Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

Data waiving: In accordance with column 2 of REACH Annex VIII and IX, the toxicity to reproduction studies do not need to be conducted since relevant human exposure can be excluded in accordance with Annex XI Section 3.

Effects on developmental toxicity

Description of key information

testing proposal included in the dossier

Link to relevant study records
Reference
Endpoint:
developmental toxicity
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 prenatal developmental toxicity study is required to cover the endpoint developmental toxicity.

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: Reaction products of n-octanol and acrylic acid, first distillation 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 studies available to cover this endpoint
- 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 reproductive toxicity studies do not need to be performed if:
- the substance is known to be a genotoxic carcinogen and appropriate risk management measures are implemented; or
- the substance is known to be a germ cell mutagen and appropriate risk management measures are implemented; or
- the substance is of low toxicological activity (no evidence of toxicity seen in any of the tests available) 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.

None of these conditions are met by the substance: The substance is not classified for carcinogenicity or mutagenicity. Furthermore, no subacute, subchronic or chronic repeated dose toxicity studies are available. Therefore, the above listed column 2 adaptions cannot be applied.


FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed: The proposed study design is in accordance with the OECD 414 guideline (Prenatal Development Toxicity Study). The oral route of exposure is selected based on the physico-chemical properties of the substance. The rat is chosen as the initial species as detailed in ECHA's Endpoint specific guidance R.7a.
Qualifier:
according to guideline
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
GLP compliance:
yes
Species:
rat
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available (further information necessary)
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

There are no indications for a classification for developmental toxicity and teratogenicity at this time. Evaluation will be reconsidered based on the outcome of the proposed prenatal developmental toxicity study.

Additional information