Castor oil, ester with sorbitol

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Genetic mutation in vitro;

The read across substances share high similarity in structure and functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for test substance. Experimental data from read across chemical have been reviewed to determine the mutagenic nature of Castor oil, ester with sorbitol (97488-70-5).The studies are as mentioned below

The read across substances share high similarity in functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for test substance. Genetic toxicity in vitro study was assessed for test chemical. The test material was exposed to Salmonella typhimurium TA97A and TA102 in the presence and absence of metabolic activation S9. The concentration of test material used in the presence and absence of metabolic activation were0, 0.5-50 mg/plate. No mutagenic effects were observed in both strains, in the presence and absence of metabolic activation. Therefore test chemical was considered to be non mutagenic in Salmonella typhimurium TA97A and TA102 by AMES test. Hence the substance cannot be classified as gene mutant in vitro. 

The read across substances share high similarity in functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for target substance. Bacterial reverse mutation assay was performed to evaluate the mutagenic nature of test chemical. The study was performed using Salmonella typhimurium TA98, TA100, TA1535, TA1537 and Escherichia coli WP2 uvrA with and without S9 metabolic activation system up to the limit of solubility. Test chemical failed to induce mutation in Salmonella typhimurium TA98, TA100, TA1535, TA1537 and Escherichia coli WP2uvrA in the presence and absence of S9 metabolic activation system and hence is not likely to classify as a gene mutant in vitro.

The data available for the target chemical based on its read across substance and applying weight of evidence Castor oil, ester with sorbitol (97488-70-5) does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant in vitro.

Link to relevant study records

Reference

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data for the target chemical is summarized based on the structurally similar read across chemicals

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Principles of method if other than guideline:

WoE derived based on the experimental data from structurally and functionally similar read across chemicals for the target chemical.

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Specific details on test material used for the study:

- Name of test material : Castor oil, ester with sorbitol
- Molecular formula : C75H140O27
- Molecular weight : 1473.89 g/mol
- Smiles notation : CCCCCCC(CC=CCCCCCCCC(=O)OCC(COC(=O)CCCCCCCC=CCC(CCCCCC)OOCC(O)C(O)C(O)C(O)CO)OC(=O)CCCCCCCC=CCC(CCCCCC)OOCC(O)C(O)C(O)C(O)CO)OOCC(O)C(O)C(O)C(O)CO
- Substance type : Organic
- Physical state : Liquid

Target gene:

Histidine

Species / strain / cell type:

S. typhimurium, other: TA97A and TA102

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

not specified

Species / strain / cell type:

S. typhimurium, other: TA98, TA100, TA1535, TA1537 and Escherichia coli WP2uvrA

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

not specified

Cytokinesis block (if used):

not specified

Metabolic activation:

with and without

Metabolic activation system:

Rat liver, induced with AROCLOR 1254

Test concentrations with justification for top dose:

1,0, 0.5-50 mg/plate
2.Up to limit of soulubility

Vehicle / solvent:

1.Distilled water
2,Not specified

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

not specified

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

not specified

True negative controls:

not specified

Positive controls:

not specified

Details on test system and experimental conditions:

1,METHOD OF APPLICATION: Preincubation method
2,Not specified

Rationale for test conditions:

Not specified

Evaluation criteria:

1.Histidine revertants colonies were observed
2,The plates were observed for a dose dependent increase in the number of revertants

Statistics:

not specified

Species / strain:

S. typhimurium, other: TA97A and TA102

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

Species / strain:

S. typhimurium, other: TA98, TA100, TA1535, TA1537 and Escherichia coli WP2uvrA

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: No mutagenic effct were observed

Conclusions:

Gene mutation toxicity study for Castor oil, ester with sorbitol (97488-70-5)as predicted using data from read across chemicals for Salmonella typhimurium bacterial strains in the presence and absence of S9 metabolic activation system is negative and hence the chemical is not likely to classify as a gene mutant in vitro.

Executive summary:

Genetic mutation in vitro;

The read across substances share high similarity in structure and functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for test substance. Experimental data from read across chemical have been reviewed to determine the mutagenic nature of Castor oil, ester with sorbitol (97488-70-5).The studies are as mentioned below

The read across substances share high similarity in functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for test substance. Genetic toxicity in vitro study was assessed for test chemical. The test material was exposed to Salmonella typhimurium TA97A and TA102 in the presence and absence of metabolic activation S9. The concentration of test material used in the presence and absence of metabolic activation were0, 0.5-50 mg/plate. No mutagenic effects were observed in both strains, in the presence and absence of metabolic activation. Therefore test chemical was considered to be non mutagenic in Salmonella typhimurium TA97A and TA102 by AMES test. Hence the substance cannot be classified as gene mutant in vitro. 

The read across substances share high similarity in functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for target substance. Bacterial reverse mutation assay was performed to evaluate the mutagenic nature of test chemical. The study was performed using Salmonella typhimurium TA98, TA100, TA1535, TA1537 and Escherichia coli WP2 uvrA with and without S9 metabolic activation system up to the limit of solubility. Test chemical failed to induce mutation in Salmonella typhimurium TA98, TA100, TA1535, TA1537 and Escherichia coli WP2uvrA in the presence and absence of S9 metabolic activation system and hence is not likely to classify as a gene mutant in vitro.

 The data available for the target chemical based on its read across substance and applying weight of evidence Castor oil, ester with sorbitol (97488-70-5) does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant in vitro.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Genetic mutation in vitro;

The read across substances share high similarity in structure and functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for test substance. Experimental data from read across chemical have been reviewed to determine the mutagenic nature of Castor oil, ester with sorbitol (97488-70-5).The studies are as mentioned below

The read across substances share high similarity in functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for test substance. Genetic toxicity in vitro study was assessed for test chemical. The test material was exposed to Salmonella typhimurium TA97A and TA102 in the presence and absence of metabolic activation S9. The concentration of test material used in the presence and absence of metabolic activation were0, 0.5-50 mg/plate. No mutagenic effects were observed in both strains, in the presence and absence of metabolic activation. Therefore test chemical was considered to be non mutagenic in Salmonella typhimurium TA97A and TA102 by AMES test. Hence the substance cannot be classified as gene mutant in vitro. 

The read across substances share high similarity in functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for target substance. Bacterial reverse mutation assay was performed to evaluate the mutagenic nature of test chemical. The study was performed using Salmonella typhimurium TA98, TA100, TA1535, TA1537 and Escherichia coli WP2 uvrA with and without S9 metabolic activation system up to the limit of solubility. Test chemical failed to induce mutation in Salmonella typhimurium TA98, TA100, TA1535, TA1537 and Escherichia coli WP2uvrA in the presence and absence of S9 metabolic activation system and hence is not likely to classify as a gene mutant in vitro.

 The data available for the target chemical based on its read across substance and applying weight of evidence Castor oil, ester with sorbitol (97488-70-5) does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant in vitro.

Justification for classification or non-classification

Thus based on the above annotation and CLP criteria for target substance Castor oil, ester with sorbitol (97488-70-5)does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant in vitro.