Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

No data for the toxicity to reproduction was available (See Waiver: Toxicity to Reproduction).


Short description of key information:
Data waiving, study scientificaly unjustified

Effects on developmental toxicity

Description of key information
RA-S, CAS No. 11138-60-6, Key, Azuka and Daston, 2004, Dev. Tox., dermal, RL2 - NOAEL for prenatal development: 2000 mg/kg/d
Additional information

No study was available testing the teratogenicity and prenatal development of the Fatty acids, C16-18, esters with pentaerythritol (CAS No. 85116-93-4). Data of a structural analogue was used in a read-across approach. Decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate (CAS No.11138-60-6) was tested in a prenatal developmental toxicity study according to OECD Guideline 414. The test substance was percutaneously applied to Sprague-Dawley rats for 6 h/day under occlusive conditions. 25 animals per dose were dosed with 0, 200, 600 or 2000 mg/kg/d in corn oil on days 6-15 after gestation.

The two highest dose levels caused some local irritation at the site of application, but no decreases in maternal weight gain or food consumption. There were no differences from control in any of the developmental parameters measured, including embryo/fetal viability, fetal weight, malformations, or variations. Therefore, a NOAEL of 2000 mg/kg/d was derived for prenatal development (RA-S, CAS 11138-60-6, Key, Azuka and Daston, 2004, Dev. Tox., dermal, RL2).

Considering the industrial, professional or general uses of the test compound, the dermal exposure is a relevant way of exposure. No route specific metabolism is expected.

Justification for classification or non-classification

According to the DSD and CLP criteria for classification and labelling of dangerous substances the CAS No. 85116-93-4 (Fatty acids, C16-18, esters with pentaerythritol) is not classified as toxic to reproduction.