Pentaboron sodium octaoxide

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro cytogenicity / chromosome aberration study in mammalian cells

Type of information:

experimental study

Adequacy of study:

key study

Study period:

No data

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevent results.

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1987

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: Carried out to an internal NTP protocol, which generally complies with OECD guidelines.

Deviations:

not applicable

Principles of method if other than guideline:

Although this was carried out to an internal NTP protocol, it generally complies with OECD guidelines. Other literature data confirm the results. Also based on Galloway et al; 1985.

GLP compliance:

yes

Type of assay:

in vitro mammalian chromosome aberration test

Test material

Test material information

Constituent 1

Reference substance name:

Boric acid

EC Number:

233-139-2

EC Name:

Boric acid

Cas Number:

10043-35-3

Molecular formula:

H3BO3

IUPAC Name:

Boric acid

Details on test material:

- Name of test material: Boric acid (Purity 99.7 %)

Method

Target gene:

Not applicable

Species / strain

Species / strain / cell type:

Chinese hamster Ovary (CHO)

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

S9 mix - Aroclor 1254 induced rat (Sprague-Dawley) liver S9 fraction

Test concentrations with justification for top dose:

With S-9: 500, 1000, 1500 and 2000 μg/mL.
Without S-9: 1000, 1600, 2000 and 2500 μg.

Vehicle / solvent:

Water

Controls

Controls 1

Positive controls:

yes

Positive control substance:

mitomycin C

Controls 2

Positive controls:

yes

Positive control substance:

cyclophosphamide

Details on test system and experimental conditions:

METHOD OF APPLICATION: In water
NUMBER OF CELLS EVALUATED: Not stated

Results and discussion

Test results

Species / strain:

Chinese hamster Ovary (CHO)

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Applicant's summary and conclusion

Conclusions:

Test substance is non genotoxic.