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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro DNA damage and/or repair study
Remarks:
Type of genotoxicity: DNA damage and/or repair
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The robust study summary was received from the ECHA in accordance with Article 25(3) (the "12-year-rule"). ECHA helpdesk enquiry number: 06-0000024807-62-0000. The full study report is not available. The test was performed according to Directive 67/548/EEC requirements and GLP.

Data source

Reference
Reference Type:
other: Body responsible of the test
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: OECD 482 (Unscheduled DNA synthesis)
GLP compliance:
yes
Type of assay:
other: Unscheduled DNA synthesis, mammalian cells in vitro.

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
402-130-7
EC Name:
-
Cas Number:
106246-33-7
Molecular formula:
C21 H28 Cl2 N2
IUPAC Name:
4,4'-Methylene-bis-(3-chloro-2,6-diethylaniline)

Method

Species / strain
Species / strain / cell type:
mammalian cell line, other: Rat hepatocytes
Test concentrations with justification for top dose:
Concentration range in the main test (without metabolic activation): 2...100 µg/ml
Vehicle / solvent:
Dimethylsulphoxide (DMSO)
Details on test system and experimental conditions:
Exposure period (without metabolic activation): 18 hours
Fixation time: 18 hours

Results and discussion

Test resultsopen allclose all
Species / strain:
other: as specified above
Metabolic activation:
without
Genotoxicity:
negative
Remarks:
see the comments in the box "overall remarks"
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
more than 700 µg/ml
Species / strain:
other: as specified above
Metabolic activation:
without
Genotoxicity:
negative
Remarks:
see the comments in the box "overall remarks"
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
60 µg/ml
Remarks on result:
other: other: preliminary test
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative without metabolic activation