Item | Information |
---|---|
CAS RN | 137-26-8 |
Chemical Name | Thiram |
Substance ID | 23B5510 |
Classification year (FY) | FY2011 |
Ministry who conducted the classification | Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE) |
New/Revised | Revised |
Classification result in other fiscal year | FY2006 |
Download of Excel format | Excel file |
Item | Information |
---|---|
Guidance used for the classification (External link) | Physical Hazards & Health Hazards: GHS Classification Guidance by the Japanese Government (July, 2010) Environmental Hazards: UN GHS Document (4th revised edition) |
UN GHS document (External link) | UN GHS document |
Definitions/Abbreviations (Excel file) | Definitions/Abbreviations |
Model Label by MHLW (External link) | MHLW Website (in Japanese Only) |
Model SDS by MHLW (External link) | MHLW Website (in Japanese Only) |
OECD/eChemPortal (External link) | eChemPortal |
Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
---|---|---|---|---|---|---|
1 | Explosives | Not applicable |
- |
- | - | There are no chemical groups associated with explosive properties present in the molecule. |
2 | Flammable gases (including chemically unstable gases) | Not applicable |
- |
- | - | Solid (GHS definition) |
3 | Aerosols | Not applicable |
- |
- | - | Not aerosol products. |
4 | Oxidizing gases | Not applicable |
- |
- | - | Solid (GHS definition) |
5 | Gases under pressure | Not applicable |
- |
- | - | Solid (GHS definition) |
6 | Flammable liquids | Not applicable |
- |
- | - | Solid (GHS definition) |
7 | Flammable solids | Classification not possible |
- |
- | - | It is combustible (ICSC (J) (2000)), but there are no data in the prescribed test. |
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 applicable |
- |
- | - | Solid (GHS definition) |
10 | Pyrophoric solids | Not classified |
- |
- | - | It was judged to be not pyrophoric from information that it is not self-flammable (IUCLID (2000)). |
11 | Self-heating substances and mixtures | Classification not possible |
- |
- | - | No data 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 |
- |
- | - | Solid (GHS definition) |
14 | Oxidizing solids | Not applicable |
- |
- | - | Organic compounds containing no oxygen, fluorine or chlorine. |
15 | Organic peroxides | Not applicable |
- |
- | - | Organic compounds containing no bivalent -O-O- structure. |
16 | Corrosive to metals | Classification not possible |
- |
- | - | Test methods applicable to solid substances are not available. |
Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
---|---|---|---|---|---|---|
1 | Acute toxicity (Oral) | Category 4 |
Warning |
H302 |
P301+P312
P264 P270 P330 P501 |
Among ten LD50 values for rats (865 mg/kg (IARC 53 (1991)), 1,800 mg/kg, 560 mg/kg, 2,600 mg/kg, 1,080 mg/kg, 1,112 mg/kg, 1,278 mg/kg (the above six: USEPA/HPV (2003), corresponding to List 1), 640 mg/kg (OEL Documentations Vol. 50 (Japan Society For Occupational Health (JSOH), 2008)), 3,700-4,000 mg/kg, 1,800-1,900 mg/kg (the above two: JMPR 853 (1992))), two correspond to "Not classified," and eight correspond to Category 4. Therefore, it was classified in Category 4, to which most corresponded. |
1 | Acute toxicity (Dermal) | Not classified |
- |
- | - | There are two LD50 values for rats of > 2,000 mg/kg and > 5,000 mg/kg (USEPA/HPV (2003)), and two LD50 values for rabbits of >= 2,000 mg/kg bw and > 7,940 mg/kg bw (USEPA/HPV (2003)), all of which correspond to "Not classified." |
1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | Solid (GHS definition) |
1 | Acute toxicity (Inhalation: Vapours) | Classification not possible |
- |
- | - | No data available. |
1 | Acute toxicity (Inhalation: Dusts and mists) | Category 2 |
Danger |
H330 |
P304+P340
P403+P233 P260 P271 P284 P310 P320 P405 P501 |
There are three LC50 values (4 hours) for rats (0.5 mg/L (OEL Documentations Vol. 50 (Japan Society For Occupational Health (JSOH), 2008)), 0.3-1 mg/L (ACGIH (2008)), 4.42 mg/L (SIAP (2010))), which correspond to Category 2, Category 2 - Category 3, Category 4, respectively. It was classified in Category 2, to which most corresponded. Besides, because all the LC50 values were higher than the saturated vapour pressure concentration (2.24E-04 mg/L), these were regarded as tests on dust. |
2 | Skin corrosion/irritation | Not classified |
- |
