Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study planned
Study period:
After approval by ECHA
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: citronellyl formate (CAS number: 105-85-1, EC number: 203-338-9)

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies: Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test according to OECD guideline 422
- Available non-GLP studies: There are no non-GLP studies available covering developmental toxicity / teratogenicity information requirements.
- Historical human data: There are no historical human data available on developmental toxicity / teratogenicity for the substance.
- (Q)SAR: At present there is no valid (Q)SAR model available to address developmental toxicity / teratogenicity.
- In vitro method: At present there is no valid in vitro method available to address developmental toxicity / teratogenicity.
- Weight of evidence: There are no data available which are sufficient for weight of evidence approach.
- Grouping and read-across: No substances or a category of substances are known which apply for read across addressing developmental toxicity / teratogenicity.
- Substance-tailored exposure driven testing: not applicable
- Approaches in addition to above: not applicable
- Other reasons: 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:
According to REACH Regulation EC No 1907/2006, Annex VIII, Section, 8.7.1 for substances registered in the tonnage band 10 to 100 tonnes a Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test according to OECD guideline 422 should be performed to assess the developmental toxicity of the test substance. Since this study revealed concerns about the potential for adverse effects on development, a Prenatal Development Toxicity Study according to OECD guideline 414 (REACH Regulation EC No 1907/2006, Annex IX, Section 8.7.2) is proposed to further investigate the developmental toxicity. The available study according to OECD guideline 422 is not sufficient to finally conclude on classification and labeling.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed:
A Prenatal Development Toxicity Study according to OECD guideline 414 is proposed to further assess the developmental toxicity of the test substance. The test substance is proposed to be administered orally by gavage to rats. Doses will be based on data available from the performed Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test according to OECD guideline 422.

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Version / remarks:
2018
GLP compliance:
yes
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat

Administration / exposure

Route of administration:
oral: gavage

Results and discussion

Applicant's summary and conclusion