Boric acid, aluminum salt

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: Comparable to guideline study, comprehensive testing programme (NTP/USA)

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1987

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

4 instead of 5 strains

Principles of method if other than guideline:

Test protocol according to Haworth S et al. (1983): Salmonella mutagenicity results for 250 chemicals. Environ. Mutagen., 5(Suppl. 1), 3 - 142

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Silicic acid, aluminum sodium salt

EC Number:

215-684-8

EC Name:

Silicic acid, aluminum sodium salt

Cas Number:

1344-00-9

Details on test material:

- Name of test material (as cited in study report): sodium aluminosilicate
- Substance type: inorganic
- Physical state: solid

Method

Species / strain

Species / strain / cell type:

other: Salmonella typhimurium TA 98, TA100, TA1535, and TA 1537 (see Table 204 p. 95)

Metabolic activation system:

from Arochlor-1254 induced livers (male SD rat and male Syrian hamster)

Test concentrations with justification for top dose:

0, 100, 333, 1000, 3333, and 4000 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: distilled water
- Justification for choice of solvent/vehicle: used as dispersant rather than solvent (very slight water solubility)

Controls

Negative solvent / vehicle controls:

yes

Remarks:

+ distilled water

Positive controls:

yes

Positive control substance:

other: -S9: sodium azide (TA 1535, TA100); 9-aminoacridine (TA97, TA1537); 4-nitro-o-phenylenediamine (TA98) // +S9: 2-aminoanthracene (all strains)

Details on test system and experimental conditions:

METHOD OF APPLICATION: preincubation, 37 °C

DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h
- Expression time (cells in growth medium): on agar 48 h at 37°C

NUMBER OF REPLICATIONS: 3

DETERMINATION OF CYTOTOXICITY
- Method: clearing in the density of the background lawn of TA 100

Evaluation criteria:

positive: reproducible, dose-related increase over the solvent control

Results and discussion

Test results

Species / strain:

other: Salmonella typhimurium TA 98, TA100, TA1535, and TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Remarks:

Precipitation at the two highest doses

Vehicle controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

Substance (surrogate) shows no genetic toxicity in the Ames test.