Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
developmental toxicity
Type of information:
experimental study planned
Study period:
Upon receipt of ECHA confirmation.
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS
NON-CONFIDENTIAL NAME OF SUBSTANCE:
Benzenepropanoic acid, 3,5-bis(1,1-dimethylethyl)-4-hydroxy-, C13-15-branched and linear alkyl esters
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
No GLP studies for this endpoint are currently available.
- Available non-GLP studies
No non-GLP studies for this endpoint are currently available.
- Historical human data
To the best of the registrants knowledge, no historical human data associated with this endpoint is available.
- (Q)SAR
There are no available QSAR techniques that can adequately model the endpoint.
- In vitro methods
There are no available in vitro techniques that can adequately model the endpoint.
- Weight of evidence
Available evidence from toxicity studies demonstrates that the substance is of negligible concern for this endpoint. An OECD 415 study investigating morphological, physical and behavioral development of the F1 generation beside to have information on a possible teratogenic activity of the test article. The substance was given by oral route to male rats during the pre-mating and mating periods and to female rats during the pre-mating, mating, gestation and lactation periods and did not induce any apparent toxic effects on male animals. The females of the 50 and of the 1000 mg/kg/day had a lower body weight gain and a lower mean daily food consumption. At 1000 mg/kg/day where maternal toxicity was present, an increase of early resorptions and of still birth was also found. No effects on postnatal survival and development of the F1 live pups were noted at any dose. However, as there is no specific study data to address and confirm this endpoint, additional investigations are required.
- Grouping and read-across
Not applicable; there are no similar substances for grouping and read across purposes.
- Substance-tailored exposure driven testing [if applicable]
The substance is used as a stabilising agent in a variety of applications. As there are consumer and professional user applications, exposure cannot be precluded.
- Approaches in addition to above [if applicable]
Not applicable.
- Other reasons [if applicable]
Not applicable.
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:
There is no specific study data to address and confirm this endpoint, additional investigations are required.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
8.7. The studies do not need to be conducted 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.
If a substance is known to cause developmental toxicity, meeting the criteria for classification as Repr Cat 1 or 2 and the available data are adequate to support a robust risk assessment, then no further testing for developmental toxicity will be necessary. However, testing for effects on fertility must be considered.
It is considered that fertility assessment is adequately addressed via the exising OECD 415 study; however no further information is available to examine developmental effects. A basic assessment should be suitable for risk investigation of this endpoint, hence an OECD 414 is proposed.

Data source

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Version / remarks:
As per current guideline; rat.
Deviations:
not applicable
GLP compliance:
yes (incl. QA statement)

Test material

Test animals

Species:
rat
Strain:
not specified

Results and discussion

Applicant's summary and conclusion