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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 / erythrocyte micronucleus
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Deviations:
yes
Remarks:
- limited documentation
GLP compliance:
yes
Type of assay:
mammalian erythrocyte micronucleus test

Test material

Constituent 1
Chemical structure
Reference substance name:
Methanol
EC Number:
200-659-6
EC Name:
Methanol
Cas Number:
67-56-1
Molecular formula:
CH4O
IUPAC Name:
Methyl alcohol

Test animals

Species:
mouse
Strain:
Swiss Webster
Sex:
male
Details on test animals or test system and environmental conditions:
no information given


Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
no information given
Details on exposure:
no information given
Duration of treatment / exposure:
4 days
Frequency of treatment:
no information given
Post exposure period:
24 h
Doses / concentrationsopen allclose all
Dose / conc.:
300 mg/kg bw/day (nominal)
Dose / conc.:
600 mg/kg bw/day (nominal)
Dose / conc.:
1 200 mg/kg bw/day (nominal)
Dose / conc.:
2 500 mg/kg bw/day (nominal)
No. of animals per sex per dose:
10
Control animals:
yes
Positive control(s):
Caffeine (-folate)
Urethane (+folate)

Examinations

Tissues and cell types examined:
erythrocytes from blood samples
Details of tissue and slide preparation:
see any other information on materials and methods
Evaluation criteria:
no information given
Statistics:
no information given

Results and discussion

Test results
Key result
Sex:
male
Genotoxicity:
negative
Toxicity:
not specified
Vehicle controls validity:
not specified
Negative controls validity:
not examined
Positive controls validity:
valid
Additional information on results:
see remarks on results

Any other information on results incl. tables

Folate limitation resulted in an about 15-20 times lower folate blood level than in the high-folate groups.

4/10 folate-deficient animals receiving 2500 mg/kg died between days 2 and 3.

No difference in micronucleus frequency (MN in PCEs) and in RNA-positive blood erythrocytes was seen between treated groups and controls while animals treated with the positive control substances responded as expected:

+folate: MN 0.17 - 0.23 % vs. 0.23 % in saline control

-folate: MN 0.31 - 0.37 % Vs. 0.38 % in saline control.

Caffeine (+folate): MN 0.34 %

Caffeine (-folate): MN 2.42 %

Urethane (+folate): MN 2.52 %.

Applicant's summary and conclusion

Conclusions:
negative
Executive summary:

The results indicate that methanol is nonclastogenic to the developing erythroblast in bone marrow and does not inhibit red blood cell production in either normal or folate-deficient mice.