GHS Classification Result

Chemical Name:1-[(2R,4S,5S)-4-Azido-5-(hydroxymethyl)oxolan-2-yl]-5-methylpyrimidine-2,4-dione, (alias Zidovudine)
CAS:30516-87-1

Result:
ID: 21A3752
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 Classification not possible - - - - Classification is not possible since no data are available though the substance contains chemical groups (R-N=N=N) associated with explosive properties present in the molecules.
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 - - - - Classification is not possible since no data are available though there are chemical groups (R-N=N=N) associated with explosive properties present in the molecules.
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 - - - - Test methods applicable to solid (melting point <= 140 degC) 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 - - - - Solid (GHS definition)
14 Oxidizing solids Not applicable - - - - The substance contains oxygen in the molecule 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) Classification not possible - - - - Classification not possible due to lack of data. As relevant information, a LD50 value is 3084 mg/kg bw for rats (RTECS (2009)).
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 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 ...
Based on positive results in mouse bone marrow and peripheral lymphocyte micronucleus tests by oral, intraperitoneal or intravenous exposure (in vivo somatic cell mutagenicity test) (IARC vol. 76 (2000)), the substance was classified into Category 2. As relevant information, from in vitro mutagenicity tests, there are reports of positive results in an Ames test, chromosomal aberration and sister chromatid exchange tests using Chinese hamster CHO cells, a mouse lymphoma L5178Y cell gene mutation test, a human lymphocyte chromosomal aberration test and a micronucleus test as well as a human hepatocyte (HepG2 cell) gene mutation test (IARC vol. 76 (2000), NTP DB (access on Oct. 2009)).
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 the classification of "Group 2B" in IARC (IARC vol. 76 (2000)), the substance was classified into Category 2. It was reported that administration by gavage induced vaginal squamous-cell carcinomas in carcinogenicity tests in mice and rats.
7 Reproductive toxicity Category 2, Additional category: Effects on or via lactation Warning H361: Suspected of damaging fertility or the unborn child
H362: May cause harm to breast-fed children
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 ...
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P263: Avoid contact during pregnancy/while nursing.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
In an oral administration test in pregnant rabbits (37.5, 75 or 250 mg/kg/day on days 6 - 18 of gestation), dams were reported to have reduced weight gain and decreased hemoglobin concentration, hematocrit and red blood cell count, and the effects on fetuses included decreased weights and increased numbers of resorptions at the highest dose level, but no teratogenic effects were reported (IARC vol. 76 (2000)). Additionally, when rats were treated before mating and throughout gestation and lactation, early embryo mortality was increased and the number of live fetuses per litter and fetal body weight were decreased (IARC vol. 76 (2000)). Based on these information, the substance was classified into Category 2. In addition, since it was reported that in a human test (200 mg, single oral), the substance is distributed into milk and the concentrations in milk were similar to concurrent serum concentrations, the substance was classified as "Effects on or via lactation" (JAPIC prescription drug book (2010)). There is information that the substance crosses the placenta (JAPIC prescription drug book (2010)).
8 Specific target organ toxicity - Single exposure Category 1 (bone marrow) Danger H370: Causes damage to organs (bone marrow) 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 ...
Based on a report that the substance is an antiviral drug and has significant side effects including myelosuppression (serious hematologic disorder) (JAPIC prescription drug book (2010)), the substance was classified into Category 1 (bone marrow).
9 Specific target organ toxicity - Repeated exposure Category 1 (bone marrow) Danger H372: Cause damage to organs through prolonged or repeated exposure (bone marrow) 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 ...
Based on reports that anaemia and bone-marrow depression occurred in treated patients (IARC vol. 76 (2000), NTP TR469 (1999)), the substance was classified into Category 1 (bone marrow). As relevant information, there are animal test reports that bone-marrow depression and anaemia were observed in mice receiving orally (IARC vol. 76 (2000), NTP TR469 (1999)).
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.


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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