GHS Classification Results by the Japanese Government
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 309-00-2 |
| Chemical Name | 1,2,3,4,10,10-hexachloro-1,4,4a,5,8,8a-hexahydro-exo-1,4-endo-5,8-dimethanonaphthalene; aldrin |
| Substance ID | R02-B-044-MHLW, MOE |
| Classification year (FY) | FY2020 |
| 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 |
REFERENCE INFORMATION
| Item | Information |
|---|---|
| Guidance used for the classification (External link) | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0)) |
| 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 classified (Not applicable) |
- |
- | - | There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified." |
| 2 | Flammable gases | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified." |
| 3 | Aerosols | Not classified (Not applicable) |
- |
- | - | Not aerosol products. It was classified as "Not classified." |
| 4 | Oxidizing gases | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified." |
| 5 | Gases under pressure | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified." |
| 6 | Flammable liquids | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified." |
| 7 | Flammable solids | Not classified |
- |
- | - | It was classified as "Not classified" from information that it is not combustible (GESTIS (Access on May 2020)). |
| 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. It was classified as "Not classified." |
| 9 | Pyrophoric liquids | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified." |
| 10 | Pyrophoric solids | Not classified |
- |
- | - | It was classified as "Not classified" from information that it is not combustible (GESTIS (Access on May 2020)). |
| 11 | Self-heating substances and mixtures | Not classified |
- |
- | - | It was classified as "Not classified" from information that it is not combustible (GESTIS (Access on May 2020)). |
| 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). It was classified as "Not classified." |
| 13 | Oxidizing liquids | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified." |
| 14 | Oxidizing solids | Not classified (Not applicable) |
- |
- | - | The substance is an organic compound containing chlorine (but not fluorine or oxygen) which is chemically bonded only to carbon or hydrogen. It was classified as "Not classified." |
| 15 | Organic peroxides | Not classified (Not applicable) |
- |
- | - | Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified." |
| 16 | Corrosive to metals | Classification not possible |
- |
- | - | Classification is not possible because test methods applicable to solid substances are not available. Besides, there is information that it attacks many metals in the presence of water (ICSC (1998)). |
| 17 | Desensitized explosives | Not classified (Not applicable) |
- |
- | - | There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified." |
| Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity (Oral) | Category 2 |
 Danger |
H300 | P301+P310 P264 P270 P321 P330 P405 P501 |
[Rationale for the Classification] It was classified in Category 2 from (1) - (8). [Evidence Data] (1) LD50 for rats: 39 mg/kg (Environmental Risk Assessment for Chemical Substances vol. 1 (Ministry of the Environment, 2002), GESTIS (Access on May 2020), HSDB (Access on May 2020)) (2) LD50 for rats: males: 38-54 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)) (3) LD50 for rats: 38-67 mg/kg (EHC 91 (1989)) (4) LD50 for rats: 39-60 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)) (5) LD50 for rats: 39-64 mg/kg (ATSDR (2002)) (6) LD50 for rats: females: 45 mg/kg (HSDB (Access on May 2020)) (7) LD50 for rats: females: 46-67 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)) (8) LD50 for rats: females: 60 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)) |
| 1 | Acute toxicity (Dermal) | Category 2 |
Danger |
H310 | P302+P352 P361+P364 P262 P264 P270 P280 P310 P321 P405 P501 |
[Rationale for the Classification] It was classified in Category 2 from (1) - (3). [Evidence Data] (1) LD50 for rats: 98 mg/kg (Environmental Risk Assessment for Chemical Substances vol. 1 (Ministry of the Environment, 2002), HSDB (Access on May 2020)) (2) LD50 for rats: < 100 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), EHC 91 (1989)) (3) LD50 for rabbits: 150 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), EHC 91 (1989), HSDB (Access on May 2020)) [Reference Data, etc.] (4) LD50 for rabbits: about 5 mg/kg (EHC 91 (1989)) (5) LD50 for rabbits: 15 mg/kg (GESTIS (Access on May 2020)) |
| 1 | Acute toxicity (Inhalation: Gases) | Not classified |
- |
- | - | [Rationale for the Classification] Solid (GHS definition). It was classified as "Not classified." |
