[No public or meaningful name is available]

Repeated dose toxicity: oral

Administrative data

Endpoint:

sub-chronic toxicity: oral

Type of information:

experimental study planned

Study period:

As per timings provided in ECHA final decision

Justification for type of information:

TESTING PROPOSAL ON VERTEBRATE ANIMALS
According to REACH regulation Annex IX the conduct of a 'Sub-chronic toxicity study (90-day) is required to cover the endpoint repeated dose toxicity.

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: Condensation Products of cyclopentanone and pentaldehyde, fractionation pitch

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION
- Available GLP studies: No sub-acute or subchronic studies on repeated dose toxicity are currently available
- Available non-GLP studies: no studies available
- Historical human data: no data available
- (Q)SAR: No adequate QSAR model is available to fulfill this information requirement.
- In vitro methods: Currently no validated and accepted in vitro methods are available to cover this endpoint. It is currently not possible, with in-vitro models, to account for the influence of the complex processes of absorption, distribution in the body, metabolism and excretion that occur in the whole animal, which will affect the toxic properties of the test substance.
- Weight of evidence: No adequate data are available, neither for the target substance, nor for related substances, to cover this endpoint.
- Grouping and read-across: The substance is a UVCB substance, and no adequate alternative substance with data suitable for read-across purposes is available.
- Substance-tailored exposure driven testing [if applicable]: Based on use conditions, exposure cannot be completely excluded.
- Approaches in addition to above [if applicable]: n.a.
- Other reasons [if applicable]: n.a.

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 of Annex IX states, that the sub-chronic toxicity study (90 days) does not need to be conducted if:
- a reliable short-term toxicity study (28 days) is available showing severe toxicity effects according to the criteria for classifying the substance as R48, for which the observed NOAEL-28 days, with the application of an appropriate uncertainty factor, allows the extrapolation towards the NOAEL-90 days for the same route of exposure, or
- a reliable chronic toxicity study is available, provided that an appropriate species and route of administration were used, or
- a substance undergoes immediate disintegration and there are sufficient data on the cleavage products (both for systemic effects and effects at the site of uptake), or
- the substance is unreactive, insoluble and not inhalable and there is no evidence of absorption and no evidence of toxicity in a 28-day ‘limit test’, particularly if such a pattern is coupled with limited human exposure.

None of the specific adaptations described above are applicable (neither sub-acute not chronic toxicity studies are available to support either of the rules for adaptation stated above). The general rules for adaptation of the standard testing regime set out in Annexes VII to X (REACH Annex XI), are also not appropriate to adapt the requirements for this test.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Condensation products of cyclopentanone and pentaldehyde, fractionation pitch

Molecular formula:

not applicable, UVCB

IUPAC Name:

Condensation products of cyclopentanone and pentaldehyde, fractionation pitch

Test animals

Species:

rat

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Results and discussion

Target system / organ toxicity

Critical effects observed:

not specified