Registration Dossier
Registration Dossier
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EC number: 282-486-6 | CAS number: 84238-17-5
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Additional information
No reproductive toxicity.
Effects on developmental toxicity
Description of key information
No developmental toxicity.
Justification for classification or non-classification
There is no published information on the reproductive toxicity/developmental toxicity of ‘fatty acids, palm-oil, hydrogenated’. However, data is available for some of its constituents.
A number of studies have been conducted on individual fatty acids, as summarized in HERA (2002). At 15% in diet (i.e. ca. 7,500 mg/kg bw/day) for 10 - 16 weeks, oleic acid (C18) did not affect fertility in male rats but appeared to interfere with parturition and mammary gland development in females. The information is however insufficient to be able to verify and conclude on these results. No specific information could be found for fatty acids.
Several fatty acids and their salts (stearic acid; oleic acid and sodium palmitate) are Generally Recognized as Safe (GRAS) by the U.S. Food and Drug Administration (US FDA). Also, fatty acids as a group are permitted as direct food additives (HERA, 2002). Overall, fatty acids are not expected to show developmental toxicity. Dietary exposure to 8.75% in diet (i.e., ca.4,375 mg/kg bw/day) glycerides with chain lengths of C8 - 18, including C18-unsatd. was assessed in a two generation reproductive toxicity study in gerbils (Temmermans et al., 1988). No significant effect on frequency of litters, mean litter size, total no. of newborns and suckling death were observed in the second generation. These results are in line with additional evidence of no developmental effects obtained from another two-generation study conducted in rats exposed to glycerides of chain length ranging from C16-18, including C18-unsatd (Nolen, 1972).Across all studies, tested doses ranged from 8.75 to 15% in diet. No significant toxicity was seen at any of the doses rates. The highest oral NOAEL was 15%in diet which isequivalent to 17,000 to 7,000 mg/kg bw/day, from a 13-weekcombined repeated dose and reproduction/developmental screening (feeding) study.The highest oral NOAEL could be considered to be 15%in diet, which is equivalent to an estimated7,500 mg/kg bw/day for the developmental screening.
Taken together, the above evidence suggests that ‘fatty acids, palm-oil, hydrogenated’ is not a reproductive or a developmental toxicant and therefore do not qualify for classification according to Directive 67/548/EC or Regulation (EC) No. 1272/2008.
Additional information
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