Registration Dossier
Registration Dossier
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EC number: 272-211-8 | CAS number: 68783-88-0 Complex combination obtained by steam distillation of soybean oil followed by condensation of the steam. Contains fatty acids, sterols, aldehydes and ketones.
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 of 'soybean oil, deodorizer distillates'. However, data is available for some of its constituents.
A number of studies have been conducted on individual fatty acids, as summarised 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 appered 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.
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 number of newborns or suckling death were found in the second generation.This is in line with findings from studies conducted with other glycerides having long chain lengths ranging from C16-18, including C18-unsatd. and C18-unsatd. hydroxy (Irwin, 1992; Manorama et al., 1993; Coquet et al., 1977). Across all studies for glycerides, 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 is equivalent to 17,000 to 7,000 mg/kg bw/day, from a 13-weekcombined repeated dose and reproduction / developmental screening (feeding) study.
Tocopherols have been tested for reproductive toxicity in a series of studies summarised in Tomassi and Silano (1986) and Fiume (2002). No adverse effects were observed.
A 2-generation reproduction study in rats dosed with up to 5% sterols in diet (i.e. ca. 4,400 mg/kg bw/day) for 10 weeks prior to mating then throughout gestation, lactation and weaning found no significant effects on F0 or F1 generations (ANZFA, 2001).
No specific information could be found for squalene. However, given its long history of safe use in nutritional and cosmetic applications, reproductive toxicity is not expected.
Taken together, the above evidencesuggests that soybean oil, deodorizer distillates is not toxic for reproduction and therefore does not qualify for classification according to Directive 67/548/EC or Regulation (EC) No. 1272/2008.
Additional information
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