Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study planned
Remarks:
testing proposal
Justification for type of information:
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies
No valid study on this endpoint is available for classification and labelling and/or risk assessment purposes. One Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test (OECD422) is available; however no sufficent information on developemental toxicity are available to meet the information requirements in Annex IX of Regulation (EC) 1907/2006 by Regulation (EU) 2015/282

- Available non-GLP studies
No non-GLP study is available on this endpoint

- Historical human data
No historical human data are available

- (Q)SAR
No valid (Q)SAR models on this endpoint are available for classification and labelling and/or risk assessment purposes

- In vitro methods
No valid in–vitro methods on this endpoint are available for classification and labelling and/or risk assessment purposes

- Weight of evidence
No sufficient information to perform WoE assessments are available

- Grouping and read-across
No appropriate structural analogues are available

CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (COLUMN 2) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Based on the existing data, adaptation options as defined in Annexes VI to X were not applicable for this substance and this endpoint.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
The proposed study will be conducted under GLP and according to OECD TG 414. The test species will be rat, and the route of administration will be oral (gavage).

Data source

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2'-(octylimino)bisethanol
EC Number:
239-555-0
EC Name:
2,2'-(octylimino)bisethanol
Cas Number:
15520-05-5
Molecular formula:
C12H27NO2
IUPAC Name:
2-[(2-hydroxyethyl)(octyl)amino]ethan-1-ol

Test animals

Species:
rat

Results and discussion

Applicant's summary and conclusion