| 1 | Acute toxicity (Inhalation: Vapours) | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Category 1 |
Danger |
H330 | P304+P340 P403+P233 P260 P271 P284 P310 P320 P405 P501 |
[Rationale for the Classification] From (1), LD50 was considered to be lower than 0.027 mg/L, and it was classified in Category 1. Besides, because an exposure concentration was higher than the saturated vapor pressure concentration (0.002 mg/L), a reference value in the unit of mg/L was applied as dust. [Evidence Data] (1) In a test by inhalation exposure of rats to vapors and particles, after 1-hour exposure (converted 4-hour equivalent value: 0.027 mg/L) at 0.108 mg/L, 9 out of 10 rats died (ATSDR (2002)). (2) Vapor pressure of this substance: 0.00012 mmHg (25 deg C) (HSDB (Access on May 2020)) (converted value for the saturated vapor pressure concentration: 0.002 mg/L) |
| 2 | Skin corrosion/irritation | Not classified |
- |
- | - | [Rationale for the Classification] It was classified as "Not classified" from (1), (2). The classification result was changed due to new data obtained. [Evidence Data] (1) In a skin irritation test with rabbits, it caused slight erythema in rare cases. And repeated application as a dry powder did not result in changes in the skin, and slight irritation was observed by dissolving it in vegetable oil (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), EHC 91 (1989)). (2) This substance (technical grade) occasionally caused slight erythema and hardly caused any irritation to the rabbits' skin, not even following application for some weeks (EHC 91 (1989), GESTIS (Access on May 2020)). |
| 3 | Serious eye damage/eye irritation | Classification not possible |
- |
- | - | [Rationale for the Classification] The previous classification was based on data for an emulsion, but because it was impossible to neglect the effects of solvents and surfactants contained in it, it was classified as "Classification not possible" due to lack of data. [Reference Data, etc.] (1) An emulsifiable concentrate formulation of this substance (the content of aldrin: 48%) was applied to the rabbit eye without dilution, and severe initial pain and mild irritation were caused (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), EHC 91 (1989), GESTIS (Access on May 2020)). |
| 4 | Respiratory sensitization | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
| 4 | Skin sensitization | Classification not possible |
- |
- | - | [Rationale for the Classification] There were descriptions in (1) - (3), but it was classified as "Classification not possible" due to lack of data. The classification result was changed because the previous classification was based on the test result on a formulation, and data that enabled classification for this substance were not obtained. [Reference Data, etc.] (1) It was reported to be positive in a skin sensitization test with guinea pigs (maximization test) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)). (2) The experience of large groups of persons exposed did not provide any indication of a sensitizing effect to the skin (EHC 91 (1989), GESTIS (Access on May 2020)). (3) In a skin sensitization test with guinea pigs on an emulsion containing 48% of this substance (maximization test), a positive rate was reported to be 15% (EHC 91 (1989)). |
| 5 | Germ cell mutagenicity | Not classified |
- |
- | - | [Rationale for the Classification] It was classified as "Not classified" from (1) - (3). [Evidence Data] (1) As for in vivo, it was reported to be negative in a dominant lethal test with mice and a micronucleus test with mouse bone marrow cells (EHC 91 (1989), ATSDR (2002), IARC Suppl.7 (1987)). It was reported to be weakly positive in chromosomal aberration tests using bone marrow cells of mice and rats, but it was judged that it could not be used for assessment because it is described in IARC 117 (2019) that methodological details were unknown (IARC Suppl.7 (1987)). (2) As for in vitro, it was reported to be positive in a chromosomal aberration test with cultured mammalian cells and negative in a bacterial reverse mutation test (EHC 91 (1989), ATSDR (2002), IARC Suppl.7 (1987), CEBS (Access on May 2020)). (3) It is described in the Risk Assessment Report (Pesticides) (Food Safety Commission of Japan) that it was considered that it did not have genotoxicity that could pose a problem in vivo (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)). |
| 6 | Carcinogenicity | Category 1B |
 Danger |
H350 | P308+P313 P201 P202 P280 P405 P501 |
