GHS Classification Result

Chemical Name：dodine; dodecylguanidinium acetate
CAS：2439-10-3

Result：
ID: 20A2226
Classifier: Ministry of Health, Labour and Welfare （MHLW）, Ministry of the Environment （MOE）
Year Classified: FY2008
Reference Manual: GHS Classification Guidance by the Japanese Government （Sep, 2008）

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Explosives Not applicable - - - - There are no chemical groups 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 solid Classification not possible - - - - No data available.
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 Classification not possible - - - - No data available.
11 Self-heating substances and mixtures Classification not possible - - - - Test methods applicable to solid (melting point <= 140degC) substances are not available. (136degC, Ullmanns (E) (6th, 2003))
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 (but not fluorine or 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. (melting point: 136degC (Howard (1997))

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity （Oral） Category 4 Warning H302: Harmful if swallowed P301+P312: IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P330: Rinse mouth.
P501: Dispose of contents/container to ... 		The substance was classified into Category 4 based on its rat LD50 values (male: 750-1540, 851, and 1931 mg/kg bw; female: 660, 851, and 1117 mg/kg bw) (JMPR (2000)), and its rating of Xn; R22 in the EU classification.
1 Acute toxicity （Dermal） Not classified - - - - Based on its rabbit LD50 value of > 2000 mg/kg (JMPR (2000)), the substance was classified into "Not classified" using the JIS classification criteria (Category 5 or "Not Classified" in the United Nations classification).
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: 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 its rat LC50 values of 0.47 mg/L/4h in males and 0.44 mg/L/4h in females (JMPR (2000)), the substance was classified into Category 2. (Since the test concentration of 0.44 or 0.47 mg/L was higher than the saturated vapour pressure concentration of the test substance: 2.32E-006 mg/L, the substance was estimated to be in a dust state.)
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. 		A rabbit test concluded that the substance was severely irritating 7 days after application (JMPR (2000)), and another rabbit test found that the substance was slightly irritating (JMPR (2000)). Since the EU rated the substance as Xi; R36/38 in its classification, the substance was classified into Category 2.
3 Serious eye damage/eye irritation Category 1 Danger H318: Causes serious eye damage P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P310: Immediately call a POISON CENTER or doctor/physician. 		A rabbit test concluded that the substance caused severe corneal opacity at 21 days after application (JMPR (2000)), and another rabbit test found that the substance was severely irritating (JMPR (2000)). Since corneal clouding did not recover in 21 days, the substance was classified into Category 1.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Not classified - - - - Based on the description that the substance was not sensitizing in the guinea pig tests (JMPR (2000)), it was classified into "Not classified".
5 Germ cell mutagenicity Not classified - - - - Based on two cases of negative results obtained in micronucleus tests using mice that underwent oral administration (in vivo mutagenicity tests using somatic cells) (JMPR (2000)), the substance was classified into "Not classified". As relevant notes, three in vitro mutagenicity tests (Ames test, gene mutation test using ovarian cells of hamsters, and chromosomal aberration tests using human lymphocytes) also yielded negative results (JMPR (2000)).
6 Carcinogenicity Not classified - - - - In 106-week oral administration tests using rats, hepatocellular adenomas and carcinomas were observed in males in a dose-dependent fashion (JMPR (2000)). In addition, 78-week oral administration tests using mice, increased incidences of hepatocellular adenomas and combined hepatocellular adenomas/carcinomas were observed (JMPR (2000)). However, the substance was classified into the "Not classified" category based on the conclusion that it had no risk of carcinogenicity in humans.
7 Reproductive toxicity Classification not possible - - - - In forced oral administration tests using pregnant rats and rabbits, there was no evidence of the administered substance affecting the reproduction and development of the offspring based on relevant parameters (JMPR (2000)). However, since no data are available on sexual functions and fertility of parental animals, the substance was classified into "Classification not possible".
8 Specific target organ toxicity - Single exposure Classification not possible - - - - No data available.
9 Specific target organ toxicity - Repeated exposure Category 2 (systemic toxicity) Warning H373: May cause damage to organs through prolonged or repeated exposure (systemic toxicity) 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 ... 		Results of oral route exposure tests were gathered from the following nine tests: four mixed diet tests using rats (4 weeks, 28 days, 90 days, and 106 weeks); one stomach tube administration test (4 weeks); three mixed diet tests using mice (8 weeks, 13 weeks, and 78 weeks); and one mixed diet test using dogs (52 weeks) (JMPR (2000)). Among these tests, four mixed diet tests using rats (4 weeks, 28 days, 90 days, and 106 weeks) and one mixed diet test using dogs (52 weeks) did not provide any indications of serious toxic effects at the highest doses within the range of guidance values tested, as well as any data useful for the classification of the substance. In the three mixed diet tests using mice (8 weeks, 13 weeks, and 78 weeks), congestion of the lung, cellular depletion of the spleen and lymphoid atrophy, and/or necrosis of the thymus were observed at the doses higher than the upper limit of the guidance value range; no serious toxic effects were observed at the doses that fall under the guidance value range, however. On the other hand, the stomach tube administration test (4 weeks) resulted in occurrence of mortality cases at all doses tested (75, 100, and 200 mg/kg/day (90-day correction values: 23, 31, and 62 mg/kg/day)), and symptoms such as salivation, deteriorating health status, and respiratory distress occurred in a dose-dependent fashion. At the highest dose of 200 mg/kg/day, an increase in BUN, total bilirubin, and GPT; a decrease in glucose, protein, and albumin were observed; in addition, as histopathological symptoms, lesions were observed in the stomach, spleen, thymus, adrenal glands, and intestines. Furthermore, at the doses of 75 or 100 mg/kg/day, edema, mixed-cell infiltration, and hyperplasia of the squamous mucosa of the stomach were detected by gastrointestinal tests. The development of lesions in the stomach is likely to be caused by the irritating property of the test substance, but taking cases of death and other observed effects into account, it is difficult to specify a target organ on which the substance has an impact. Therefore, the substance was classified into Category 2 for systemic toxicity. In the case of dermal exposure, rats that received doses (maximum dose: 200 mg/kg/day (90-day correction: 62 mg/kg/day)) for 3 or 4 weeks did not show notable systemic toxicity as the effect of the test substance, excluding the development of lesions on the skin where the substance was applied (JMPR (2000)). Based on this dataset, classification is not possible.
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 1 Warning H400: Very toxic to aquatic life P273: Avoid release to the environment.
P391: Collect spillage.
P501: Dispose of contents/container to ... 		Since its 48-hour EC50 = 0.0178 mg/L for crustaceans (Daphnia magna) (Aquire, 2008), the substance was classified into Category 1.
11 Hazardous to the aquatic environment （Long-term） Category 1 Warning H410: Very toxic to aquatic life with long lasting effects P273: Avoid release to the environment.
P391: Collect spillage.
P501: Dispose of contents/container to ... 		Since its classification for acute toxicity is Category 1, and it is not rapidly degradable (estimated value: SRC: BioWin V4.10), the substance was classified into Category 1.


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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