Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study planned
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS

NON-CONFIDENTIAL NAME OF SUBSTANCE:
Sophorolipids: fermentation products of glucose and fatty acids, C18-unsatd., esters with glycerol with yeast Candida Bombicola, partially hydrolysed

CONSIDERATIONS/JUSTIFICATION FOR THE TESTING PROPOSAL:
In a dose range finding (DRF, non GLP) study for a Reproduction/Developmental Toxicity Screening Study (study name: preliminary prenatal developmental toxicity study in rats) malrotated hindlimbs were observed in one foetus each in one low (100 mg/kg/day) and mid-dose (300 mg/kg/day) female and in three foetuses in two high dose (500 mg/kg/day) females. Rotation of limbs was also present in the Historical Control Data obtained by the Supplier although with a lower incidence, due to the high number of foetuses examined. Further examination is suggested by the test institute in order to evaluate the concern of this finding.
In the subsequently performed OECD 421 (GLP complaint study) these questionable findings could not be clarified, due to the different testing set up. In this study no treatment related findings were noted.
There is no further animal data or historical human data regarding the endpoint reproductive toxicity available. Furthermore, no data on analogue substances are available. There are currently no scientifically validated (Q)SAR or in vitro methods available for this endpoint. Substance-tailored exposure driven testing has not been performed.
None of the given specific adaption possibilities in column 2 of point 8.7 in annex VIII and IX are applicable.
Therefore, to better understand the significance and/or relevance of the findings of the DRF study we deem it necessary to perform a developmental toxicity study (OECD 414, oral, in rats).

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rat

Results and discussion

Applicant's summary and conclusion