Registration Dossier

Toxicological information

Genetic toxicity: in vivo

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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:
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