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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Similar to OECD-guideline 474, all relevant study details available but article in japanese.

Data source

Reference
Reference Type:
publication
Title:
Mutagenicity of environmental substances
Author:
Hachiya N, Taketani A, Takizawa Y
Year:
1982
Bibliographic source:
Nippon Koshu Eisei Zasshi 29: 236-239

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Principles of method if other than guideline:
Chromosome aberration rates and sister chromatid exchange frequency were examined in the peripheral lymphocytes of 38 male workers who were engaged in organic glass production and exposed to methyl methacrylate vapors.
GLP compliance:
not specified
Type of assay:
micronucleus assay

Test material

Constituent 1
Reference substance name:
Methyl methacrylate
EC Number:
201-297-1
EC Name:
Methyl methacrylate
Cas Number:
80-62-6
IUPAC Name:
methyl methacrylate
Details on test material:
no data

Test animals

Species:
mouse
Strain:
other: ddy
Sex:
male

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
Olive oil
Duration of treatment / exposure:
4 doses
Frequency of treatment:
3 doses: once, 24 h before terminal sacrifice
1 dose: 4 split doses every 24 h, the last one 24 h before terminal sacrifice, total duration 5 d
Post exposure period:
24 h
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
Olive oil, 25 mL/kg
Basis:
actual ingested
Remarks:
Doses / Concentrations:
1130, 2260, 4520 mg/kg bw
Basis:
actual ingested
Remarks:
Doses / Concentrations:
4 x 1130 mg/kgbw
Basis:
actual ingested
No. of animals per sex per dose:
6 (repeated treatment of 4 x 1130 mg/kgbw : 5)
Control animals:
yes
Positive control(s):
3 mg Mitomycin C, single dose by i.p. administration 24 h prior to preparation

Examinations

Tissues and cell types examined:
Sampling time for bone marrow: 3 single doses - 24 h post-administration; for repeated administration: 5 days after first administration.
Statistics:
according to Kastenbaum/Bowman

Results and discussion

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

Any other information on results incl. tables

The substance has been administered by gavage as a solution in olive oil in 3 single doses ranging from 1130 mg/kg to 4520 mg/kg (0.5 LD50) 24 h prior to preparation of the bone marrow. A separate group of 5 animals was administered 4 doses of 1130 mg/kg 96, 72, 48 and 24 h prior to preparation. Olive oil (25 ml/kg) was used as the solvent control and mitomycin C (3 mg/kg, i.p.) as the positive control. 2000 erythrocytes were evaluated per animal (12000/10000 per dose). No increase in micronucleated polychromatic erythrocytes was observed at any dose, while an induction of micronuclei was seen in the positive control. MMA was not mutagenic in vivo under test conditions.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
Methy lemthacrylate was not mutagenic in vivo under test conditions.
Executive summary:

The substance has been administered by gavage as a solution in olive oil in 3 single doses ranging from 1130 mg/kg to 4520 mg/kg (0.5 LD50) 24 h prior to preparation of the bone marrow. A separate group of 5 animals was administered 4 doses of 1130 mg/kg 96, 72, 48 and 24 h prior to preparation. Olive oil (25 ml/kg) was used as the solvent control and mitomycin C (3 mg/kg, i.p.) as the positive control. 2000 erythrocytes were evaluated per animal (12000/10000 per dose). No increase in micronucleated polychromatic erythrocytes was observed at any dose, while an induction of micronuclei was seen in the positive control. The substance has been administered by gavage as a solution in olive oil in 3 single doses ranging from 1130 mg/kg to 4520 mg/kg (0.5 LD50) 24 h prior to preparation of the bone marrow. A separate group of 5 animals was administered 4 doses of 1130 mg/kg 96, 72, 48 and 24 h prior to preparation. Olive oil (25 ml/kg) was used as the solvent control and mitomycin C (3 mg/kg, i.p.) as the positive control. 2000 erythrocytes were evaluated per animal (12000/10000 per dose). No increase in micronucleated polychromatic erythrocytes was observed at any dose, while an induction of micronuclei was seen in the positive control. Methyl methacrylate was not mutagenic in vivo under test conditions.