GHS Classification Result

Chemical Name:dimethyldioctadecylammonium chloride; DODMAC
CAS:107-64-2

Result:
ID: 20A2037
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 - - - - 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 classified - - - - Organic compounds containing chlorine, which is bonded to nitrogen (but not carbon or hydrogen) via ionic bond. Not oxidizing due to the ionic bond.
15 Organic peroxides Not applicable - - - - Organic compounds containing no bivalent -O-O- structure in the molecule
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) Not classified - - - - Based on several rat LD50 values documented (> 2000mg/kg, 2260mg/kg (male), 2600mg/kg (female) (SIDS (accessed June 2008), EU-RAR (2002)), the substance was classified into "Not classified" in accordance with JIS classification criteria (Category 5 in the United Nations classification).
1 Acute toxicity (Dermal) Not classified - - - - Based on the LD50 of > 2000mg/kg in the tests that complied with OECD TG 404, and based on the fact that no mortality occurred (SIDS (accessed June 2008), EU-RAR (2002)), the substance was classified into "Not classified".
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) Not classified - - - - Based on its rat LC50 > 180mg/L/1h, which is equivalent to 45mg/L/4h (mist) (EU-RAR (2002)), the substance was classified into "Not classified".
2 Skin corrosion/irritation Category 2 Note: the substance of technical grade is in Category 1 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.
In 4-hour skin irritation tests using rabbits, erythema of mild to moderate severity were observed in all animals treated with pure (97%) testing substance. However, these symptoms disappeared within 14 days and no edema was detected. In addition, average scores of Draize tests at 24, 48 and 72 hours after the application were 2, 1, and 0.3, respectively (EU-RAR, vol.14, 2002). From these results, the substance was classified into Category 2. In addition, after the application of the substance of technical grade (77%), moderate irritation was observed, which increased in severity and developed into severe necrosis after 14 days of observation (EU-RAR (vol. 14, 2002)). Based on this result, the substance was classified into Category 1.
3 Serious eye damage/eye irritation Category 1 Note: the substance of technical grade is in 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.
The substance was classified into Category 1 based on the documented cases of severe damage (EU-RAR (2002)) resulted from the tests in which the substance was applied to rabbits' eyes (OECD TG 405). In addition, since the substance of technical grade (77%) was associated with skin corrosion, it was classified into Category 1.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Not classified - - - - No positive reactions were detected in both skin sensitization tests using guinea pigs (maximization tests and epicutaneous tests) and repeated sensitization patch tests on 136 humans (SIDS (accessed in June 2008), EU-RAR (2002)). Since no signs of skin sensitization were observed, the substance was classified into "Not classified".
5 Germ cell mutagenicity Classification not possible - - - - Classification is not possible due to lack of in vivo data, although negative results were available from in vitro tests (SIDS (2000)).
6 Carcinogenicity Classification not possible - - - - No data available.
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 reproductive and developmental tests using rats that were orally administered (OECD TG 421), the following were observed at high doses: prolonged pre-mating period, lowered gestation rates (shown in 6 of 9 rats), and fewer maternal rats that gave birth (shown in 5 of 6 rats) (Initial Risk Assessment Report (NITE, CERI, NEDO)). In addition, general toxicity, such as decreased body weight gain and labored breathing, were detected in parental animals of both sexes at the same high doses (Initial Risk Assessment Report (NITE, CERI, NEDO)). From these results, the substance was classified into Category 2.
8 Specific target organ toxicity - Single exposure Classification not possible - - - - In acute toxicity tests using rats that underwent oral route and inhalation exposure, symptoms of systematic toxicity were observed (SIDS (accessed June 2008) EU-RAR (2002)). However, doses used were higher than the guidance values. Since the effects of the substance at doses within the range of guidance values were not documented, classification is not possible.
9 Specific target organ toxicity - Repeated exposure Classification not possible - - - - The 28-day repeated oral administration test using rats provides the only repeated exposure data useful for toxicity evaluation. In this test, significant effects on the adrenal gland were reported at 500mg/kg/day: increased weight, hypertrophy, discoloration of its surface, peripheral granulocyte infiltration, and hemorrhage (EU-RAR (2002)). Its NOAEL was 100mg/kg/day. Since the upper limit of Category 2 guidance values for 28-day exposure period is 321mg/kg/day (100*90/28), which falls between the NOAEL (100mg/kg/day) and the toxic dose (500mg/kg/day), its effects at the cutoff value cannot be determined. Therefore, classification is not possible based on these data alone.
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 the 48-hour LC50 = 0.16mg/L for crustaceans (Daphnia magna) (Hazard Assessment Report (CERI, NITE), 2005), 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 (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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