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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
Studies to be scheduled: initial studies planned to start in Q1 2018 with results available in Q4 2018
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 OGO category and one substance 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.

The aim of these studies 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

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

Data source

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)

Test material

Constituent 1
Reference substance name:
Distillates (petroleum), full-range straight-run middle
EC Number:
272-341-5
EC Name:
Distillates (petroleum), full-range straight-run middle
Cas Number:
68814-87-9
IUPAC Name:
Distillates (petroleum), full-range straight-run middle
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

Species:
rat

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

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