Benzyl 4-hydroxybenzoate

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

The test substance, Benzyl 4-hydroxybenzoatel, was estimated to be negative for gene mutation in an Ames test on S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Link to relevant study records

Reference

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

calculation (if not (Q)SAR)

Remarks:

Migrated phrase: estimated by calculation

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Data is from modelling database developed by the National Food Institute, Technical University of Denmark.

Qualifier:

according to guideline

Guideline:

other:

Principles of method if other than guideline:

estimation

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

not specified

True negative controls:

not specified

Positive controls:

not specified

Positive control substance:

not specified

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:

not specified

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicability domain: In domain

Conclusions:

Interpretation of results (migrated information):
negative

The test substance, Benzyl 4-hydroxybenzoatel, was estimated to be negative for gene mutation in an Ames test on S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Executive summary:

The test substance,Benzyl 4-hydroxybenzoate, was estimated to be negative for gene mutation in an Ames test on S. typhimurium TA 1535, TA 1537, TA 98 and TA 100. Thus it can be concluded that the substanceBenzyl 4-hydroxybenzoatehas negative genetic toxicity effects and based on the CLP criteria for classification it can be classified as not genotoxic.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

Various studies were reviewed and from read across data, the effect of the test compound on Gene toxicity. These are summarized as follows:

 

The test substance, Benzyl 4-hydroxybenzoatel, was estimated to be negative for gene mutation in an Ames test on S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

The test substance,Benzyl 4-hydroxybenzoate, was estimated to be negative for gene mutation in an Ames test on S. typhimurium TA 1535, TA 1537, TA 98 and TA 100. Thus it can be concluded that the substanceBenzyl 4-hydroxybenzoatehas negative genetic toxicity effects and based on the CLP criteria for classification it can be classified as not genotoxic.

Benzyl salicylate failed to induce mutation in the S. typhimurium tester strains TA 1535, TA 1537, TA 98 and TA 100 and hence is negative for mutation in vitro.

Salmonella/microsome test in the absence of exogenous metabolic activation and in the presence of liver S-9 from Aroclor-induced male Sprague-Dawley rats and Syrian hamsters was performed to evaluate the mutagenic nature of the test compound Benzyl salicylate.

 

The test compound was used at a dosage level of 0, 0.3, 1, 3.3, 10, 20, 33, 100, 333 and 666 µg/plate in the preincubation assay of 48 hrs.

Benzyl salicylate failed to induce mutation in theS. typhimuriumtester strains TA 1535, TA 1537, TA 98 and TA 100 and hence is negative for mutation in vitro.

 

Benzyl salicylate failed to induce mutation in the S. typhimurium tester strains TA 1535, TA 1537, TA 98 and TA 100 and hence is negative for mutation in vitro.

Salmonella/microsome test in the absence of exogenous metabolic activation and in the presence of liver S-9 from Aroclor-induced male Sprague-Dawley rats and Syrian hamsters was performed to evaluate the mutagenic nature of the test compound Benzyl salicylate. The test compound was used at a dosage level of 0, 3.3, 10, 33, 100, 333 µg/plate in the preincubation assay of 48 hrs.

Benzyl salicylate failed to induce mutation in theS. typhimuriumtester strains TA 1535, TA 1537, TA 98 and TA 100 and hence is negative for mutation in vitro.

Justification for selection of genetic toxicity endpoint

The test substance,Benzyl 4-hydroxybenzoate, was estimated to be negative for gene mutation in an Ames test on S. typhimurium TA 1535, TA 1537, TA 98 and TA 100. Thus it can be concluded that the substanceBenzyl 4-hydroxybenzoatehas negative genetic toxicity effects and based on the CLP criteria for classification it can be classified as not genotoxic.

Justification for classification or non-classification

According to new CLP regulation classification criteria and based on the gene toxicity, it is concluded that the substance benzylparaben (CAS No 94-18-8) is not classified for gene toxicity.