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:
The substance is handled in the EU at volumes of 100 - 1000 tons per annum and therefore, data requirements of Annex X of EC regulation 1907/2006 need to be met.
Since no adaptations to the standard testing requirement can be applied, the registrant proposes to perform an teratogenicity study (OECD 414).


NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: 2-Propyn-1-ol, reaction product with oxirane (1-2.5 mol)

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 GLP study fulfilling the requirements of OECD 414 for the target substance is known to the registrant
- Available non-GLP studies: No non-GLP study fulfilling the requirements of OECD 414 for the target substance is known to the registrant
- Historical human data: No human historical data is known to the registrant
- (Q)SAR: No reliable and adequate (Q)SAR model for this endpoint is known to the registrant.
- In vitro methods: No reliable and adequate in-vitro methods for this endpoint are known to the registrant.
- Weight of evidence: In the absence of the above data, a weight of evidence assessment is not possible.
- Grouping and read-across: No structural analogues with experimental data fulfilling the requirements of OECD 414 for the target substance could be identified by the registrant.
- 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:
The substance does not meet the criteria of specific adaptation possibilities of Annex VI to X and coloumn 2 thereof.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed [if relevant]: see justification for study design below

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
GLP compliance:
yes (incl. certificate)
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat

Administration / exposure

Route of administration:
oral: gavage
Analytical verification of doses or concentrations:
yes
Details on mating procedure:
according to guideline
Duration of treatment / exposure:
according to guideline
Frequency of treatment:
according to guideline
Duration of test:
according to guideline

Results and discussion

Results (fetuses)

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion