GHS Classification Result

Chemical Name:3-Chloro-1,2-propanediol
CAS:96-24-2

Result:
ID: 21A3610
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 Not classified - - - - Classified into Not classified since flash point is 145 degC (open-cup) (IUCLID (2000)) is >93 degC.
7 Flammable solids Not applicable - - - - Liquid (GHS definition)
8 Self-reactive substances and mixtures Not applicable - - - - There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
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)).
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 ...
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.
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 ...
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.
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 ...
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.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible - - - - No data available.
2 Skin corrosion/irritation Classification not possible - - - - No data available.
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 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.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Classification not possible - - - - No data available.
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)).
6 Carcinogenicity Category 2 Warning H351: Suspected of causing 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 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)).
7 Reproductive toxicity Category 1B Danger H360: May damage 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 ...
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.
8 Specific target organ toxicity - Single exposure Category 1 (kidney), Category 2 (central nervous system), Category 3 (respiratory tract irritation) Danger
Warning
H370: Causes damage to organs (kidney)
H371: May cause damage to organs (central nervous system)
H335: May cause respiratory irritation (respiratory tract irritation)
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 ...
P309+P311: IF exposed or if you feel unwell: Call a POISON CENTER or doctor/physician.
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.
P312: Call a POISON CENTER or doctor/physician if you feel unwell.
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).
9 Specific target organ toxicity - Repeated exposure Category 1 (kidney), Category 2 (blood) Danger
Warning
H372: Cause damage to organs through prolonged or repeated exposure (kidney)
H373: May cause damage to organs through prolonged or repeated exposure (blood)
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 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.
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) Classification not possible - - - - Classification not possible due to lack of data.
11 Hazardous to the aquatic environment (Long-term) Classification not possible - - - - Classification not possible due to lack of data.


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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