2-butoxyethyl acetate

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:

before 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Published study but containing sufficient details to be able to judge it reliable for hazard assessment. Part of a programme of work by the NTP. Data tables available for results. TA102 not included. Full documentation in NTP studies available. Read-across based on supporting substance (analogue approach). The data in this record is for the metabolite 2-butoxyethanol (CAS; 111-76-2, EC no 203-905-0) for which the systemic toxicity will be the same. Full details of the justification for the use of an analogue for this end point are included in the document appended to chapter 13 of this dossier.

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Unnamed

Year:

1992

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

2000

Reference 3

Reference Type:

publication

Title:

Unnamed

Year:

1993

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

Remarks:

, no significant deviations noted

Principles of method if other than guideline:

Preincubation as per method of Haworth (Env Mutagen, 5 suppl 1, 3-142, 1983)

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2-butoxyethanol

EC Number:

203-905-0

EC Name:

2-butoxyethanol

Cas Number:

111-76-2

Molecular formula:

C6H14O2

IUPAC Name:

2-butoxyethanol

Details on test material:

Substance described as purest commercial material available, but no further data.

Method

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535

Details on mammalian cell type (if applicable):

- Type and identity of media:
- Culture prepared at 37C overnight with shaking in Oxoid #2 broth or in defined minimal medium supplemented with biotin and histidine. Phenotype analysed at time of use.

Additional strain / cell type characteristics:

not applicable

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 97

Details on mammalian cell type (if applicable):

- Type and identity of media:
- Culture prepared at 37C overnight with shaking in Oxoid #2 broth or in defined minimal medium supplemented with biotin and histidine. Phenotype analysed at time of use.

Additional strain / cell type characteristics:

not applicable

Species / strain 3

Species / strain / cell type:

S. typhimurium TA 98

Details on mammalian cell type (if applicable):

- Type and identity of media:
- Culture prepared at 37C overnight with shaking in Oxoid #2 broth or in defined minimal medium supplemented with biotin and histidine. Phenotype analysed at time of use.

Additional strain / cell type characteristics:

not applicable

Species / strain 4

Species / strain / cell type:

S. typhimurium TA 100

Details on mammalian cell type (if applicable):

- Type and identity of media:
- Culture prepared at 37C overnight with shaking in Oxoid #2 broth or in defined minimal medium supplemented with biotin and histidine. Phenotype analysed at time of use.

Additional strain / cell type characteristics:

not applicable

Species / strain 5

Species / strain / cell type:

S. typhimurium TA 1537

Details on mammalian cell type (if applicable):

- Type and identity of media:
- Culture prepared at 37C overnight with shaking in Oxoid #2 broth or in defined minimal medium supplemented with biotin and histidine. Phenotype analysed at time of use.

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254 induced male SD rat and male Syrian hamster liver S9 fraction, each used at two concentrations (10% and 30%)

Test concentrations with justification for top dose:

100, 333, 1000, 3333, 10000 ug/plate

Vehicle / solvent:

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: used for TA1535 and TA100 without metabolic activation

Controls 2

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

Migrated to IUCLID6: used for TA97 without metabolic activation

Controls 3

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 4-nitro-o-phenylenediamine used for TA98 without metabolic activation

Controls 4

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene for all strains with metabolic activation

Details on test system and experimental conditions:

METHOD OF APPLICATION: preincubation

DURATION
- Preincubation period: 20 mins at 37C
- Expression time (cells in growth medium): 2 days at 37C

NUMBER OF REPLICATIONS: 3

DETERMINATION OF CYTOTOXICITY
- Dose range for main test assessed using TA100. Toxic concentrations defined as those producing a decrease in the background number of his+ colonies and/or a clearing in the background lawn. If no toxicity was seen, the maximum dose tested was 10000ug/plate

Evaluation criteria:

Only considered non mutagenic if negative in all strains with and without activation and with both S9 extracts at both concentrations

Statistics:

no data

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

Remarks:

up to maximum dose tested (10000ug/plate)

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 97

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

ADDITIONAL INFORMATION ON CYTOTOXICITY: some evidence of cytotoxicity at top dose in TA100 and TA98.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

There was no evidence of mutagenicity in any of the strains tested in the absence of metabolic activation and in the presence of either of the metabolic activation extracts, rat or hamster, at either of the concentrations tested.

Executive summary:

In a reverse mutation assay in bacteria strains TA97, TA98, TA100, TA1535 and TA1537 using the substance 2 -butoxyethanol there was no evidence of mutation with and without metabolic activation systems derived from two species (rat and hamster) used at two different concentrations. These results can be extrapolated to the acetate ester of this substance.