Registration Dossier
Registration Dossier
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EC number: 262-992-3 | CAS number: 61788-64-5
Endpoint summary
Administrative data
Description of key information
Acute oral exposure data are available for the sodium salt of sulphated castor oil. No toxicity was observed in a 1984 EC guideline study with rats at a single dose of 15,600 mg/kg bw. Read across from similar substances (sulfited fat liquors EC 307-037-4 fish oil and EC 281-975-1 rape oil) indicate the substances have low acute toxicity. 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.
Similarly to skin Sensitisation, dermal acute toxicity is a systemic end-point and it is related to the possibility for the skin to absorb the substance. Due to the size of the biggest part of the molecule and the polarity due to the salification, low adsorption is estimated, lower than either the sulfited derivative (with an estimated higher Kow). The metabolisation for sulfited and sulfated derivative from the same oil follow a common pattern (see toxicokinetic section), therefore the endpoint has been covered in Read Across from the sulfited derivative.
Furthermore, as agreed during the 15th Meeting of Competent Authorities for REACH and CLP (CARACAL),8 – 9 July 2014, considering the evidence presented as well as the comments by MS, the Commission services consider that an adaptation of point 8.5.3 of Annex VIII to REACH is justified in order to not generate new information on acute dermal toxicity for substances that have shown no toxicity in acute oral toxicity test up to the limit dose of 2000 mg/kg bw and no indications for systemic toxicity in other studies with dermal application (skin irritation or sensitisation studies) have been observed for the analogous substances.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via dermal route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Justification for classification or non-classification
The substance is not considered dangerous for acute toxicity according to the criteria set out in the Regulation EC 1272/2008 (CLP)
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