Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study planned
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
1-[(2-tert-butylcyclohexyl)oxy]butan-2-ol
- 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
Not available
- Available non-GLP studies
Not available
- Historical human data
Not available
- (Q)SAR
Not aplicable
- In vitro methods
Not aplicable
- Weight of evidence
Not possible because not available data has been found
- Grouping and read-across
No similar substances with data available have been found
- Substance-tailored exposure driven testing [if applicable]
This substance is used in products going to the final consumer
- Approaches in addition to above [if applicable]
- Other reasons [if 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:
- this substance is registered in a tonnage range 100-1000 tpa and therefore Annex IX of REACh applies.
According to column 2 Annex IX of REACH, Reprotox studies need to be conducted unless the substance is known to be a genotoxic, carcinogen, germ cell mutagen or the substance is of low toxicological activity + it can be proven from toxicokinetic data that no systemic absorption occurs via relevant routes of exposure + there is no or no significant human exposure.
Our substance does not fulfill any of these conditions and therefore a test cannot be waived based on column 2 Annex IX

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed [if relevant]
Not yet discussed

Data source

Materials and methods

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

Test material

Constituent 1
Details on test material:
- Name of test material (as cited in study report): P-#620

Test animals

Species:
rat

Results and discussion

Applicant's summary and conclusion