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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Genetic toxicity: in vivo

Currently viewing:

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