- | - | There are multiple tests with rabbits, and it was reported to be moderately irritating or slightly irritating after 24-hour exposure and not irritating after 4-hour exposure (USEPA/HPV (2003)). By taking into account EU's classification of R36/38 (EC-JRC (ESIS) (Access on Aug. 2011)), it was classified as "Not classified" in the Classification JIS (Category 3 in UN GHS classification). |
3 | Serious eye damage/eye irritation | Category 2A |
Warning |
H319 |
P305+P351+P338
P337+P313 P264 P280 |
It was reported to be slightly irritating or moderately irritating in multiple tests with rabbits (USEPA/HPV (2003)), and because it is described that the animals recovered within 15 days in one test (EPA/FIFRA u 81-4: GLP) (USEPA/HPV (2003)), it was estimated to take more than seven days to recover. Therefore, it was classified in Category 2A. Besides, the EU classified it in R36/38 (EC-JRC (ESIS) (Access on Aug. 2011)). |
4 | Respiratory sensitization | Classification not possible |
- |
- | - | Data are lacking. Besides, it is reported that the dust of this substance was detected in formulating plants, but due to no reports of respiratory sensitization, the substance does not appear to cause respiratory sensitization in humans (ECETOC TR77 (1999)). |
4 | Skin sensitization | Category 1A |
Warning |
H317 |
P302+P352
P333+P313 P362+P364 P261 P272 P280 P321 P501 |
It was classified in Category 1A because the Japan Society for Occupational Health (JSOH) classified it in occupational skin sensitizers Group 1 (Recommendation of Occupational Exposure Limits (Japan Society For Occupational Health (JSOH), 2010)), and it is listed as a contact allergen in Contact Dermatitis (Frosh) (Contact Dermatitis (Frosh) (4th, 2006), corresponding to List 1). Besides, there are reports that patients with skin diseases from occupational exposure or others were patch tested positive to this substance at high frequencies (DFGMAK-Doc. 15 (2001), ECETOC TR77 (1999), ACGIH (2008)), and this substance was reported to be a causal substance in allergic contact dermatitis in using rubber gloves, soap, fungicide, and seed protectant containing this substance (ECETOC TR77 (1999), ACGIH (2008)). Furthermore, positive results were reported in a guinea pig maximization test and a mouse local lymph node assay (ECETOC TR77 (1999), DFGMAK-Doc. 15 (2001)). |
5 | Germ cell mutagenicity | Category 1B |
Danger |
H340 |
P308+P313
P201 P202 P280 P405 P501 |
It was classified in Category 1B because there are reports of a positive result in a dominant lethal test with mice (in vivo heritable germ cell mutagenicity test) (ACGIH (2008)) as well as a positive result in a chromosomal aberration test with spermatids after oral administration to mice (in vivo germ cell mutagenicity test) (OEL Documentations Vol. 50 (Japan Society For Occupational Health (JSOH), 2008)). Besides, it is reported that it was negative in a chromosomal aberration test with germ cells after oral administration to mice (USEPA/HPV (2003)) and negative or positive in micronucleus tests with bone marrow after intraperitoneal administration to mice (IARC 53 (1991), OEL Documentations Vol. 50 (Japan Society For Occupational Health (JSOH), 2008), USEPA/HPV (2003)). As for in vitro tests, Ames tests, many of which were reported, mostly gave positive results (IARC 53 (1991), ACGIH (2008)), and negative and positive results were reported for chromosomal aberration tests with CHO cells (IARC 53 (1991), USEPA/HPV (2003), ACGIH (2008)). |
6 | Carcinogenicity | Classification not possible |
- |
- | - | It was classified as "Classification not possible" because it was classified in Group 3 for carcinogenicity by IARC (IARC 53 (1991)), and A4 by ACGIH (ACGIH (2008)). Besides, it is reported that no carcinogenicity was observed in any of multiple carcinogenicity tests by 2-year diet administration to rats and mice (EPA/FIFRA TG83-2, GLP; yes) (JMPR No.853 (1992), ACGIH (2008), USEPA/HPV (2003)). |
7 | Reproductive toxicity | Category 2 |
Warning |
H361 |
P308+P313
P201 P202 P280 P405 P501 |
