Registration Dossier
Registration Dossier
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EC number: 204-586-0 | CAS number: 122-96-3
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- other: HPV report
- Title:
- Unnamed
- Year:
- 2 003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Piperazine-1,4-diethanol
- EC Number:
- 204-586-0
- EC Name:
- Piperazine-1,4-diethanol
- Cas Number:
- 122-96-3
- Molecular formula:
- C8H18N2O2
- IUPAC Name:
- 1,4-Bis(2-hydroxyethyl)piperazine
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- bacteria, other: Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537 and E. coli strain WP2 uvrA
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- 100, 333, 1000, 3333 and 5000 ug/plate
Controls
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- methylmethanesulfonate
- other: 2 -aminoanthracene
Results and discussion
Test results
- Key result
- Species / strain:
- other: Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537 and E. coli strain WP2 uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Based on the Ames test, DiHEP was not mutagenic, in any strain with or without metabolic activation.
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