Condensation products of oil shale alkylresorcinols and formaldehyde

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Type of information:

experimental study planned

Study period:

The results should be available as soon as possible after ECHA's approval.

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: There are no GLP studies available for this endpoint.
- Available non-GLP studies: There are no non-GLP studies available for this endpoint.
- Historical human data: There are no historical human data available for this endpoint.
- (Q)SAR: For this endpoint there is limited availability of (Q)SAR models whose scientific validity has been established, particularly with applicability domains relevant this type of substance. For UVCB substances the documentation from such a prediction may not prove adequate or reliable and the results may not be sufficient for classification, labelling and risk assessment purposes.
- In vitro methods: No validated in vitro methods are available for this endpoint.
- Weight of evidence: There is insufficient data to use a weight of evidence approach to fulfil this endpoint under Annex IX.
- Grouping and read-across: UVCBs pose challenges for hazard evaluation and for judging adequacy of read-across between similar complex substances for data gap filling. Data is not available for the higher tier studies and therefore this data gap remains without an adequate testing proposal.
- Substance-tailored exposure driven testing: Exposure-based waiving of some tests may be permitted in cases where it can be shown that exposure is insignificant or absent for the substance concerned. The substance is not used or transported under strictly controlled conditions throughout the life-cycle and the potential for human contact exists. Therefore exposure-based waiving is not applicable.
- Testing is not technically possible: There are no physical-chemical properties that would suggest that the performance of this test is not technically possible.

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:
- Column 2 outlines the rules for adaptation of the tests specified in Column 1. In the case of the proposed pre-natal developmental toxicity study required under Annex IX, no adaptation is available for this endpoint.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed: In accordance with the principles of reduction, refinement and replacement, the proposed pre-natal developmental toxicity study, will be performed in one species, the rat, via the most appropriate route of administration and having regard to the likely route of human exposure. The test proposed will be performed according to OECD Test Guideline 414 as specified in Column 1 of Annex IX.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 414 (Prenatal Developmental Toxicity Study)

Test material

Test material information

1

Reference substance name:

-

EC Number:

447-830-3

EC Name:

-

Molecular formula:

Not applicable to this UVCB substance.

IUPAC Name:

2-ethylphenol; 3,5-dimethylphenol; formaldehyde; phenol

Test material form:

other: Solid resin

Details on test material:

- Name of test material (as cited in study report): SF-resin (other names: Resin SF-281, SF-281, Resorcinol- formaldehyde resin, Alkyl resorcinol-formaldehyde resin)
- EC number: 447-830-3

Test animals

Species:

rat

Results and discussion

Results (fetuses)

Fetal abnormalities

Abnormalities:

not specified

Overall developmental toxicity

Developmental effects observed:

not specified