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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
