Registration Dossier

Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study planned
Study period:
after ECHA's final decision depending on laboratory capacity
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: Reaction products of pentaerythritol, propoxylated and 1-chloro-2,3-epoxypropane with hydrogen sulfide

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies: there are no GLP studies available for the endpoint developmental toxicity/teratogenicity
- Available non-GLP studies: there are no non-GLP studies available for the endpoint developmental toxicity/teratogenicity
- Historical human data: there are no historical human data that can be considered acceptable for this higher tier toxicity endpoint.
- (Q)SAR: Although (Q)SAR programmes include several endpoints that are related to developmental toxicity/teratogenicity, these (Q)SAR endpoints do not cover all endpoints that need to be investigated for this toxicity endpoint. In some cases (Q)SAR for this endpoint can be useful as a first indication for possible developmental toxicity/teratogenicity; however absence of structural alerts is considered not acceptable to replace further studies for this toxicity endpoint, neither for registration nor for classification purposes. According to ECHA Practical Guide on alternatives to animal testing (July 2016) ECHA’s experience of using adaptations to address standard informational requirements reveals that there are no simple (Q)SAR solutions for complex health endpoints such as developmental toxicity/teratogenicity.
- In vitro methods: there are no reliable in vitro tests available that can be considered for the endpoint developmental toxicity/teratogenicity that sufficiently cover the endpoint for risk assessment and classification purposes
- Weight of evidence: there is no relevant information available that can be used in a WoE to cover the endpoint developmental toxicity/teratogenicity for registration and classification purposes.
- Grouping and read-across: there are currently no structures known (that also have reliable data on developmental toxicity/teratogenicity) that can be used for grouping or read-across, and which is acceptable for registration and classification purposes.

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 specific rules for adaptation from column 1 as given in column 2 are not met, as the available data do not demonstrate that the substance is a known genotoxic carcinogen or germ cell mutagen. The available data are indicative for systemic absorption, and there are no data available indicative for developmental toxicity meeting the criteria for classification as Repr Cat 1 or 2 with adequate data available to support a robust risk assessment. According to Column 1 (standard information required) of Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), a pre-natal developmental toxicity study in one species is required for substances manufactured or imported in quantities of 100 tonnes or more (ANNEX IX). To fulfill these data requirements, an oral pre-natal developmental toxicity study in rat (OECD 414) is proposed.

Data source

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

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