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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
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:
Mutagenicity of cosmetic ingredients licensed by the European Communities
Author:
Gocke E, King M-T, Eckhardt K, Wild D
Year:
1981
Bibliographic source:
Mutat Res 90, 91-109

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Dichloromethane
EC Number:
200-838-9
EC Name:
Dichloromethane
Cas Number:
75-09-2
Molecular formula:
CH2Cl2
IUPAC Name:
dichloromethane
Details on test material:
Dichloromethane was obtained from Merck Co., Darmstadt, Germany. The compound was checked for correct melting point and elementary analysis.

Method

Target gene:
his
Species / strain
Species / strain / cell type:
S. typhimurium, other: TA98, TA100, TA1535, TA1537, TA 1538
Metabolic activation:
with and without
Metabolic activation system:
S9 from Aroclor-pretreated rats
Test concentrations with justification for top dose:
125, 250, 500, and 750 μl in a 9 litre desiccator
Vehicle / solvent:
None
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
no
True negative controls:
no
Positive controls:
no
Details on test system and experimental conditions:
Because of the volatility of the compound the petri dishes were placed in airtight desiccators for 8 h. Substance was tested in Vogel-Bonner medium.
Evaluation criteria:
Not specified.
Statistics:
Not specified.

Results and discussion

Test results
Species / strain:
S. typhimurium, other: TA98, TA100
Metabolic activation:
with and without
Genotoxicity:
positive
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
The test substance was active in strains TA98 and TA100 with and without metabolic activation. In the figure below , increases up ca. 10-fold above control were noted in both strains. The increase was statistically significant (p<=0.01).

Any other information on results incl. tables

No data in table form were available, but a figure was included instead (see below).

Figure: results of the Ames test. Ordinate: His+ revertants per plate of the indicated strain(s), viz bullet = TA98 and triangle = TA100; abscissa: uL in 9 -L desiccator; closed symbol: in presence of S9 -mix, open symbol: without S9 -mix.

Applicant's summary and conclusion

Conclusions:
The test substance was active in strains TA98 and TA100 with and without metabolic activation.