[Rationale for the Classification] There was no sufficient report on carcinogenicity in humans concerning exposure to this substance. From (1) - (5), it was classified in Category 1B based on the classification in Group 2A by IARC and B2 by EPA. The classification result was changed based on the IARC's latest classification result. [Evidence Data] (1) As for classification results by domestic and international organizations, it was classified in Group 2A by IARC (IARC 117 (2019)), A3 by ACGIH (ACGIH (2007)), B2 (probable human carcinogen) by EPA (IRIS (1987)), and Carc. 2 in EU CLP (EU CLP classification (Access on May 2020)). (2) In three carcinogenicity tests by 2-year diet administration of this substance to male and female mice (different strains), significant increases in the incidences of liver tumors (hepatocellular adenoma or carcinoma) were observed in both males and females (IARC 117 (2019)). (3) In multiple carcinogenicity tests in which this substance was administered by feeding to male and female rats for 1-2 years, no significant increases in treatment-related tumors were observed (IARC 117 (2019)). (4) In a combined chronic toxicity/carcinogenicity test by diet administration of this substance to male and female rats for 74 weeks for males and 80 weeks for females, thyroid follicular cell adenoma and carcinoma were observed in both males and females (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)). (5) There was inadequate evidence in humans for the carcinogenicity of this substance, but there was sufficient evidence in experimental animals (IARC 117 (2019)). However, because this substance is rapidly metabolized to dieldrin (CAS RN 60-57-1) in humans and experimental animals, for the evaluation of this substance, the evidence on the carcinogenicity of dieldrin was taken into account (IARC 117 (2019)). Dieldrin was classified in Category 1B (GHS classification in 2020). |
| 7 | Reproductive toxicity | Category 1B, Additional category for effects on or via lactation |
Danger |
H360 | P308+P313 P201 P202 P280 P405 P501 |
[Rationale for the Classification] In the reproductive toxicity tests in (1) to (3), a decrease in the number of live pups in the lactation period and effects on the liver and kidney in pups were suggested. Based on (4) and (5), a decrease in the number of viable fetuses and malformations might be caused. Therefore, it was classified in Category 1B, Additional category: Effects on or via lactation. Because of the addition of effects on or via lactation, the classification results were changed from the previous classification. [Evidence Data] (1) In a six-generation reproductive toxicity test with mice dosed by feeding, the most marked effect observed was a decrease in the number of live pups in the lactation period (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)). (2) In a one-generation reproductive toxicity test with dogs dosed by gavage, most pups died within three days after birth, and in a histopathological examination of pups that died, degenerative changes in the liver and renal tubules (slight) were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), EHC 91 (1989)). (3) In a one-generation reproductive toxicity test with dogs dosed by gavage, a delay in estrous cycle was observed in females and a decrease in survival rate in suckling pups was observed. The decrease in survival rate in suckling pups was considered to be due to effects in the fetal period or toxicity of dieldrin in milk of dams (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)). (4) In a developmental toxicity study with female hamsters dosed by gavage on day 7, 8 or 9 of gestation, a decrease in the number of viable fetuses, a decrease in fetal weight and an increase in the incidence of malformations such as cleft palate, open eyes, and webbed feet were observed. The effects were more pronounced in animals dosed on day 7 or 8 of gestation than day 9. Since webbed feet and open eyes were accompanied by a decrease in fetal weight, it was suggested that these effects might be caused by growth retardation (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), EHC 91 (1989)). In the EHC 91 (1989), it was indicated that the significance of these abnormalities in the presence of severe maternal toxicity was doubtful but the possibility of specific teratogenicity could not be ruled out completely. (5) In a developmental toxicity study with female mice given a high dose corresponding to half of the LD50 value by gavage on day 9 of gestation, abnormalities such as webbed feet, cleft palate, and open eyes increased in the control group and the administrated group, but these effects were considered to be associated with maternal toxicity. The incidence of malformed fetuses was 33% (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)). [Reference Data, etc.] (6) The first phase of metabolism of this substance is formation of dieldrin (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)). |
