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Toxicological information

Genetic toxicity: in vitro

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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:
2003

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

Constituent 1
Chemical structure
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

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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