Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study planned
Study period:
to be determined by ECHA
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS
An OECD 414 in the rat is proposed as it is a standard data requirement in a tonnage band of 100-1000 t/y. Due to the gavage-related reflux of the test substance preparation in corn oil into the respiratory tract/airways which caused severe local effects and mortality in the OECD 408 study, administration of the test material by gavage is not appropriate due to animal welfare reasons.

NON-CONFIDENTIAL NAME OF SUBSTANCE:
2-Butenoic acid, 4-oxo-4-(tridecylamino)-, (Z)-, branched, EC No 701-116-0

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 GLP studies available addressing this endpoint (developmental toxicity / teratogenicity)
- Available non-GLP studies : There are no non-GLP studies available addressing this endpoint (developmental toxicity / teratogenicity)
- Historical human data : There is no historical human data available addressing this endpoint (developmental toxicity / teratogenicity)
- (Q)SAR : QSAR data addressing this endpoint (developmental toxicity / teratogenicity) is not available
- In vitro methods : in vitro methods addressing this endpoint (developmental toxicity / teratogenicity) are not available
- Weight of evidence : There is no data for weight of evidence assessment of this endpoint (developmental toxicity / teratogenicity) available
- Grouping and read-across : Grouping and read-across is not possible as no suitbale read across substances are known to date

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:
- The substance is neither a genotoxic carcinogen nor known to be a germ cell mutagen. Furthermore the substance is not of low toxicological activity and the substance is not classified as Repro Cat. 1A or Cat. 1B. Thus, the specific rules for adaptation of the reach regulation are not adequate to generate the necessary information.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- An OECD 414 in the rat is proposed.

Data source

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar

Administration / exposure

Route of administration:
other: oral (feed or encapsulation). Gavage-related reflux of the substance in corn oil into the respiratory tract/airways caused severe local effects and mortality in the OECD 408 study.Thus, administartion of the test material by gavage is not appropriate.
Vehicle:
not specified

Results and discussion

Applicant's summary and conclusion