| 8 | Specific target organ toxicity - Single exposure | Category 1 (nervous system), Category 3 (respiratory tract irritation) |
 Danger Warning |
H370 H335 |
P308+P311 P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312 |
[Rationale for the Classification] Based on (1) to (7), it was classified in Category 1 (nervous system) and Category 3 (respiratory tract irritation). A new information source was used and the classification results were changed from the previous classification. [Evidence Data] (1) Intoxication with cyclodiene insecticides such as this substance consists of increased irritability and tremors, followed by tonic-colonic convulsions. In rats orally dosed at high concentrations, convulsions appeared within 1 hour after administration and death followed within 6 hours or within 2 to 7 days (EHC 98 (1989)). (2) Acute exposure caused severe neurotoxic effects (GESTIS (Access on May 2020)). (3) Human exposure caused tremors, giddiness, hyperexcitability, seizures, and comas (HSDB (Access on May 2020)). (4) Workers exposed to dusts complained of malaise, headache, dizziness, nausea, and vomiting (HSDB (Access on May 2020)). (5) Symptoms from 20 minutes to 12 hours after ingestion in humans were malaise, headache, nausea, vomiting, dizziness, tremors, clonic, and tonic convulsions (HSDB (Access on May 2020)). (6) It was reported that, in workers (mostly men) engaged in the manufacturing, handling, and spraying of this substance in the United States, after they were exposed to dusty formulations, acute effects such as eye, skin, or respiratory irritation were observed (HSDB (Access on May 2020)). (7) In human exposure, headache, vertigo, nausea, weakness, and muscular twitching appeared 15 minutes to 24 hours after the exposure. In serious cases, after these symptoms, tonic cramps accompanied by disturbances to consciousness (including epileptiform activities in the EEG) occurred, and severe cardiovascular reactions (tachycardia, hypertension, or hypotension), fever or hypothermia, influence on the functions of the liver and kidneys, and leukocytosis were also observed (GESTIS (Access on May 2020)). |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (nervous system, liver, kidney) |
Danger |
H372 | P260 P264 P270 P314 P501 |
[Rationale for the Classification] Based on (1) to (3), effects on the nervous system, liver, and kidney at doses within the range for Category 1 were observed. Therefore, it was classified in Category 1 (nervous system, liver, kidney). [Evidence Data] (1) In a two-year repeated dose toxicity study with rats dosed by feeding, centrilobular hepatocyte hypertrophy was observed at or above 0.5 ppm (0.025 mg/kg/day, within the range for Category 1) and an increase in mortality, an increase in relative liver weight, hemorrhage in the urinary bladder, and an increased incidence of nephritis were observed at or above 50 ppm (2.5 mg/kg/day, within the range for Category 1) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)). (2) In a 31-month repeated dose toxicity study with rats dosed by feeding, tremors, clonic convulsions, centrilobular cloudy swelling and cell necrosis of the liver were observed at or above 20 ppm (1 mg/kg/day, within the range for Category 1); and an increase in relative liver weight was observed in males at or above 30 ppm (1.5 mg/kg/day, within the range for Category 1) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)). (3) In a 15.6-month repeated dose toxicity study with dogs dosed by feeding, vacuolation of distal renal tubules of the kidney was observed in females at 1 ppm (0.043 to 0.091 mg/kg/day, within the range for Category 1), and increases in absolute and relative liver weight, fatty degeneration of the liver, and vacuolation of renal tubular cells of the kidney were observed at 3 ppm (0.12 to 0.25 mg/kg/day, within the range for Category 1) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)). |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
| Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 11 | Hazardous to the aquatic environment Short term (Acute) | Category 1 |
 Warning |
H400 | P273 P391 P501 |
It was classified in Category 1 from 96-hour LC50 = 0.0022 mg/L for fish (Oncorhynchus mykiss) (Environmental Risk Assessment for Chemical Substances Vol. 1 (Ministry of the Environment, 2002), EHC 91, 1989). |
| 11 | Hazardous to the aquatic environment Long term (Chronic) | Category 1 |
Warning |
H410 | P273 P391 P501 |
Reliable chronic toxicity data were not obtained. It was classified in Category 1 because it is not rapidly degradable (BIOWIN), and it was classified in Category 1 in acute toxicity. |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | This substance is not listed in the Annexes to the Montreal Protocol. |
NOTE:
|