NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	96-24-2
Chemical Name	3-Chloro-1,2-propanediol
Substance ID	m-nite-96-24-2_v2
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 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	Not classified	- -	-	-	Classified into Not classified since flash point is 145 degC (open-cup) (IUCLID (2000)) is >93 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	Not classified (Not applicable)	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
9	Pyrophoric liquids	Not classified	- -	-	-	Classified into Not classified since it can be judged that auto-ignition point is not available from the information of "No data" (IUCLID (2000)).	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	LD50 values are 150, 125, 152, 195, 250, 50, 58, 172, 116 and 150 mg/kg bw for rats (JECFA (2001), DFGOT vol. 5 (1993)). Since one values (50 mg/kg bw) correspond to Category 2 and other nine values correspond to Category 3, 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 4	Warning	H312	P302+P352 P362+P364 P280 P312 P321 P501	LD50 values of 1057 mg/kg for rats and 1056 mg/kg for rabbits (RTECS (2009), the original literature: National Technical Information Service. (Springfield, VA 22161) Formerly U.S. Clearinghouse for Scientific & Technical Information.) correspond to Category 4.	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	Based on a LC50 value of 88 - 174 ppm/4h for rats (IUCLID (2000)), the substance was classified into Category 2. Since saturated vapour pressure concentration is 4934 ppm, the test was considered to be conducted for vapour with almost no included mists and classification criteria for gas 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	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	Based on rating of "moderate irritation" with grade 4 injury (on a scale of 1 to 10, the most severe injury; grade 10) by injection of undiluted test substance into rabbit cornea (DFGOT vol. 5 (1993)), the substance was classified into Category 2A.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
4	Skin sensitization	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
5	Germ cell mutagenicity	Not classified	- -	-	-	Based on negative results in dominant lethal tests by intraperitoneal or oral administration to mice and oral administration to rats (in vivo heritable germ cell mutagenicity tests) (JECFA (2001)) and negative results in both rat and mouse bone marrow micronucleus tests (in vivo somatic cell mutagenicity tests) (JECFA (2001)), the substance was classified as "Not classified". As relevant information, from in vitro mutagenicity tests, there are reports of a positive Ames test and a positive mouse lymphoma gene mutation test (JECFA (2001)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	Based on a conclusion of "3-Chloro-1,2-propanediol causes tumors in experimental animals, hence it is considered carcinogen. (non-genotoxic mechanism) agreed in 2007, probable IARC 2B." in expert discussion between ICSC and IARC, the substance was classified into Category 2. In a rat 104-week drinking water test, the mortality rate was unaffected, but dose-related alterations in the incidence of hyperplasia and/or tumours were observed, with increases in the kidney, testis, mammary gland and preputial gland, and decreases in the pancreas. However, the authors concluded that the renal tumours were considered to be secondary to increase in the incidence of chronic progressive nephropathy and the testicular and mammary tumours were suggested to be secondary to the disturbed endocrine balance (JECFA (2001)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	Antifertility in male rats was induced by oral administration for 10 - 12 days and histopathological changes in the testes and epididymides and reduced sperm motility were observed by oral administration at a high dose level (25 mg/kg/day) for 14 days (JECFA (2001)). In a 2- or 4-week oral administration test with male rats, after recovery period, the high dose (8 mg/kg/day) group showed no effects on sperm motility but no pregnancies resulted from the mating with untreated females (JECFA (2001)). The same effects on sperm motility were observed in another rat 9-day oral test in which it was reported that sperm from males of the highest dose did not reach the oviducts of females, the percentage of fertilized eggs in the oviducts of mated females was decreased in a dose-dependent manner (JECFA (2001)). The substance was classified into Category 1B since inhibition of male fertility was observed in rats by oral administration.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
8	Specific target organ toxicity - Single exposure	Category 1 (kidney), Category 2 (central nervous system), Category 3 (respiratory tract irritation)	Danger Warning	H370 H371 H335	P308+P311 P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312	There are reports that renal insufficiency at 130 mg/kg and death from acute glomerulonephritis at 260 mg/kg occurred following oral administration to rats (DFGOT vol. 5 (1993)). It was also reported that microscopic findings such as necrosis and regeneration of the tubular epithelium accompanying precipitated protein in and dilation of the tubules were observed in another test in rats dosed by gavage at levels of 100 - 200 mg/kg (HSDB (2002)). The substance was classified into Category 1 (kidney) since these findings were observed at dose levels within the guidance value range for Category 1. Additionally, clinical observations such as sluggishness, flaccid paralysis of head and legs, and hypnosis were observed in a test in rats dosed by gavage at levels of 100 - 200 mg/kg, and ataxia, grotesque posture, loss of righting reflex, delirium and partial paralysis were observed in a mouse oral test dosed at levels of 100 - 220 mg/kg (HSDB (2002)). Although these findings correspond to Category 1 based on guidance value range, the substance was classified into Category 2 (central nervous system) because of information in List 2 and non-meeting Decision criteria 1b 3). On the other hand, based on reports of minimal irritation to the respiratory tract as clinical signs of toxicity in both rat and mouse inhalation tests (HSDB (2002)), the substance was classified into Category 3 (respiratory tract irritation).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
9	Specific target organ toxicity - Repeated exposure	Category 1 (kidney), Category 2 (blood)	Danger Warning	H372 H373	P260 P264 P270 P314 P501	In rat oral tests, chronic progressive nephrosis was observed after dosing of 60 mg/kg/day for 4 weeks (90-day equivalence: 18.5 mg/kg/day), and after dosing of 1.1 - 35 mg/kg/day for 104 weeks (JECFA (2001)). Since this lesion was observed at dose levels within the guidance value range for Category 1, the substance was classified into Category 1 (kidney). There is a report that hematological abnormalities including anemia, leukopenia, and severe thrombocytopenia were induced by oral administration to 6 monkeys at 30 mg/kg bw/day for 6 weeks and 2/3 monkeys died from myelosuppression (JECFA (2001)). Additionally, in a rat 4-week oral test, significant decreases in hemoglobin concentration, hematocrit and erythrocyte count were reported at dose level of 60 mg/kg/day (90-day equivalence: 18.5 mg/kg/day) (JECFA (2001)). Since these findings was observed at dose levels within the guidance value range for Category 2, the substance was classified into Category 2 (blood system). Additionally, histopathological findings in the testis were also reported, but the effects are considered to be subsumed under reproductive toxicity items and are not classified in specific target organ toxicity.	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)	Not classified	- -	-	-	In preparation. Check the Japanese version.	FY2022	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	In preparation. Check the Japanese version.	FY2022	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	In preparation. Check the Japanese version.	FY2022	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.1))

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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