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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:
experimental study
Adequacy of study:
key study
Study period:
1985
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
GLP compliance:
not specified
Type of assay:
chromosome aberration assay

Test material

Constituent 1
Reference substance name:
64742-80-9
Cas Number:
64742-80-9
IUPAC Name:
64742-80-9
Constituent 2
Reference substance name:
Hydrodesulfurised middle distillate (CAS# 64742-80-9)
IUPAC Name:
Hydrodesulfurised middle distillate (CAS# 64742-80-9)
Test material form:
other: low viscosity liquid hydrocarbon
Details on test material:
- Hydrodesulphurised middle distillate
- Sample API 81-09
- Name of test material (as cited in study report): API 81-09 (CAS# 64742-80-9)
- Physical state: clear, pale straw coloured liquid


Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
intraperitoneal
Duration of treatment / exposure:
single IP dose. Phase dsacrifice at 6, 24 and 48 hrs post dose
Frequency of treatment:
single dose
Post exposure period:
6, 24 or 48 hrs post dose
Doses / concentrations
Remarks:
Doses / Concentrations:
0.3, 1.0 and 3.0 g/kg
Basis:
nominal conc.
No. of animals per sex per dose:
5 animals per dose group for each phased sacrifice time

Examinations

Tissues and cell types examined:
harvested bone marrow cells
Details of tissue and slide preparation:
bone marrow cells harvested 3 hrs after colchicine administration. Slides satined with Geisma

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
no effects
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

There was no evidence of a treament-related effect.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
There was no evidence of a treatment related genetic toxicity effect.
Executive summary:

Three groups of 5 Sprague Dawley rats of each sex were given a single dose test material (3, 1 and 0.3 g/kg) intraperitoneally. One  group of each  treatment and sex was killed 6, 24 and 48 hours after  treatment, having been injected with colchicine two or three hours previously. The bone 

marrow was removed, fixed, stained with Giemsa and  examined for chromosomal aberrations.  Negative and positive control  groups were also included. There was no evidence of a treatment related genetic toxicity effect.