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Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

In vitro gene mutation in bacteria: negative with and without metabolic activation

Read-across based on grouping of substances (category approach) considering all available data on gene mutation in bacteria in the Alcohol Ethoxylates (AE) category.

In vitro cytogenicity / chromosome aberration in mammalian cells: negative with and without metabolic activation

Read-across based on grouping of substances (category approach) considering all available data on cytogenicity / chromosome aberration in mammalian cells in the AE category.

In vitro gene mutation in mammalian cells: negative with and without metabolic activation

Read-across based on grouping of substances (category approach) considering all available data on gene mutation in mammalian cells in the AE category.

Link to relevant study records

Referenceopen allclose all

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Justification for type of information:
Please refer to the category justification provided in the category object.
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid

For a detailed assessment of the potential of Alcohol Ethoxylates (AE) to induce gene mutation in bacteria, please refer to the category justification attached to the category object.

Conclusions:
Applying read-across based on grouping of substances (category approach), no potential to induce gene mutation in bacteria with and without metabolic activation is predicted for the target substance.
Executive summary:

The available data on gene mutation in bacteria in the Alcohol Ethoxylates (AE) category indicate no potential for the target substance to exhibit any mutagenic activity. As explained in the category justification, the differences in molecular structure and composition between the target substance and the members of the AE category are unlikely to lead to differences in the mutagenic potential.

Endpoint:
in vitro gene mutation study in mammalian cells
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Justification for type of information:
Please refer to the category justification provided in the category object.
Key result
Species / strain:
Chinese hamster Ovary (CHO)
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid

For a detailed assessment of the potential of Alcohol Ethoxylates (AE) to induce gene mutation in mammalian cells, please refer to the category justification attached to the category object.

Conclusions:
Applying read-across based on grouping of substances (category approach), no potential to induce gene mutation in mammalian cells with and without metabolic activation is predicted for the target substance.
Executive summary:

The available data on gene mutation in mammalian cells in the Alcohol Ethoxylates (AE) category indicate no potential for the target substance to exhibit any mutagenic activity. As explained in the category justification, the differences in molecular structure and composition between the target substance and the members of the AE category are unlikely to lead to differences in the mutagenic potential.

Endpoint:
in vitro cytogenicity / chromosome aberration study in mammalian cells
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Justification for type of information:
Please refer to the category justification provided in the category object.
Key result
Species / strain:
Chinese hamster Ovary (CHO)
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid

For a detailed assessment of the potential of Alcohol Ethoxylates (AE) to induce cytogenicity / chromosome aberration in mammalian cells, please refer to the category justification attached to the category object.

Conclusions:
Applying read-across based on grouping of substances (category approach), no potential to induce cytogenicity / chromosome aberration in mammalian cells with and without metabolic activation is predicted for the target substance.
Executive summary:

The available data on cytotoxicity / chromosome abberation in mammalian cells in the Alcohol Ethoxylates (AE) category indicate no potential for the target substance to exhibit any mutagenic activity. As explained in the category justification, the differences in molecular structure and composition between the target substance and the members of the AE category are unlikely to lead to differences in the mutagenic potential.

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

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In vitro gene mutation in bacteria

No data on in vitro gene mutation in bacteria of (Z)-9-octadecen-1-ol, ethoxylated, < 2.5 EO (CAS No. 9004-98-2, EC No. 500-016-2) are available. In order to assess gene mutation in bacteria, studies in the data pool of the Alcohol Ethoxylates (AE) category are considered in a read-across approach. As opposed to endpoints related to systemic toxicity, all AE substances contribute to the data used for read-across of genetic toxicity, incl. gene mutation in bacteria. Adequate and reliable studies investigating in vitro gene mutation in bacteria within the AE category are available for the following category member substances:

- Octan-1-ol, ethoxylated (CAS No. 27252-75-1, EC No. 500-058-1): (OECD 471) negative with and without metabolic activation in S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

- Alcohols, C12-14, ethoxylated, < 2.5 EO (CAS No. 68439-50-9, EC No. 500-213-3): (OECD 471) negative with and without metabolic activation in S. typhimurium TA 1535, TA 1537, TA 1538, TA 98 and TA 100 and (similar OECD 471) negative with and without metabolic activation in S. typhimurium TA 1535, TA 1537, TA, 1538, TA 98 and TA 100

