GHS Classification Result (Revision of the past classification result)

Chemical Name:1,1-Dimethylhydrazine
CAS:57-14-7

Result:
ID: 22B4526
Classifier: Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
Year Classified: FY2010
Reference Manual: GHS Classification Guidance by the Japanese Government (July, 2010)

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Explosives Not classified - - - - The substance does not fall under Explosives since it is classified into Division 6.1, subsidiary risks 3,8 PG I though it is hydrazines and contains chemical groups (adjacent nitrogen atoms) associated with explosive properties.
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 Category 2 Danger H225: Highly flammable liquid and vapour P303+P361+P353: IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing. Rinse skin with water/shower.
P370+P378: In case of fire: Use ... for extinction.
P403+P235: Store in a well-ventilated place. Keep cool.
P210: Keep away from heat/sparks/open flames/hot surfaces. - No smoking.
P233: Keep container tightly closed.
P240: Ground/bond container and receiving equipment.
P241: Use explosion-proof electrical/ventilating/lighting/.../equipment.
P242: Use only non-sparking tools.
P243: Take precautionary measures against static discharge.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P501: Dispose of contents/container to ...
Since its flash point -15 degC (closed-cup) (ICSC (2008)) is < 23 degC and initial boiling point 63 degC (ICSC (2008)) is > 35 degC, the substance corresponds to Category 2.
7 Flammable solids Not applicable - - - - Liquid (GHS definition)
8 Self-reactive substances and mixtures Not classified - - - - The substance does not fall under Explosives since it is classified into Division 6.1, subsidiary risks 3,8, PG I though it is hydrazines and contains chemical groups (adjacent nitrogen atoms) associated with explosive properties.
9 Pyrophoric liquids Not classified - - - - Since its autoignition temperature is 249 degC (ICSC (2008)), it is considered that the substance does not ignite at room temperature.
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 - - - - Organic compounds containing no oxygen, fluorine or chlorine
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 - - - - Test methods applicable to liquid substance of low-boiling point are not 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 ...
The rat LD50 values of 122 mg/kg bw (Initial Risk Assessment Report (NITE, CERI, NEDO) (2008), PATTY, 5th (2001)), 250 mg/kg bw (PATTY, 5th (2001)) and 360 mg/kg bw (PATTY, 5th (2001)) were reported. The two of them corresponded to Category 3 and the other corresponds to Category 4. The substance was classified as Category 3, as the majority of a number of data corresponded to it.
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 ...
Based on the rabbit LD50 value of 1060 mg/kg bw (Initial Risk Assessment Report (NITE, CERI, NEDO) (2008), ACGIH-TLV (1993) and PATTY, 5th (2001)), the substance was classified as 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 the rat LC50 value of 0.620 mg/L/4hrs (252 ppm/4hrs) (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment) vol. 8 (2010), Initial Risk Assessment Report (NITE, CERI, NEDO) (2008), ASTDR (1997) and PATTY, 5th (2001)), the substance was classified as Category 2. Since 0.620 mg/L is lower than 90% of the saturated vapor pressure concentration (507.8 mg/L), the test substance was treated as "vapor hardly coexisting mists" and the criterion values for gas were adopted.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible - - - - No data available.
2 Skin corrosion/irritation Category 2 Warning H315: Causes skin irritation P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P332+P313: If skin irritation occurs: Get medical advice/attention.
P264: Wash ... thoroughly after handling.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P321: Specific treatment (see ... on this label).
P362: Take off contaminated clothing and wash before reuse.
As for the effects on humans, it was reported that the substance was irritating to eyes, skin and respiratory tract, and caused reddening and pain by contact with eyes and skin (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment) Vol. 8 (2010)). In the skin irritation studies using rabbits or guinea pigs, slight erythema was seen following application of small amounts of the substance (PATTY, 5th (2001)). Based on the information, the substance was classified as Category 2. The substance was classified as "R34" in the EU risk phrases (EC-JRC (ESIS) (Access on Dec. 2010)).
3 Serious eye damage/eye irritation Category 2 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.
As for the human effects, it was reported that the substance was irritating to eyes, skin and respiratory tract, and caused reddening and pain by contact with eyes and skin (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment), vol.8 (2010)). In the eye irritation study using rabbits, mild conjunctivitis, and slight erythema were observed, but symptoms disappeared completely within 5 days (PATTY, 5th (2001)). The substance was classified as Category 2 based on the report that no permanent ocular damage was seen in rodent eyes (PATTY, 5th (2001)).
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Classification not possible - - - - No data available.
5 Germ cell mutagenicity Category 2 Warning H341: Suspected of causing genetic defects 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 ...
The substance was classified as Category 2 based on the positive results in the micronucleus test using mouse liver and in the micronucleus test using mouse spleen (in vivo mutagenicity test in somatic cells) (Initial Risk Assessment Report (NITE, CERI, NEDO (2008), IARC 71 (1999)). As relevant information, positive results were reported in the micronucleus test using mouse sperm (negative results were also obtained with bone marrow micronucleus in the same test, which leads contradiction of the results), and in the DNA strand damage/break test using mouse lung and DNA binding assay using rat liver (in vivo genotoxicity test in somatic cells). As for in vitro studies, positive results were reported in the Ames test (Initial Risk Assessment Report (NITE, CERI, NEDO) (2008)), chromosome aberration tests using Chinese hamster CHL cells and CHO cells (Initial Risk Assessment Report (NITE, CERI, NEDO) Ver.1.0, No.217 (2008), IARC 71 (1999)) and gene mutation tests using mouse lymphoma L5178Y cells and Chinese hamster V79 cells (Initial Risk Assessment Report (NITE, CERI, NEDO) (2008), IARC 71 (1999)).
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 ...
