GHS Classification Result

Chemical Name:Semicarbazide hydrochloride
CAS:563-41-7

Result:
ID: 22A4069
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 Classification not possible - - - - It contains chemical groups (hydrazine structure) associated with explosive properties in the molecule. Since no test results are available, classification is not possible.
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 - - - - No data available.
8 Self-reactive substances and mixtures Classification not possible - - - - It contains chemical groups (hydrazine structure) associated with explosive properties in the molecule. Since no test results are available, classification is not possible.
9 Pyrophoric liquids Not applicable - - - - Solid (GHS definition)
10 Pyrophoric solids Classification not possible - - - - No data available.
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 - - - - The substance is an organic compound containing chlorine which is chemically bonded only to carbon or hydrogen.
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.

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 ...
Based on the mouse LD50 value of 225 mg/kg (HSDB (2005)), the substance was classified into Category 3.
1 Acute toxicity (Dermal) Classification not possible - - - - No data available.
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) Classification not possible - - - - No data available.
2 Skin corrosion/irritation Classification not possible - - - - No data available.
3 Serious eye damage/eye irritation Classification not possible - - - - No data available.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Classification not possible - - - - No data available.
5 Germ cell mutagenicity Not classified - - - - The classification was concluded as "Not classified" based on the negative results in the micronucleus tests using the bone marrow cells obtained from mice after oral administration or using peripheral blood obtained from mice intraperitoneal administration (in vivo mutagenicity test in somatic cells) (Risk assessment report - Veterinary Medicinal Products (2007), Toxicology Letters (2005)), and in vivo gene mutation test using livers and lungs of transgenic mice by orally administration for 28 days (in vivo mutagenicity test in somatic cells) (Risk assessment report - Veterinary Medicinal Products (2007)). As relevant information, negative results in the UDS test using liver cells by oral administration to rats (Risk assessment report - Veterinary Medicinal Products (2007)). As for in vitro studies, positive results in the Ames test using specific bacterial strain (TA1535 and TA100) (Risk assessment report-Veterinary Medicinal Products (2007)), negative results in the chromosome aberration test using Chinese hamster ovary (CHO) cells (Risk assessment report - Veterinary Medicinal Products (2007)), and positive results in the mouse lymphoma TK assay (Risk assessment report - Veterinary Medicinal Products (2007), HSDB (2005)) were reported.
6 Carcinogenicity Classification not possible - - - - The classification was concluded as "Classification not possible" based on the criterion of "Group 3" by the IARC carcinogenicity assessment (IARC supplement 7 (1987)). As relevant information, increased incidences of lung tumors were noted in the 7-month feeding study in mice. And in the life-time administration study in mice via drinking water, increased incidences of lung tumors in females and of vascular-derived tumors containing angioma and angiosarcoma in both sexes were reported (IARC 12 (1976)). On the other hand, in rats, no evidence to induce any tumors was noted in the examination after the study period that was 78-week dietary administration and consequent 26-week withdrawal (in the high dose group, administration was up to 32 weeks due to animal deaths), although osteoporosis of long bones was observed (The EFSA Journal (2005)).
7 Reproductive toxicity Category 2 Warning H361: Suspected of damaging 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 ...
In the oral study using pregnant rats, the offspring had facial abnormalities containing micrognathia and cleft palates (IARC 12 (1976)). In the study using pregnant rats administered on days 10 - 16 of gestation, high incidence of resorption in the dam and of cleft palates in the pups were noted (IARC 12 (1976)). In the study using pregnant rats injected intraperitoneally on days 5, 7, 10, 13, or 15 of gestation, abnormalities in the brain, kidney, intestines, or liver were found in fetuses on the 21th day of the gestation period. In the study using pregnant rats injected intraperitoneally during the organogenetic period, high percentage of hydronephrosis appeared in the fetuses. In the other experimental group with pregnant rats injected intraperitoneally throughout gestation, a statistically significant decrease in the number of implantations and live fetuses resulted (HSDB (2005)). The results mentioned above indicate that the substance has teratogenicity for rats, however, there is no description for the general toxicity of parental animals at these doses. Therefore, the substance was classified as Category 2.
8 Specific target organ toxicity - Single exposure Classification not possible - - - - No data available.
9 Specific target organ toxicity - Repeated exposure Category 2 (bone) Warning H373: May cause damage to organs through prolonged or repeated exposure (bone) P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P314: Get medical advice/attention if you feel unwell.
P501: Dispose of contents/container to ...
In the 90-day feeding study in rats, deformity of the thorax and tail accompanied by enlargement and deformity of the knee joint was observed at the dose level of 500 ppm (40.7 - 44.2 mg/kg/day; corresponded to Category 2 of the guidance values) or higher, and disarrangement of chondrocytes and fissure of cartilage matrix in epiphyseal and articular cartilage were histopathologically evident at all dose levels (18.1 - 70.5 mg/kg/day). These changes were accompanied by proliferation of connective tissue and skeletal deformities at higher doses. The degree of the lesions was potentiated depending on the dose (Food Chemical Toxicology 47 (2009)). Based on the information, the substance was classified as Category 2 (bone). In addition, insufficient calcification of cartilage was also observed in all treatment groups (40 - 140 mg/kg/day) in the 28-day oral dose study in juvenile rats (Food and Chemical Toxicology 47 (2009)).
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 - - - - No data available.
11 Hazardous to the aquatic environment (Long-term) Classification not possible - - - - No data available.
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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