2,5-xylenol

Endpoint summary

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.