As for developmental toxicity tests by oral administration to pregnant animals during a gestation period, including an organogenesis period, in rats, teratogenicity such as domed cranium, hydrocephalus, and incompletely ossified supraoccipital was observed in addition to decreases in weight gain and food consumption in maternal animals, decreases in implantations and litter size accompanied by increased resorptions (SIAP (2010)). Also, in mice, there is a report on resorptions and reduced fetal development as well as skeletal malformations such as cleft palate, wavy ribs, deformed long bones of the extremities, and micrognathia (IARC 53 (1991)). The reproductive effects above occurred at the dose where parent animals showed general toxicity in rats, and there is no description of general toxicity in parent animals for mice. Therefore, it was classified in Category 2. Besides, no effects on the development of offspring, including teratogenicity, were found in a developmental toxicity test with rabbits (EHC 78 (1988)), while it is reported that no effects on sexual function and fertility were seen in a two-generation reproductive test with rats (SIAP (2010)). |
8 | Specific target organ toxicity - Single exposure | Category 1 (nervous system) |
Danger |
H370 |
P308+P311
P260 P264 P270 P321 P405 P501 |
It is reported that in an acute neurotoxicity test by single oral administration to rats, at or above 150 mg/kg corresponding to the guidance values for Category 1, abnormal functional observation battery (FOB) results were seen two hours post-dosing, and the animals showed reduced motor activities at 3 hours, 7 and 14 days, and at necropsy after 14 days, absolute brain weight was significantly decreased for males at or above 150 mg/kg bw (SIAP (2010), EPA RED (2004)). Furthermore, it is reported that clinical signs of ataxia, tremor, and convulsions were observed at 0.3-1 mg/L (4 hours), corresponding to the guidance values for Category 1 in an inhalation toxicity test with rats (ACGIH (2008)). Based on the above reports, it was classified in Category 1 (nervous system). |
9 | Specific target organ toxicity - Repeated exposure | Category 1 (thyroid, liver), Category 2 (nervous system) |
Danger Warning |
H372
H373 |
P260
P264 P270 P314 P501 |
It is reported that thyroid disorders were more common in the group exposed to this substance exposure than the non-exposed group in a survey on 223 workers who had engaged in the manufacture of thiram generally for more than three years (IARC 53 (1991)). Therefore, it was classified in Category 1 (thyroid). As for experimental animals, there are reports on thyroid hyperplasia after 2-year diet administration of 500 ppm (25 mg/kg/day) to rats (ACGIH (2001), EHC 78 (1988)) and thyroid squamous metaplasia after 80-week diet administration of 50 mg/kg bw/day to rats (ACGIH (2008)). Also, ataxia and incoordination developing into paralysis were observed at 50 mg/kg bw/day (diet administration) in the 80-week test with rats (ACGIH (2008)), and regressive changes in the sciatic nerve accompanied by atrophy of the calf muscle were found after 12-month diet administration of 13.8 mg/kg/day to rats (OEL Documentations Vol. 50 (Japan Society For Occupational Health (JSOH), 2008)). Because these were seen at doses within or above the guidance value range for Category 2, it was classified in Category 2 (nervous system). On the other hand, after 104-week oral administration to dogs, at 4 and 40 mg/kg/day corresponding to the guidance values for Category 1, increased liver enzyme activities were observed, which was histologically confirmed with hepatocellular degeneration (ACGIH (2008)). Therefore, it was classified in Category 1 (liver). Besides, testicular hypoplasia was seen in a 13-week diet administration test with male rats (EHC 78 (1988)), but it was not adopted for classification because the doses exceeded the guidance values for Category 2. |
10 | Aspiration hazard | Classification not possible |
- |
- | - | No data available. |
Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
---|---|---|---|---|---|---|
11 | Hazardous to the aquatic environment (Acute) | Category 1 |
Warning |
H400 |
P273
P391 P501 |
It was classified in Category 1 from 96-hour LC50 = 0.036 mg/L for crustacea (Mysidopsis bahia) (U.S. EPA: RED, 2004). |
11 | Hazardous to the aquatic environment (Long-term) | Category 1 |
Warning |
H410 |
P273
P391 P501 |
Reliable chronic toxicity data were not obtained. Because it is not rapidly degradable (a 2-week degradation rate by BOD: 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1979)), and it was classified in Category 1 in acute toxicity, then it is classified in Category 1. From the above results, it was classified in Category 1. |
12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | This substance is not listed in the Annexes to the Montreal Protocol. |
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