2-chloroethanol

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was performed according to JETOC protocols similar to OECD471. Data from the JETOC is generally well trusted.

Data source

Reference

Reference Type:

publication

Title:

Mutagenicity Test Data of Existing Chemical Substances

Author:

JETOC

Year:

1996

Bibliographic source:

JETOC

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Principles of method if other than guideline:

The study was performed according to the guidelines of Ministery of Labour, (Japan 1979, 1985 and 1988) and Ames et al. 1975, Maron and Ames (1983) and Matsushima et al. (1980)
- duplicate plates were used instead of triplicate plates but the positive response was confirmed by a repeat experiment.

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2-chloroethanol

EC Number:

203-459-7

EC Name:

2-chloroethanol

Cas Number:

107-07-3

Molecular formula:

C2H5ClO

IUPAC Name:

2-chloroethan-1-ol

Details on test material:

2-chloroethanol
Purity: 99.2 %, Wako Pure Chem. Japan
Lot number: AWH5040

Method

Target gene:

histidine operon

Species / strain

Species / strain / cell type:

other: S. typhimurium TA 100, TA 1535, TA 98, TA 1537 and E.coli. WP2uvrA

Metabolic activation:

with and without

Metabolic activation system:

S9 mix

Test concentrations with justification for top dose:

50, 100, 200, 500, 1000, 2000, 5000 µg/plate

Vehicle / solvent:

Dimethyl sulfoxide

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

dmso

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: see table 1.

Details on test system and experimental conditions:

METHOD OF APPLICATION: preincubation

DURATION
- Preincubation period: 20 minutes
- Exposure duration: 48 hours

selection agent: histidine

NUMBER OF REPLICATIONS: duplicate

NUMBER OF CELLS EVALUATED: all colonies are counted

DETERMINATION OF CYTOTOXICITY
- Method: background lawn

Evaluation criteria:

Chemicals are considered mutagenic when a dose-related increase in revertant colony count is observed and the numer of revertant colonies per plate with the test substance is more than twice that of the negative control (solvent control) and when a reproducibility of the test result is observed.

Statistics:

None

Results and discussion

Test results

Test results 1

Species / strain:

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

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 2

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 3

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

without

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

WP2uvrA positive reponse (average of plates):

µg/plate	- S9 mix
	Experiment 1	Experiment 2
DMSO	43	50
50	44	-
100	33	-
200	45	-
500	40	45
1000	39	50
2000	65	60
3000	-	90
4000	-	114
5000	186	113
AF2	553	413

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
positive

2-chloroathanl was positive in the Ames test under the conditions of this study. WP2uvrA gave a positive response without metabolic activation. This response was confirmed by an independent repeat. All other strains were negative with and without metabolic activation.

Executive summary:

A study was performed according to JETOC protocols similar to OECD471. The study was performed according to the guidelines of Ministery of Labour, (Japan 1979, 1985 and 1988) and Ames et al. 1975, Maron and Ames (1983) and Matsushima et al. (1980). Deviation from th current OECD guideline is that duplicate plates were used instead of triplicate plates (but the positive response was confirmed by a repeat experiment). 50 -5000 µg/plate 2 -chloroethanol, solvent control and positive controls were applied with and without metabolic activation via the preincubation method to TA 100, TA 1535, TA 98, TA 1537 and WP2uvrA.

WP2uvrA gave a positive response without metabolic activation. This response was confirmed by an independent repeat. All other strains were negative with and without metabolic activation.