- Alcohols, C16-18 (even numbered), ethoxylated, < 2.5 EO (CAS No. 68439-49-6, EC No. 939-518-5): (OECD 471) negative with and without metabolic activation in S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

- Octadecan-1-ol, ethoxylated, < 2.5 EO (CAS No. 9005-00-9, EC No. 500-017-8): (similar OECD 471) negative with and without metabolic activation in S. typhimurium TA 98 and TA 100

Conclusion

All available study results indicate a clear lack of mutagenic potential. No indication of an increase in revertant colony counts was observed in any study. Positive and vehicle control experiments yielded the expected results, demonstrating the adequacy of the test systems and metabolic activation. Based on all available data on in vitro gene mutation in bacteria in the AE category, it is predicted that the AE substances, incl. (Z)-9-octadecen-1-ol, ethoxylated, < 2.5 EO (CAS No. 9004-98-2, EC No. 500-016-2), are not mutagenic in bacteria either in the presence or the absence of metabolic activation.

This evaluation is considered sufficiently conclusive for the hazard assessment and classification and labelling of the AE substances. For a detailed evaluation of the genotoxic potential of the substances in the AE category, please refer to the category justification attached to the category object.

In vitro cytogenicity / chromosome aberration in mammalian cells

No data on in vitro cytogenicity / chromosome aberration in mammalian cells of (Z)-9-octadecen-1-ol, ethoxylated, < 2.5 EO (CAS No. 9004-98-2, EC No. 500-016-2) are available. In order to assess cytotoxicity / chromosome aberration, the available data in the data pool of the AE category is considered. An adequate and reliable study investigating in vitro cytogenicity / chromosome aberration in mammalian cells within the AE category is available for the following category member substance:

- Alcohols, C16-18 (even numbered), ethoxylated, < 2.5 EO (CAS No. 68439-49-6, EC No. 939-518-5): (OECD 473) negative with and without metabolic activation in Chinese hamster ovary (CHO) cells

The study demonstrates the lack of a clastogenic potential. It is concluded that AE substances, incl. (Z)-9-octadecen-1-ol, ethoxylated, < 2.5 EO (CAS No. 9004-98-2, EC No. 500-016-2), are generally not clastogenic. This evaluation is used for the hazard assessment and classification and labelling of the AE substances. For a detailed evaluation of the genotoxic potential of the substances in the AE category, please refer to the category justification attached to the category object.

In vitro gene mutation in mammalian cells

No data on in vitro gene mutation in mammalian cells of (Z)-9-octadecen-1-ol, ethoxylated, < 2.5 EO (CAS No. 9004-98-2, EC No. 500-016-2) are available. In order to assess gene mutation in mammalian cells, the available data in the data pool of the AE category is considered. An adequate and reliable study investigating in vitro gene mutation in mammalian cells within the AE category is available for the following category member substance:

- Alcohols, C16-18 (even numbered), ethoxylated, < 2.5 EO (CAS No. 68439-49-6, EC No. 939-518-5): (OECD 476) negative with and without metabolic activation in Chinese hamster ovary (CHO) cells

The study demonstrates the lack of a mutagenic potential. It is concluded that AE substances, incl. (Z)-9-octadecen-1-ol, ethoxylated, < 2.5 EO (CAS No. 9004-98-2, EC No. 500-016-2), are generally not mutagenic in mammalian cells. This evaluation is used for the hazard assessment and classification and labelling of the AE substances. For a detailed evaluation of the genotoxic potential of the substances in the AE category, please refer to the category justification attached to the category object.

Justification for classification or non-classification

The available data on genetic toxicity obtained with members of the Alcohol Ethoxylates (AE) category do not meet the criteria for classification according to the CLP Regulation (EC) No. 1272/2008 and are therefore conclusive but not sufficient for classification. Based on grouping of substances (category approach), (Z)-9-octadecen-1-ol, ethoxylated, < 2.5 EO (CAS No. 9004-98-2, EC No. 500-016-2) is predicted not to fulfil the classification criteria and is consequently not classified for genetic toxicity.