3-chloropropane-1,2-diol

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable deviations, no information on GLP

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1988

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

fifth required strain was not tested

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

3-chloropropane-1,2-diol

EC Number:

202-492-4

EC Name:

3-chloropropane-1,2-diol

Cas Number:

96-24-2

Molecular formula:

C3H7ClO2

IUPAC Name:

3-chloropropane-1,2-diol

Details on test material:

- Name of test material (as cited in study report): 3-Chloro-1,2-propanediol
- Analytical purity: 99+ %
- Source: Aldrich Chemical
Detailed information on the test substance was supplied by NTP chemical repository (Radian Corp., Austin, TX, USA) to the testing labs, but did not appear in the publication

Method

Target gene:

Histidine gene

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 98

Additional strain / cell type characteristics:

not applicable

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 100

Additional strain / cell type characteristics:

not applicable

Species / strain 3

Species / strain / cell type:

S. typhimurium TA 1535

Additional strain / cell type characteristics:

not applicable

Species / strain 4

Species / strain / cell type:

S. typhimurium TA 97

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

10% Aroclor 1254-induced rat and hamster liver S-9 mix

Test concentrations with justification for top dose:

All strains: (100, 333, 1000, 3333, 10000) µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: distilled water

Controls

Controls 1

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

Migrated to IUCLID6: TA1535 and TA100, no metabolic activation

Controls 2

Positive control substance:

9-aminoacridine

Remarks:

Migrated to IUCLID6: TA97 and TA1537, no metabolic activation

Controls 3

Positive control substance:

other: 4-nitro-o-phenylenediamine, TA 98, no metabolic activation

Controls 4

Positive control substance:

other: 2-aminoanthracene, all strains, with metabolic activation

Details on test system and experimental conditions:

METHOD OF APPLICATION: preincubation


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


NUMBER OF REPLICATIONS: At least 5 doses were tested in triplicate. Experiments were repeated at least 1 week after the initial trial.


DETERMINATION OF CYTOTOXICITY
- Method: the reduction of the bacterial background lawn and/or reduction of the his+ colonies


OTHER EXAMINATIONS: precipitation of the test substance

Evaluation criteria:

A chemical was judged mutagenic (+) or weakly mutagenic (W+) if it produced a reproducible dose-related response over the solvent control in replicate trials

Statistics:

no data

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Test results 2

Species / strain:

S. typhimurium TA 98

Metabolic activation:

without

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Test results 3

Species / strain:

S. typhimurium TA 97

Metabolic activation:

with

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Test results 4

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

other: slight clearing of background lawn at highest test conc. in the absence of S9

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Test results 5

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Applicant's summary and conclusion

Conclusions:

The substance was considered mutagenic