Tar, wood

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Remarks:

pre-natal toxicity (OECD 414)

Type of information:

experimental study planned

Justification for type of information:

TESTING PROPOSAL ON VERTEBRATE ANIMALS - OECD 414


NON-CONFIDENTIAL NAME OF SUBSTANCE:
tar, wood

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: Available GLP studies are available in the registration dossier, including a 90-day repeat dose toxicity study. However, none of the available GLP studies fulfil the requirements of the Prenatal Developmental Toxicity Study. No GLP studies on developmental toxicity on the substance itself were identified in literature search.
- Available non-GLP studies: No non-GLP studies on developmental toxicity on the substance itself were identified in literature search.
- Historical human/control data: There are no appropriate historical human data available addressing the developmental toxicity endpoint.
- (Q)SAR: There are no reliable QSAR models addressing the endpoint of developmental toxicity to the extent that is assessed in a Prenatal Developmental Toxicity Study.
- In vitro methods: No validated or regulatory accepted alternative methods are available for replacing animal testing with respect to developmental toxicity.
- Weight of evidence: Considering the lack of valid, regulatory accepted in vitro methods, QSAR models and test data a weight of evidence approach is not possible.
- Grouping and read-across: Tar, wood is a complex UVCB. Read-across using developmental toxicity data on certain constituents of the UVCB was investigated but it was considered that there were no predominant constituents in the UVCB composition to justify a read-across to a single or group of the constituents, also taking into consideration the potential differences individual constituents in physico-chemical properties and possible mechanisms of action.
- Substance-tailored exposure driven testing: An exposure based waiving is not appropriate based on the uses of substance (including consumer uses) and exposure scenarios generated.


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 column 2 adaptations for pre-natal developmental toxicity (Annex IX, 8.7) are not appropriate based on the following:
-the substance is known to be genotoxic carcinogen and appropriate risk management measure are implemented: The substance is not a known genotoxic carcinogen.
-the study does not need to be conducted because the substance is known to be a germ cell mutagen and appropriate risk management measures are implemented: The substance is not a known germ cell mutagen.
-study does not need to be conducted because substance is of low toxicological activity (no evidence of toxicity in any test), it can be proven from toxicokinetic data that no systemic absorption occurs via relevant routes of exposure (e.g. plasma/blood concentrations below detection limit using a sensitive method and absence of the substance and of metabolites of the substance in urine, bile or exhaled air) and there is no or no significant human exposure: The conditions of this waiver are not met based on available data and uses (for the human exposure criteria).
-no testing necessary because the substance is known to cause developmental toxicity: Substance not known to cause developmental toxicity, but OECD 414 proposed.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
An OECD 414 is proposed to address the REACH endpoint requirements for developmental toxicity (which is currently not covered by available data in the registration). In addition an OECD 414 study will also be able to include end points to evaluate any endocrine disruption effects, such as thyroid hormone analysis, which the existing 90-day study does not cover. A proposal for a OECD 414 study will address effects on the developing fetus and it is considered that as a definitive study this will provide sufficient information without the need for screening study (OECD 421).

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 414 (Prenatal Developmental Toxicity Study)

Version / remarks:

2018

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Tar, wood

EC Number:

294-436-0

EC Name:

Tar, wood

Cas Number:

91722-33-7

Molecular formula:

not applicable

IUPAC Name:

Tar, wood

Test animals

Species:

rat