Hexacalcium hexaoxotris[sulphato(2-)]dialuminate(12-)

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

Study period:

16. 12. 2009 - 16. 03.2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-Study according to OECD guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

12252-12-9

Cas Number:

12252-12-9

IUPAC Name:

12252-12-9

Constituent 2

Reference substance name:

Ettringite

IUPAC Name:

Ettringite

Constituent 3

Reference substance name:

Aluminium calcium hydroxid sulfate hexacosahydrat

IUPAC Name:

Aluminium calcium hydroxid sulfate hexacosahydrat

Details on test material:

- Name of test material (as cited in study report): Casul-Pulver getrocknet (Ettringit)
- Chemical name: Aluminium calcium hydroxid sulfate hexacosahydrat (Ca6[Al(OH)6]2(SO4)3.26H2O)
- Substance type: white powder
- Physical state: solid
- Analytical purity: 98%
- Lot/batch No.: R-CL250609
- Expiration date of the lot/batch: 25.06.2011
- Storage condition of test material: room temperature

Method

Species / strain

Species / strain / cell type:

S. typhimurium, other: Strains TA 1535, TA 97a, TA 98, TA 100, and TA 102 with and without S9 Mix over 48 hours in concentrations from 50 to 5050 µg/plate

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

S9 produced from rat livers of male Sprague-Dawley rat which were treated with 500 mg Aroclor 1254/kg body weight intraperitoneally

Test concentrations with justification for top dose:

from 50 to 5050 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: deionised water
- Justification for choice of solvent/vehicle: The test item was not sufficiently soluble in the accepted solvents for the Ames-Test. Therefore suspensions were prepared. The test item was autoclaved (121 °C, 2 bar) and suspended in deionised water

Details on test system and experimental conditions:

METHOD OF APPLICATION: in medium; in agar (plate incorporation); preincubation; in suspension; as impregnation on paper disk

DURATION
- Preincubation period: yes
- Exposure duration: 48 h

Evaluation criteria:

number of revertant colonies

Statistics:

mean of 4 values

Results and discussion

Test results

Species / strain:

S. typhimurium, other: TA 1535, TA97a, TA98, TA 100, TA 102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

The test item is not mutagenic.

Executive summary:

Casul-Pulver getrocknet (Ettringite) was tested in 2 series in the Bacterial Reverse Mutation Test according to OECD Guideline 471 with the strains TA 1535, TA 97a, TA 98, TA 100, and TA 102 with and without S9 Mix over 48 hours in concentrations from 50 to 5050 µg/plate.

The testarticle was suspended in deionised water. None of the concentrations caused a significant increase in the number of revertant colonies.

No signs of toxicity towards the bacteria were observed.

The test item Casul-Pulver getrocknet (Ettringite) is not mutagenic in the Bacerial Reverse Mutation Test.