Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information
Read-across from a supporting study with Sodium aluminum silicate (NAS) as surrogate showed no mutagenic activity in standard test systems under valid test conditions.
Link to relevant study records
Reference
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)
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
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)
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
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
Conclusions:
Interpretation of results (migrated information):
negative

Substance (surrogate) shows no genetic toxicity in the Ames test.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Justification for classification or non-classification

see Short description of key information.