Chlorbutanol

Genetic toxicity: in vitro

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:

test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference

Reference Type:

review article or handbook

Title:

Mutagenicity of cosmetics ingredients licensend by the European Communities

Author:

E. Gocke, M.-T. King, K. Eckhart, D. Wild

Year:

1981

Bibliographic source:

Mutation Research, 90 (1981) 91-109

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Test were performed according to standard procedures.

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Chlorbutanol

EC Number:

200-317-6

EC Name:

Chlorbutanol

Cas Number:

57-15-8

Molecular formula:

C4H7Cl3O

IUPAC Name:

chlorbutanol

Test material form:

solid: crystalline

Method

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Species / strain 2

Species / strain / cell type:

other: S. typhimurium TA 1538

Metabolic activation:

with and without

Metabolic activation system:

S9-Mix from Aroclor-treated rats

Test concentrations with justification for top dose:

top dose: 3600 µg/plate

Details on test system and experimental conditions:

Chlorobutanol was tested in two different media: ZLM and VB. The concentration of citrate was 3.5 higher in VB medium than ZLM medium. The concentrations of the other ions are up to 2-fold higher in VB medium.

Statistics:

Significance was calculated according to the Kastenbaum-Bowman tables.

Results and discussion

Test results

Test results 1

Key result

Species / strain:

S. typhimurium TA 98

Remarks:

in ZLM and VB medium

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Test results 2

Key result

Species / strain:

S. typhimurium TA 100

Remarks:

in ZLM and VB medium

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Test results 3

Key result

Species / strain:

S. typhimurium TA 1535

Remarks:

in VB medium

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Test results 4

Key result

Species / strain:

S. typhimurium TA 1535

Remarks:

in ZLM medium

Metabolic activation:

with

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Test results 5

Species / strain:

S. typhimurium TA 1535

Remarks:

in ZLM medium

Metabolic activation:

without

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

not specified

Test results 6

Key result

Species / strain:

S. typhimurium TA 1537

Remarks:

in ZLM and VB medium

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Test results 7

Key result

Species / strain:

S. typhimurium TA 1538

Remarks:

in ZLM and VB medium

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Applicant's summary and conclusion

Conclusions:

Very extensive and reviewed study. Materials and methods are not described in details. Nevertheless, the study is valid and sufficient for classification.

Executive summary:

Chlorobutanol and other cosmetic ingredients were tested for mutagenic effects: Ames test ( S. typhimurium TA 1535, TA 1537, TA 1538 TA 98 and TA 100), Basic test on Drosophila and the micronucleus test on mouse bone marrow. In all tests Chlorobutanol showed no mutagenic effects. Only in S. typhimurium TA 1535 in ZLM medium without metabolic activation Chlorobutanol revealed mutagenic effects. Tests with Chlorobutanol in typhimurium TA 1535 in ZLM medium with metabolic activation (S9 mix) and in VB medium with and without metabolic activation revealed no mutagenic potential. Overall and taking all results into account Chlorobutanol is not mutagenic. The positive result in S. typhimurium TA 1535 under specific conditions can be considered as false positive due to the high sensitivity of the Ames test.