Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Dose descriptor:
NOAEL
5 000 mg/kg bw/day
Additional information
Short description of key information:
No reproductive toxicity

Effects on developmental toxicity

Description of key information
No developmental toxicity
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
7

Justification for classification or non-classification

On the basis of reproductive toxicity data on castor oil and a developmental study on 12-hydroxystearic acid itself, the substanceis not expected to show reproductive or developmental toxicity following oral or dermal exposure. This assessment is further supported by the substantial amount of information on the reproductive toxicity and toxicity to reproductive organs of castor oil through its use as a vehicle in toxicity studies as part of the US National Toxicology Programme (CIR, 2007). Likewise, the long history of safe use of structural analogue fatty acids and their related glycerides as present in food oils, as well as the GRAS status for several of the fatty acids indicate their low potential for reproductive and/or developmental toxicity.

Based on the existing information, the substance does not require classification for reproductive or developmental toxicity according to Directive 67/548/EC or Regulation 1272/2008/EC.