Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Species:
rat
Quality of whole database:
The absence of reproductive toxicity in a modern, guideline-compliant one-generation toxicity study performed in the rat with the read-across substance behenyl alcohol at a dose level of 1000 mg/kg bw/d is supported by the absence of reproductive toxicity in a 4-generation rat study performed with the read-across substance stearyl citrate.
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

Studies indicate that the intact substance is not absorbed following oral administration, but do indicate some gastrointestinal hydrolysis. The hydrolysis products of the substance (i.e.citric acid and C18/20/22 fatty alcohol) are likely to be absorbed, although the absorption of fatty alcohols may be incomplete. Citric acid is present in the body as a normal metabolic intermediate and therefore does not raise any concerns of relevance to reprodutive toxicity. Fatty alcohols are converted to the corresponding fatty acid in gastrointestinal mucosal cells and will subsequently be incorporated into normal fatty acid metabolism in the liver. The study of reproductive toxicity performed with the (C22) fatty alcohol, behenyl alcohol, clearly demonstrates an absence of reproductive toxicity at the limit dose level of 1000 mg/kg bw/d and are representative of C18 and C20 fatty alcohols. The results of this study clearly demonstrate that the levels of fatty alcohol potentially released from the gastrointestinal hydrolysis of the substance do not raise any concerns of relevance to reproductive toxicity. A four-generation rat study performed with the read-across substance stearyl citrate similarly did not reveal any reproductive toxicity at dose levels up to 9.5% in the diet (equivalent to a dose level of approximately 7600 mg/kg bw/d).

The evidence therefore confirms the very low toxicity of the substance and demonstrates an absence of reproductive toxicity, even at very high dose levels.


Short description of key information:
No evidence of reproductive toxicity was observed in a one-generation rat toxicity study performed with the read-across substance behenyl alcohol at a dose level of 1000 mg/kg bw/d. No evidence of reproductive toxicity was observed in a four-generation rat toxicity study performed with the read-across substance stearyl citrate at a dose level of 7600 mg/kg bw/d.

Justification for selection of Effect on fertility via oral route:
Modern, guideline-compliant study, performed with a read-across substance. The results of this study are supported by the absence of effects in an older, non-standard 4-generation rat study.

Effects on developmental toxicity

Description of key information
A modern study of developmental toxicity in the rabbit with the read-across substance behenyl alcohol does not indicate any effects at the dose level of 2000 mg/kg bw/d .A modern study of developmental toxicity in the rat with the read-across substance behenyl alcohol does not indicate any effects at the dose level of 1000 mg/kg bw/d.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Species:
rabbit
Quality of whole database:
Two guideline and GLP-compliant studies are available, in the rat and rabbit.
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

Studies indicate that the intact substance is not absorbed following oral administration, but do indicate some gastrointestinal hydrolysis. The hydrolysis products of the substance (i.e. citric acid and C18/20/22 fatty alcohol) are likely to be absorbed. Citric acid is present in the body as a normal metabolic intermediate and therefore does not raise any concerns of relevance to developmental toxicity. Fatty alcohols are converted to the corresponding fatty acid in gastrointestinal mucosal cells and will subsequently be incorporated into normal fatty acid metabolism in the liver. The studies of developmental toxicity performed with the (C22) fatty alcohol, behenyl alcohol, clearly demonstrate an absence of maternal and developmental toxicity even at very high dose levels and are representative of C18 and C20 fatty acids. The results of these studies clearly demonstrate an absence of developmental toxicity for the registered substance, even at very high dose levels.


Justification for selection of Effect on developmental toxicity: via oral route:
Two guideline and GLP-compliant studies are available, in the rat and rabbit. No effects were observed in either species. The endpoint from the rat study is selected as this is the preferred first species for this type of study according to the REACH Regulation and associated guidance.

Justification for classification or non-classification

There is no indication of developmental or reproducitve toxicity even at very high dose levels. The substance is therefore not classified for developmental or reproductive toxicity according to the CLP Regulation.