Registration Dossier
Registration Dossier
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EC number: 304-835-4 | CAS number: 94279-90-0
Endpoint summary
Administrative data
Description of key information
LD50 casot oil, sulphated, sodium salt oral > 15600 mg/kg
FLL sample 4, limit test, LD50 oral and derma> 2000 mg/kg
FLL sample 3, LD50 oral and dermal > 2000 mg/kg
Oils fish sulphated sodium salt oral > 2000 mg/kg
Oils rape sulphated sodium salt oral and dermal> 2000 mg/kg
Acute toxicity inhalation: not relevant
The more conservative 2000 mg/kg bw no effect levels from the more extensive read across studies was used as the starting point to derive DNELs for the sulfated fat liquors.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Quality of the data base is not very high, but enough to assess acute toxicity of the substance.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
The test performed in 1984 follows old guidelines but it is still representative of the substance toxicity. The other studies submitted for acute dermal toxicity, showed that this class of substance does not show any potential to be toxic after single exposure. Therefore, the test on the target substance is considered valid and taken as key study. However for CAS calculations values of 2000 mg/kg are used, following a more conservative case.
Justification for classification or non-classification
According to the CLP Regulation (EC n. 1272/2008), table 3.1.1, Acute toxicity hazard categories and acute toxicity estimates (ATE) defining the respective categories are the following:
For oral exposure:
Category 1: ATE <= 5 mg/kg bw
Category 2: 5 < ATE <= 50 mg/kg bw
Category 3: 50 < ATE <= 300 mg/kg bw
Category 4: 300 < ATE <= 2000 mg/kg bw
For pure substance ATE can be estimated to be similar to LD50 that can be used for classification.
The LD50, oral of the test substance was determined to be > 2000 mg/kg bw and therefore, the test substance is not classified for Acute toxicity by oral exposure.
For dermal exposure:
Category 1: ATE <= 50 mg/kg bw
Category 2: 50 < ATE <= 200 mg/kg bw
Category 3: 200 < ATE <= 1000 mg/kg bw
Category 4: 1000 < ATE <= 2000 mg/kg bw
The LD50, dermal of the test substance was determined to be > 2000 mg/kg bw and therefore, the test substance is not classified for Acute toxicity by dermal exposure.
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