The substance was classified as Category 2 based on the criteria of "Group 2B" in the carcinogenicity assessment of the IARC (IARC 71 (2001)), "RAHC" in the NTP (NTP RoC, 11th (2004)), "A3" in the ACGIH (ACGIH-TLV (2010)), "B2" in the EPA (EPA RED (2009)), "Category 2" in the EU and "Group 2B" in Japan Society For Occupational Health (JSOH) (Recommendations for allowable concentrations (2010)). As relevant information, in the administration tests via drinking water using mice, rats and hamster, tumors of blood vessels, lungs, kidney and liver and lung cancers with remarkable shortening survival period in mice, liver tumors in rats, and vascular and cecum tumors in hamster were reported (Initial Risk Assessment Report (NITE, CERI, NEDO) (2008)). In the 6-month inhalation test using mice and rats, the increases of angiosarcoma and Kupffer cell sarcomas in mice and the increases of lung adenomas, squamous cell carcinomas, pancreatic islet cell carcinomas, fibrous histiocytomas, chromophobe adenomas in rats were reported, however, these tumors might be induced by 0.12% dimethylnitrosamine involved in this substance (Initial Risk Assessment Report (NITE, CERI, NEDO) (2008)).
7 Reproductive toxicity Classification not possible - - - - In the developmental toxicity study in pregnant rats intraperitoneally administered during the organogenetic period, it was reported that reduced body weight gain of dams, reduced fetal weight and increased resorption were observed, but there was no teratogenicity (Initial Risk Assessment Report (NITE, CERI, NEDO) (2008)). As for the sperm morphological effects after intraperitoneal injection in male mice, inconsistent results that one showed increased abnormality, the other no abnormalities (Initial Risk Assessment Report (NITE, CERI, NEDO) (2008)). For reproductive/developmental toxicity, no other data by direct exposure of this material were available. Resorption was observed at the high dose level that maternal body weight reduced, and this data was obtained from the study by intraperitoneal injection. Therefore, the substance was classified as "Classification not possible".
8 Specific target organ toxicity - Single exposure Category 1 (nervous system, respiratory system) Danger H370: Causes damage to organs (nervous system, respiratory system) 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 ...
As for human health effects, it was reported that although exposure concentrations were unknown, by inhalation exposures, symptoms such as respiratory effects, nausea, vomiting, neurological effects and pulmonary edema were observed (PATTY, 5th (2001)), and that the substance revealed coma and effects on the central nervous system by dermal exposure with a large amount of the substance (ATSDR (1997)). Based on the information, the substance was classified as Category 1 (nervous system, respiratory organs). In addition, it was reported that the main symptoms following acute exposure in animal studies was the effects on nervous system such as vomiting and convulsions, and that pulmonary edema and hemorrhage that were considered as secondary effects attributed to hyperglycemia or convulsions were observed in macroscopic pathological examination (Initial Risk Assessment Report (NITE, CERI, NEDO), Ver.1.0, No. 217 (2008))).
9 Specific target organ toxicity - Repeated exposure Category 1 (liver, blood system, nervous system, respiratory system) Danger H372: Cause damage to organs through prolonged or repeated exposure (liver, blood system, nervous system, respiratory system) 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 the investigation cases of workers exposed to the substance, hepatic effects such as increased serum ALT activity and fatty degeneration of the liver, etc. were reported (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment), vol.8 (2010)). The effects on the liver were also reported in workers exposed to the substance during the works to fill the liquid fuel for rockets, which included elevations in serum ALT in 46 workers, and in 26 of them who received liver biopsy examinations, fatty degeneration in the liver was confirmed in 6 workers (Initial Risk Assessment Report (NITE, CERI, NEDO) (2008))). As described above, based on the results of multiple human case reports, the substance was classified as Category 1 (liver). While in the repeated inhalation studies in rats, mice and dogs, clinical signs such as tremor, lethargy and dyspnea etc. were observed in mice and rats exposed at 75 ppm (as vapors) for 6 - 7 weeks (converted concentration as that of 90-day study: approx. 0.09 mg/L), and symptoms of alveolar hemorrhage and pulmonary emphysema were observed in dogs exposed (as vapors) at 25 ppm for 13 weeks (converted concentration as that of 90-day study: 0.06 mg/L), respectively (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment), vol.8 (2010)). Since the dose levels corresponded to Category 1 of the guidance values, the substance was classified as Category 1 (nervous system, respiratory system). Furthermore, slight anemia and hemosiderin deposition in the spleen were observed in dogs exposed by inhalation at 5 ppm for 26 weeks (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment), vol.8 (2010)). And it was reported that the substance might cause hematologic effects and anemia might occur in humans by exposure for a long-term or repeatedly (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment), vol.8 (2010)). Thus, the substance was classified as Category 1 (blood). Overall, the result of the classification was guided to Category 1 (liver, nervous system, respiratory system, blood).
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) Category 2 - - H401: Toxic to aquatic life P273: Avoid release to the environment.
P501: Dispose of contents/container to ...
Classified into Category 2 from its 48h-EC50 = 1.3 mg/L for crustacea (Daphnia magna) (Test for the Ecological Effect of Chemical Substances (Ministry of the Environment), 2009).
11 Hazardous to the aquatic environment (Long-term) Category 2 - H411: Toxic to aquatic life with long lasting effects P273: Avoid release to the environment.
P391: Collect spillage.
P501: Dispose of contents/container to ...
Classified into Category 2 since its acute toxicity is Category 2 and it is not rapidly degradable (BOD degradation rate: 0% (Biodegradation and Bioconcentration of Existing Chemical Substances under the Chemical Substances Control Law, 2000)).
12 Hazardous to the ozone layer Classification not possible - - - - This substance is not listed in Annexes to the Montreal Protocol.


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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