1,3-Benzenedicarboxamide, 5-amino-N1,N3-bis(2,3-dihydroxypropyl)-, hydrochloride (1:1)

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in mammalian cells

Type of information:

experimental study

Adequacy of study:

key study

Study period:

January-June, 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study described in this report was conducted in compliance with the Corning Hazleton (Europe) Standard Operating Procedures and the principles of the following codes of Good Laboratory Practice.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)

GLP compliance:

yes (incl. QA statement)

Type of assay:

in vitro mammalian cell transformation assay

Test material

Test material information

Constituent 1

Reference substance name:

ABA Hydrochloride

IUPAC Name:

ABA Hydrochloride

Specific details on test material used for the study:

- Name of test material (as cited in study report): ABA-HCl
- Molecular formula (if other than submission substance):
- Molecular weight (if other than submission substance):
- Smiles notation (if other than submission substance):
- InChl (if other than submission substance):
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type:
- Physical state: Powder
- Analytical purity: ≥ 98.5%
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Isomers composition:
- Purity test date:
- Lot/batch No.: S-31308
- Expiration date of the lot/batch:
- Radiochemical purity (if radiolabelling):
- Specific activity (if radiolabelling):
- Locations of the label (if radiolabelling):
- Expiration date of radiochemical substance (if radiolabelling):
- Stability under test conditions:
- Storage condition of test material:
- Other:

Method

Species / strain

Species / strain / cell type:

mouse lymphoma L5178Y cells

Metabolic activation:

with and without

Metabolic activation system:

Phenoberbital / á-naphthoflavone-induced rat liver S9

Test concentrations with justification for top dose:

Concentration range in the main test (with metabolic activation): 231.3 ... 3700 µg/ml
Concentration range in the main test (without metabolic activation): 231.3 ... 3700 µg/ml

Results and discussion

Test results

Species / strain:

mouse lymphoma L5178Y cells

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

(> 3700 µg/ml)

Any other information on results incl. tables

Comments: I. experiment: treatment period 4 h with and without metabol. activation II. experiment: treatment period 24 h without metabol. activation.

Applicant's summary and conclusion

Conclusions:

Interpretation of results:
negative with metabolic activation
negative without metabolic activation

Conclusions:
ABA-HCl is considered to be non-mutagenic in this mouse lymphoma assay.

Executive summary:

The study was performed to investigate the potential of ABA-HCl to induce mutations at the mouse lymphoma thymidine kinase locus using the cell line L5178Y. The assay was performed in the two independent experiments, using two parallel cultures each. The first main experiment was performed with and without liver microsomal activation and a treatment period of 4hr. The second experiment was solely performed in the absence of metabolic activation with a treatment period of 24 hrs. Based upon the results of the range-finding test, the following concentrations were analysed in the main experiments: Experiment 1 (µg/ml) Without S9mix 231.3 462.5 925.0 1850.0 3700.0 With S9mix 231.3 462.5 925.0 1850.0 3700.0 Experiment 2(µg/ml) Without S9mix 231.3 462.5 925.0 1850.0 3700.0 In conclusion it can be stated that during the mutagenicity test described and under the experimental conditions reported the test item did not induce mutations in the mouse lymphoma thymidine kinase locus assay using the cell line L5178Y in the absence and presence of metabolic activation. Therefore, ABA-HCl is considered to be non-mutagenic in this mouse lymphoma assay.