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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Eicosanoic acid was found to be non-genotoxic.

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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Reference:
Composition 0
Qualifier:
according to
Guideline:
other: Modelling database
Principles of method if other than guideline:
Multicase model A2H
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay
Test material information:
Composition 1
Species / strain:
other: Salmonella sp.
Additional strain characteristics:
not specified
Metabolic activation:
not specified
Metabolic activation system:
no data
Species / strain:
other: Salmonella sp.
Metabolic activation:
not specified
Genotoxicity:
negative
Cytotoxicity:
not specified
Vehicle controls valid:
not specified
Negative controls valid:
not specified
Positive controls valid:
not specified
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.
Conclusions:
Interpretation of results (migrated information):
negative

Based on the prediction for in-vitro bacterial reverse mutation assay test on Salmonella typhimurium sp. it was estimated that Eicosanoic acid does not exhibit positive gene mutation effect.
Executive summary:

Based on the prediction for in-vitro bacterial reverse mutation assay test on Salmonella typhimurium sp. it was estimated that Eicosanoic acid does not exhibit positive gene mutation effect.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

Various studies were reviewed for genetic toxicity from reliable sources having Klimish rating 2 and 4 for the target and the read across substance for CAS: 506-30-9 considering the weight of evidence approach.

The summary of the results are presented below

 Sr.No

Endpoint

Interpretation of Results

Species/Strain

Conclusion

Sources

1

In vitro Genetic toxicity

Negative

S. typhimurium Sp.

Based on the prediction for in-vitro bacterial reverse mutation assay test on Salmonella typhimurium species it was estimated that Eicosanoic acid does not exhibit positive gene mutation effect.

Predicted data for CAS : 506-30-9

2

Chromosome aberration

Negative

Chinese hamster Ovary (CHO)

Based on the prediction for in vitro mammalian chromosome aberration test on Chinese hamster Ovary (CHO) it was estimated that Eicosanoic acid does not exhibit positive chromosomal effect. 

Predicted data for CAS : 506-30-9

3

Chromosome aberration

Negative

Chinese hamster Ovary (CHO K1)

Based on the data for in vitro mammalian chromosome aberration test on Chinese hamster Ovary (CHO K1) cells it was found that Eicosanoic acid does not exhibit positive chromosomal and cytotoxic effect .

Publication data for CAS : 506-30-9

4

In vitro Genetic toxicity

Negative with and without metabolic activation

Salmonella typhimurium strains TA100 , TA104 ,TA 1535, TA 97 and TA 98

In an Ames test , stearic acid, in dimethyl sulfoxide from doses 10 - 10000 µg/plate was not mutagenic in Salmonella typhimurium strains TA100 , TA104 , TA 1535, TA 97 and TA 98 with and without addition of S9 liver microsome fractions from Aroclor induced rats.The same has been obtained for hamsters as well.

Publication data for RA CAS : 57-11-4

 

Based on the above results it can be concluded that substance CAS: 506-30-9 is expected to show the similar toxicological effect based on the effects observed on the other category members. Thus it is concluded that the substance is non-genotoxic. Thus Eicosanoic acid is considered to be non-mutagenic as the per the CLP regulation.

Justification for selection of genetic toxicity endpoint

Based on the prediction for in-vitro bacterial reverse mutation assay test on Salmonella typhimurium it was estimated that Eicosanoic acid does not exhibit positive gene mutation effect.Also the prediction for chromosomal abberation Based on in vitro mammalian chromosome aberration test on Chinese hamster Ovary (CHO)  was estimated that Eicosanoic acid does not exhibit positive chromosomal effect .

Justification for classification or non-classification

Eicosanoic acid is considered to be non-mutagenic as the per the CLP regulation.