Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Regarding genetic toxicity, two publication dealing with in vitro studies (Ames tests) for the test item are available. The test item was found to be negative for in vitro genotoxicity in both studies.

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
Study period:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions, limited documentation
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
Only 4 strains of S. typhimurium and no E. coli strain were tested Test design in accordance with B.N. Ames, J. McCann and E. Yamasaki, Mutat. Res., 31 (1975) 347.
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
S9-Mix from Aroclor 1254 or 3-methylcholantrene induced rats
Test concentrations with justification for top dose:
The subctance was tested at 3 µmol/plate.
Vehicle / solvent:
Ethanol was used as vehicle
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
N-ethyl-N-nitro-N-nitrosoguanidine
other: 2-aminoanthracene (with metabolic activation)
Remarks:
N-ethyl-N-nitro-N-nitrosoguanidine used without metabolic activation
Details on test system and experimental conditions:
The experiments were carried out essentially as described by Ames (1975) and using the spot test.

The substance was tested at 3 μmol/plate. In absence of a background lawn of bacteria on the plates ( indicating toxicity) the test would have been repeated with a lower concentration of the substance.

The following controls were made :
- the viable count was determined;
- the number of spontaneous revertants was measured;
- the presence of the rfa-mutation was checked by crystal violet inhibition;
- the presence of the plasmid pKM 101 in strains TA 98 and TA 100 was checked by resistance to ampicillin;
- the response to the positive controls N-methylN'-nitroN-nitrosoguanidin (not requiring metabolic activation) and 2-aminoanthracene (requiring activation) was checked
Evaluation criteria:
Not decribed by the authors.
Statistics:
No statistics were performed.
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.
Conclusions:
Interpretation of results (migrated information):
negative
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Additional information from genetic toxicity in vitro:

Florin, (1980):

In an Ames test the test item was tested at one concentration of 3 μmol/plate in spot tests using the strains TA 98, TA 100, TA 1535, and TA 1537 with and without S-9 from Aroclor-induced rats. The test item was found to be not mutagenic with and without metabolic activation.

Hejtmnakova, (1979):

The mutagenic activity of the test item at 0.5 % in ethanol was investigated with the Ames test on eight strains of Salmonella typhimirium: TA 100 ; TA 1530 ; TA 1535 ; TA 1538 ; TA 1950 ; TA 1951 ; TA 1952: G 46 without metabolic activation. The test item did not show any mutagenic activity in the Ames test (spot-test).


Justification for classification or non-classification

Based on the available data, the test item is not subject for classification and labelling according to Regulation (EC) No 1272/2008.