Hydrotreated mixture of middle straight-run gas oil and soybean oil

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration

Remarks:

Type of genotoxicity: chromosome aberration

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Standard method, GLP-compliant, adequate experimental details for assessment

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.11 (Mutagenicity - In Vivo Mammalian Bone-Marrow Chromosome Aberration Test)

GLP compliance:

yes

Type of assay:

other: in vivo mammalian bone marrow cytogenetic test

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

None

Frequency of treatment:

Once

Post exposure period:

6h, 24h or 48h then sacrified

No. of animals per sex per dose:

Male: 500 mg/kg; No. of animals: 5; Sacrifice time: 6 hours
Male: 500 mg/kg; No. of animals: 4; Sacrifice time: 24 hours
Male: 500 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Male: 1700 mg/kg; No. of animals: 5; Sacrifice time: 6 hours
Male: 1700 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 1700 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Male: 5000 mg/kg; No. of animals: 5; Sacrifice time: 6 hours
Male: 5000 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 5000 mg/kg; No. of animals: 4; Sacrifice time: 48 hours
Female: 500 mg/kg; No. of animals: 5; Sacrifice times: 6 hours
Female: 500 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 500 mg/kg; No. of animals: 5; Sacrifice times: 48 hours
Female: 1700 mg/kg; No. of animals: 5; Sacrifice times: 6 hours
Female: 1700 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 1700 mg/kg; No. of animals: 5; Sacrifice times: 48 hours
Female: 5000 mg/kg; No. of animals: 5; Sacrifice times: 6 hours
Female: 5000 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 5000 mg/kg; No. of animals: 4; Sacrifice times: 48 hours

Control animals:

other: yes, concurrent dosed with deionised water

Positive control(s):

Dosed with 1 mg/kg triethylenelamine (TEM) and sacrificed after 24hrs

Examinations

Tissues and cell types examined:

Bone Marrow

Results and discussion

Test results

Sex:

male/female

Genotoxicity:

negative

Toxicity:

no effects

Additional information on results:

Observations:
No significant increases in frequency of aberrant
chromosomes were seen in test groups.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): negative
Based on the results obtained with analogous substance, it is expected that Renewable Diesel will be non-mutagenic

Executive summary:

Based on the results of tests obtained with analogous substance, it is expected that Renewable Diesel will be non-mutagenic