on the sensory nerve was observed, and it is described that it is irritating to the respiratory tract (SIDS (2003)). As for experimental animals, there is a report that in a single oral dose test with rats, although there is no description of the doses, clonic convulsions were observed (SIDS (2003)). As LD50 values in this study were reported to be 1,475 mg/kg in females, and 1,875 mg/kg in males, the symptoms are considered to be observed at doses in the range of Category 2 near the LD50 values. In addition, there is a report that in a single oral dose test with rabbits, at 1,000 mg/kg, muscle twitching, opisthotonus and intense muscle cramps were observed, and all the animals died, and in a single oral dose test with cats, at 1,000 mg/kg, excitement, salivation, and repetitive severe muscle cramps were caused and the cats died after 2 hours (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)). For the inhalation route, there is a report that in a 4-hour aerosol inhalation exposure test with rats, the main symptoms were closed eyes, piloerection, and irregular breathing (SIDS (2003)). Although there is no description of the dose at which the symptoms were observed, it is considered to exceed the range for Category 2 near 8.1 mg/L of the LC50 value. From the above, it was classified in Category 2 (nervous system), Category 3 (respiratory tract irritation). Since Hazard Assessment Report (CERI, NITE) used in the previous classification is the information source listed as List 3 in the current GHS classification guidance for the Japanese government, it was not adopted. Therefore, the classification result was changed.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Category 1 (respiratory organs)	Danger	H372	P260 P264 P270 P314 P501	As for humans, there is a report that although exposure concentrations are unknown, six cases were reported which had respiratory organs damages related to exposure to the mist which was released from nylon 6 processing machinery in which this substance was used as a raw material, after irritation of the eye, nose, and upper respiratory tract, respiratory organs lesions containing symptoms of bronchus hyperreactivity, asthmatic reactions, and decreased lung function were observed, and this substance is considered to be a causal substance (Environmental Risk Assessment for Chemical Substances Vol.3 (Ministry of the Environment, 2004)). As for experimental animals, in a 13-week toxicity test (6 hours/day, 5 days/week) in which rats were exposed by inhalation to the aerosol, at or above 70 mg/m3 (converted guidance value: 0.05 mg/L) within the guidance value range for Category 2, moderate hypertrophy and hyperplasia in the goblet cells of the nasoturbinal mucosa, accumulation of eosinophilic material in the mucosal epithelial cells, slight squamous metaplasia and hyperplasia in the pharyngeal region ventral epithelium were observed, and at 243 mg/m3 (converted guidance value: 0.18 mg/L), keratinization of the metaplastic epithelium in the pharyngeal region ventral epithelium was observed (Environmental Risk Assessment for Chemical Substances Vol.3 (Ministry of the Environment, 2004), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), SIDS (2003)). Other than these, as for the oral route, multiple repeated oral toxicity tests with rats or mice dosed by feeding for 13 weeks to two years were performed, and in some cases, renal lesions (hyaline degeneration in the renal tubules) which are specific to male rats were observed at a dose within the guidance value range for Category 2, but no effects which are available for evidence of the classification were observed. From the above, it was classified in Category 1 (respiratory organs).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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)	Not classified	- -	-	-	From 72-hour EC50 >1,000 mg/L for algae (Pseudokirchneriella subcapitata) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2017)), 48-hour EC50 >500 mg/L for crustacea (Daphnia magna) (OECD SIDS:2001), and 96-hour LC50 >100 mg/L for fish (Oryzias latipes) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2017), Environmental Risk Assessment for Chemical Substances vol. 3 (Ministry of the Environment, 2004), Initial Risk Assessment (NITE, CERI, NEDO, 2007)), it was classified as "Not classified."	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	Due to being rapidly degradable (readily biodegradable, a degradation rate by BOD: 82% (J-CHECK, 1983)), no bioaccumulation (LogKow: -0.19 (Environmental Risk Assessment for Chemical Substances vol. 3 (Ministry of the Environment, 2004))), 72-hour NOEC (rate method) = 1,000 mg/L for algae (Pseudokirchneriella subcapitata) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2017)), and 21-day NOEC (reproduction inhibition) = 100 mg/L for crustacea (Daphnia magna) (Environmental Risk Assessment for Chemical Substances vol. 3 (Ministry of the Environment, 2004)), it was classified as "Not classified."	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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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