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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

Conclusion based on data obtained with octadecan-1-ol, ethoxylated (CAS No. 9005-00-9, EC No. 500-017-8) and considering all available data on gene mutation in bacteria in the Alcohol Ethoxylates (AE) category in a Weight-of-Evidence approach.

 

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 a Weight-of-Evidence approach.

 

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 in a Weight-of-Evidence approach.

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 bacteria
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only basic data given.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
only S. typhimurium TA98 and TA100 were used; no detailed information on experimental procedure, control substances etc. available; 1 experiment +S9 mix (plate incorporation and pre-incubation) and 1 experiment -S9 mix (plate incorporation only)
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay
Target gene:
His-operon
Species / strain / cell type:
S. typhimurium TA 98
Species / strain / cell type:
S. typhimurium TA 100
Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Test concentrations with justification for top dose:
No data
Vehicle / solvent:
No data
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:
METHOD OF APPLICATION: plate incorporation & preincubation
Species / strain:
S. typhimurium TA 98
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 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
Conclusions:
Under the conditions of the test, the test item was not mutagenic in S. typhimuirum strains TA98 and TA100 with and without metabolic activation.
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:
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 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 mammalian cells

Data on in vitro gene mutation in bacteria are available for octadecan-1-ol, ethoxylated (CAS No. 9005-00-9, EC No. 500-017-8) as well as several member substances of the Alcohol Ethoxylates (AE) category.

 

Study with octadecan-1-ol, ethoxylated (CAS No. 9005-00-9, EC No. 500-017-8)

The ability of the substance to induce gene mutation in bacteria was tested in an assay similar to OECD guideline 471 (Croda, 1995) using S. typhimurium strains TA 98 and TA100 with and without metabolic activation. No information on the tested concentrations or further details of the experiment are reported. The tester strains did not produce increases in the frequency of revertant colonies, neither in the presence nor in the absence of metabolic activation with S9 mix. The test substance is thus concluded not to be mutagenic in bacteria.

 

Studies in the AE category

Studies investigating in vitro gene mutation in bacteria are available for the following AE substances:

 

CAS No.

EC No.

Substance

Study protocol

Hazard conclusion

27252-75-1

500-058-1

Octan-1-ol, ethoxylated

OECD 471

Negative, with and without metabolic activation

68439-50-9

500-213-3

Alcohols, C12-14, ethoxylated

OECD 471

Negative, with and without metabolic activation

Similar OECD 471

Negative, with and without metabolic activation

68439-49-6

939-518-5

Alcohols, C16-18 (even numbered), ethoxylated, < 2.5 EO

OECD 471

Negative, with and without metabolic activation

9005-00-9

500-017-8

Octadecan-1-ol, ethoxylated

Similar OECD 471

Negative, with and without metabolic activation

 

Evaluation of gene mutation in bacteria as observed in studies

All available study results indicate a clear lack of mutagenic potential. No indication of an increase in revertant colony counts is observed in any study. Positive and vehicle control experiments yielded the expected results, demonstrating the adequacy of the test systems and metabolic activation systems. Based on all available data on in vitro gene mutation in bacteria in the AE category, it is predicted that the AE substances 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 are available for octadecan-1-ol, ethoxylated (CAS No. 9005-00-9, EC No. 500-017-8). In order to assess cytogenicity / chromosome aberration, a study in the database of the AE category is considered in a read-across approach. An adequate and reliable study investigating in vitro cytogenicity / chromosome aberration in mammalian cells within the AE category is available for alcohols, C16-18 (even numbered), ethoxylated, < 2.5 EO (CAS No. 68439-49-6, EC No. 939-518-5). The study demonstrates the lack of a clastogenic potential. Based on the study, it is concluded that the AE substances are not clastogenic in mammalian cells.

This evaluation is used for the hazard assessment and to conclude on the 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 are available for octadecan-1-ol, ethoxylated (CAS No. 9005-00-9, EC No. 500-017-8). In order to assess gene mutation in mammalian cells, a study in the database 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 alcohols, C16-18 (even numbered), ethoxylated, < 2.5 EO (CAS No. 68439-49-6, EC No. 939-518-5). The study demonstrates the lack of a mutagenic potential. Based on the study, it is concluded that the AE substances are not mutagenic in mammalian cells.

This evaluation is used for the hazard assessment and to conclude on the 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 octadecan-1-ol, ethoxylated (CAS No. 9005-00-9, EC No. 500-017-8) and with other 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.