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Toxicological information

Genetic toxicity: in vitro

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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: Acceptable, well-documented study which meets basic scientific principles

Data source

Reference
Reference Type:
publication
Title:
Genetic toxicology testing of 41 industrial chemicals
Author:
Dean BJ, et al.
Year:
1985
Bibliographic source:
Mutat. Res., 153, 57-77

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
only tested up to 4000 µg/plate
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Diethanolamine
- Lot/batch No.: 17584,
- purity: 99.7%

Method

Target gene:
histidine operon
Species / strainopen allclose all
Species / strain / cell type:
other: Escherichia coli WP2 and WP2uvrA
Species / strain / cell type:
other: TA 1535, TA 1537, TA 1538, TA98, TA100
Metabolic activation:
with and without
Metabolic activation system:
rat liver S9 mix (Aroclor 1254 induced)
Test concentrations with justification for top dose:
125, 250, 500, 1000, 2000, 4000 µg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: water
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: benzo(a)pyrene, ethylmethanesulphonate, methylmethanesulfonate, cyclophosphamide
Details on test system and experimental conditions:
METHOD OF APPLICATION: in medium; in agar (plate incorporation); preincubation; as impregnation on paper disk (all applications investigated)

DURATION
- Preincubation period: 30 min

NUMBER OF REPLICATIONS: at least 3 plates per data point


Results and discussion

Test resultsopen allclose all
Species / strain:
other: Escherichia coli WP2 and WP2uvrA
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Species / strain:
other: TA 1535, TA 1537, TA 1538, TA98, TA100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Data given in tabular form. Individual results were not supplied.

Applicant's summary and conclusion