Registration Dossier
Registration Dossier
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EC number: 203-868-0 | CAS number: 111-42-2
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: 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:
- 1 985
- Bibliographic source:
- Mutat. Res., 153, 57-77
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- 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 substance name:
- 2,2'-iminodiethanol
- EC Number:
- 203-868-0
- EC Name:
- 2,2'-iminodiethanol
- Cas Number:
- 111-42-2
- Molecular formula:
- C4H11NO2
- IUPAC Name:
- 2,2'-iminodiethanol
- Details on test material:
- - Name of test material (as cited in study report): Diethanolamine
- Lot/batch No.: 17584,
- purity: 99.7%
Constituent 1
Method
- Target gene:
- histidine operon
Species / strainopen allclose all
- Species / strain / cell type:
- other: Escherichia coli WP2 and WP2uvrA
- Species / strain / cell type:
- S. typhimurium, 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:
- E. coli, 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:
- S. typhimurium, 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
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