Hydrocarbons, C9-C11, isoalkanes, cyclics, <2% aromatics

Toxicity to reproduction

Administrative data

Endpoint:

extended one-generation reproductive toxicity - with developmental neurotoxicity (Cohorts 1A, 1B without extension, 2A and 2B)

Type of information:

experimental study planned

Study period:

Will be completed in the timescale as indicated in the ECHA decision letter.

Justification for type of information:

This testing proposal has been presented in the lead registrant dossier for this substance submitted to ECHA in 2019. This is a source dossier where the overall approach should be seen in the context of a category of 108 different substances, where the substances are hydrocarbon solvents covering a carbon number range of C5-C20, based on alkane constituents and a range from approximately C8-C18 for aromatic constituents. The basis for this test proposal is set out in detail in the document ‘Hydrocarbon Solvents Test Proposals, Test Plans and Read-Across Strategy for Human Health Endpoints’, which is attached to this endpoint study record and in Section 13.2 of the IUCLID dossier.

TESTING PROPOSAL ON VERTEBRATE ANIMALS

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out : Hydrocarbons, C9-C11, isoalkanes, cyclics, <2% aromatics (EC# 920-134-1)
- Name of the substance for which the testing proposal will be used [if different from tested substance] : Not different

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 : There are no OECD Guideline 443 studies available on this substance to evaluate the reproductive toxicity endpoint.
- Available non-GLP studies : There are no ‘non-GLP’ studies available for this substance to evaluate the reproductive toxicity endpoint.
- Historical human data: No human data exist for this substance to evaluate reproductive toxicity hazard.
- (Q)SAR : There are no recognised (Q)SAR methods available for reliable prediction of reproductive toxicity.
- In vitro methods : There are no in vitro methods currently accepted by Regulatory Authorities for the reliable prediction of reproductive toxicity.
- Weight of evidence : Currently there are insufficient data available to develop a robust weight of evidence approach for reproductive toxicity.
- Grouping and read-across : This test proposal maybe used to help develop a category approach for a wider range of hydrocarbons.
- Substance-tailored exposure driven testing [if applicable] : Insufficient data available
- Approaches in addition to above [if applicable]: None applicable
- Other reasons [if applicable] : None identified

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 are no specific adaptions 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: See 'any other information on materials and methods incl. tables' for further information.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 443 (Extended One-Generation Reproductive Toxicity Study)

GLP compliance:

yes (incl. QA statement)

Justification for study design:

SPECIFICATION OF STUDY DESIGN FOR EXTENDED ONE-GENERATION REPRODUCTION TOXICITY STUDY WITH JUSTIFICATIONS:

See 'any other information on materials and methods incl. tables' for further information.

Test material

Test material information

Constituent 1

Reference substance name:

Hydrocarbons, C9-C11, isoalkanes, cyclics, <2% aromatics

EC Number:

920-134-1

Cas Number:

1174522-20-3

Molecular formula:

none available - not a single isomer - see remarks

IUPAC Name:

Hydrocarbons, C9-C11, isoalkanes, cyclics, <2% aromatics

Test material form:

liquid

Details on test material:

Name of substance: Hydrocarbons, C9-C11, isoalkanes, cyclics, <2% aromatics
EC#: 920-134-1

Test animals

Species:

rat

Sex:

male/female

Administration / exposure

Route of administration:

oral: feed