Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study planned
Study period:
The study will be performed following acceptance of this vertebrate testing proposal by ECHA.

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
Testing of the substance oct-1-ene (EC Number 203-893-7, CAS number 111-66-0) and C20-C22 (even numbered, linear and branched) and C24 (branched) alkenes (EC number 931-269-0) is proposed.Typical compositions and analyses, together with details of the suppliers of the test materials, are detailed in the document “HOPA testing proposal details” attached to Section 13 of the Iuclid data set. The exact composition of the test materials will be defined after analysis of the batch to be used. For further information on the structures proposed for testing and other category members, see the Category Justification Document also the associated category matrix report. These reports are attached to Section 13 of the IUCLID dossier. The matrix report is also contained within the Chemical Safety Report

Results and discussion

Results (fetuses)

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Executive summary:

Two OECD 414 developmental toxicity tests are being proposed for oct-1-ene (CAS number 111-66-0) and C20-C22 (even numbered, linear and branched) and C24 (branched) alkenes (EC 931-269-0). This will extend the overall amount of information available on the developmental toxicity potential of the category as a whole, and permit interpolation over the carbon number range C6 to C20-22-C24; and also minimise unnecessary animal testing as required by REACH Article 25. Additional testing, proposed elsewhere, will provide supporting information on the reproductive toxicity potential of oct-1-ene and C20-C22 (even numbered, linear and branched) and C24 (branched) alkenes and on the repeated dose (sub-chronic) toxicity of oct-1-ene and octadec-1-ene.