Registration Dossier
Registration Dossier
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EC number: 208-792-1 | CAS number: 541-73-1
Genetic toxicity: in vivo
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
- Principles of method if other than guideline:
- m-dichlorobenzene was administered orally in a single dose of 1000 mg/kg bw to Chinese hamsters. Animals from each group were killed 12, 24 and 48 hours after treatment. The bone marrow obtained from femura was prepared and 50 metaphases per animals were evaluated.
- GLP compliance:
- yes
- Type of assay:
- chromosome aberration assay
Test material
- Reference substance name:
- 1,3-dichlorobenzene
- EC Number:
- 208-792-1
- EC Name:
- 1,3-dichlorobenzene
- Cas Number:
- 541-73-1
- Molecular formula:
- C6H4Cl2
- IUPAC Name:
- 1,3-dichlorobenzene
- Test material form:
- other: liquid
- Details on test material:
- purity: techn. 96% - dest. > 99%
Constituent 1
Test animals
- Species:
- hamster, Chinese
- Strain:
- other: Han: Chin
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Duration of treatment / exposure:
- 12, 24 or 48 hours
- Frequency of treatment:
- single treatment
- Post exposure period:
- none
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1000 mg/kg bw
Basis:
actual ingested
- No. of animals per sex per dose:
- 5 male and 5 femal animals/killing time (12, 24 or 48 hrs)
- Control animals:
- yes, concurrent vehicle
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
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
- Executive summary:
m-dichlorobenzene was administered once orally by gavage in a single dose of 1000 mg/kg bodyweight to male and female Chinese hamsters. This dose had been shown in a preliminary study tobe the maximum tolerated dose.
A positive control group, induced exactly 24 hours later to run parallel with the negative control and the dose group, received Endoxan in an oral dose of 50 mg/kg bodyweight.
Animals from each group were killed 12, 24 and 48 hours after treatment by carbon dioxide asphyxiation. 5 males and 5 females from each group were killed at each of these times.
The bone marrow obtained from femora of the animals was prepared, placed on microskopic slides and stained, after which 50 metaphases per animal were evaluated. The completeness in the number of chromosomes and the various chromatic and chromosomal aberrations were assessed.
Under the conditions of the present study, m-dichlorobenzene caused no significant increase in the aberration rate in the bone marrow cells of the treated animals as compared with the control group.
Endoxan however produced a marked i ncrease in the aberration rate in the test animals.
The results indicate that, under the conditions of the present study, m-dichlorobenzene is not mutagenic in the in vivo chromosome aberration test in bone marrow cells of the Chinese hamster.
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