Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study planned
Study period:
upon ECHA's decision
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
2,2'-(Cyclohexylimino)diethanol
- Name of the substance for which the testing proposal will be used [if different from tested substance]

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
No available GLP studies on the substances for the endpoint ‘developmental toxicity’.
- Available non-GLP studies
No available non-GLP studies on the substances for the endpoint ‘developmental toxicity’.
- Historical human data
No human data suggesting developmental toxicity are available for this substance.
- (Q)SAR
No validated (Q)SAR’s exist for this endpoint for this substance. There is no know mode of action for the target substance causing developmental effects.
- In vitro methods
In accordance with ECHA’s guidance on the information requirements and chemical safety assessment , chapter R7a. With regards to in vitro studies for developmental toxicity, the regulatory acceptance of these studies and approaches to replace the animal testing for developmental toxicity has not been achieved as they do not provide equivalent information and thus, cannot be used alone for classification and labelling and/or risk assessment.
- Weight of evidence
Insufficient reliable data are available to complete the data requirements as a weight of evidence approach.
- Grouping and read-across
No or limited information exists for an analogous substance regarding this endpoint.
- 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:
- 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 study is proposed and upon ECHA's approval. The study will be conducted under GLP and according to internationally accepted testing guidelines.

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Deviations:
no
Principles of method if other than guideline:
In the absence of valid in vitro methods, a pre-natal developmental toxicity in the rat as preferred rodent species with the oral route od exposure is proposed.
Limit test:
no

Test material

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

Test animals

Species:
rat

Results and discussion

Results (fetuses)

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion