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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Repeated dose toxicity: oral

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Administrative data

short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
Studies to be scheduled once discussions with ECHA on testing strategy completed
Justification for type of information:
These studies are planned to be conducted as part of the overall Concawe testing strategy for petroleum substances and the OtherGO category; this oral study will also act as a range-finders for an OECD 443 study (subject to test proposal acceptance). More detail on the overall testing strategy is available in the document attached in Section 13 of this dossier ("Concawe HH testing strategy Nov 2018") and the specific strategy for the OtherGO category in the document "OtherGO strategy Nov 2018" attached to the testing proposals in this section of IUCLID.

The aim of this study is:
- act as a range finding study for a planned OECD 443 study
- provide information on repeat-dose toxicity by the oral route
- provide support for the existing historical testing database (primarily via the dermal route of exposure)
- provide support for category read-across
- provide information on genetic toxicity by combining the studies with an OECD 474 study (combining studies allows reduction of animal usage)

Substances will be chosen for testing based on high levels of PAC content and for comparison with existing data.

Data source

Materials and methods

Test guideline
according to guideline
OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
Principles of method if other than guideline:
This study design has been combined to address the endpoints in 2 separate guidelines
• OECD 474 – in vivo micronucleus test
• OECD 422 – combined repeated dose toxicity study with reproductive toxicity screening test
Both of these studies are required to address data gaps for the OtherGO category; combining these studies greatly reduces the number of animals required for testing without compromising the validity of the generated data.

Test material

Constituent 1
Reference substance name:
Gas oils (petroleum), hydrodesulfurized
EC Number:
EC Name:
Gas oils (petroleum), hydrodesulfurized
Cas Number:
Molecular formula:
Not applicable
Gas oils (petroleum), hydrodesulfurized
Specific details on test material used for the study:
Test material is an example of one of the substances expected to be used in the planned studies.

Test animals


Administration / exposure

Route of administration:
oral: feed

Results and discussion

Effect levels

Dose descriptor:
other: results not yet available
Remarks on result:
other: study planned; results not yet available

Applicant's summary and conclusion