Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study planned
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS
[Please provide information for all of the points below. The information should be specific to the endpoint for which testing is proposed. Note that for testing proposals addressing testing on vertebrate animals under the REACH Regulation this document will be published on the ECHA website along with the third party consultation on the testing proposal(s).]

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out : Reaction products of acrylic acid with 2,2'-[oxybis(methylene)]bis[2-ethylpropane-1,3-diol]
- Name of the substance for which the testing proposal will be used [if different from tested substance] : Same as above

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION [please address all points below]:
- Available GLP studies : there are no available GLP studies on the substance or on read-across analogues suitable to fill the endpoint.
- Available non-GLP studies : there are no available non-GLP studies on the substance or on read-across analogues suitable to fill the endpoint
- Historical human data : there is no historical human data on the substance or on read-across analogues suitable to fill the endpoint
- (Q)SAR : (Q)SAR analysis is not sufficient to fill the endpoint. The substance is a complex UVCB and there are no adequate models to address development toxicity.
- In vitro methods : there are no adequate in vitro methods allowing to address a complex endpoint such as development toxicity.
- Weight of evidence : there is not sufficient data on the substance or read-across analogues to be able to establish a weight of evidence argument.
- Grouping and read-across : no suitable analogues with data could be identified to allow grouping or read-across.
- Substance-tailored exposure driven testing [if applicable] : not applicable
- Approaches in addition to above [if applicable]: not applicable.
- Other reasons [if applicable] : not applicable.

CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- All possible adaptation possibilities were considered and none were applicable to this complex UVCB for which no development toxicity testing information is available. Exposure-based waiving could also not be used.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed [if relevant]: An OECD Guideline 414 Prenatal developmental toxicity study is needed to be placed to provide general information concerning the effects of prenatal exposure on the pregnant test animal and on the developing organism; this may include assessment of maternal effects as well as death, structural abnormalities, or altered growth in the foetus.

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Version / remarks:
species: rat
GLP compliance:
yes

Test material

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

Test animals

Species:
rat

Results and discussion

Applicant's summary and conclusion