Hydrocarbons, C7-C9, isoalkanes

Repeated dose toxicity: oral

Administrative data

Endpoint:

sub-chronic toxicity: oral

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:

TESTING PROPOSAL ON VERTEBRATE ANIMALS
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.

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out : Hydrocarbons, C7-C9, isoalkanes (EC# 921-728-3)
- 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::
- Available GLP studies : There are no OECD Guideline 408 studies available on this substance to evaluate the sub-chronic toxicity endpoint. These data only exist for structural analogues.
- Available non-GLP studies : There are no ‘non-GLP’ studies available for this substance to evaluate the sub-chronic toxicity endpoint. These data only exist for for structural analogues.
- Historical human data: No human data exist for this substance to evaluate sub-chronic toxicity hazard.
- (Q)SAR : There are no recognised (Q)SAR methods available for reliable prediction of sub-chronic toxicity.
- In vitro methods : There are no in vitro methods currently accepted by Regulatory Authorities for the reliable prediction of sub-chronic toxicity.
- Weight of evidence : Currently there are insufficient data available to develop a robust weight of evidence approach for the sub-chronic 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

According to the adaption principles of Annex XI of the REACH Regulation, there are no existing sub-chronic toxicity data (mammalian and human) for this substance, or for similar compositions, which could subsequently be used for read-across. Consequently, a weight of evidence approach is not sufficient to address this endpoint.

Both in-vitro and in-silico approaches are not considered to be appropriate, as there are no suitable methods which are considered to be valid and reliable to address the requirements for the Sub-Chronic Toxicity (90-Days) toxicity endpoint.

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 short-term toxicity studies (28-days) on this substance
- There are no chronic toxicity studies on this substance

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed [if relevant]: See 'Materials and Methods' Section for further information.

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 (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Hydrocarbons, C7-C9, isoalkanes

EC Number:

921-728-3

Cas Number:

64741-66-8

Molecular formula:

None available - not a single isomer - see remarks

IUPAC Name:

Hydrocarbons, C7-C9, isoalkanes

Test material form:

liquid

Details on test material:

Name of substance: Hydrocarbons, C7-C9, isoalkanes
EC#: 921-728-3

Test animals

Species:

rat

Sex:

male/female

Administration / exposure

Route of administration:

oral: unspecified