Alcohols, C12-14, ethoxylated

Endpoint summary

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 alcohols, C12-14, ethoxylated (CAS No. 68439-50-9, EC No. 500-213-3) 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

Reference

Reference 1

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

25 Aug - 30 Sep 1996

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

adopted in 1983

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

adopted in 2020

Deviations:

yes

Remarks:

test conducted in 4 valid strains only; no historical control data provided; 2-aminoanthracene used as sole positive control for tests with S9 mix; 2 experiments performed under identical conditions

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

GLP compliance:

yes (incl. QA statement)

Remarks:

The Department of Health of the Government of the United Kingdom

Type of assay:

bacterial reverse mutation assay

Target gene:

His-operon

Species / strain / cell type:

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

Additional strain / cell type characteristics:

not applicable

Species / strain / cell type:

S. typhimurium TA 1538

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

Type and composition of metabolic activation system: Cofactor supplemented post-mitochondrial fraction (S9 mix).
- source of S9 : in house preparation
- method of preparation of S9 mix: S9 fraction was prepared from the livers of male Sprague-Dawley rats treated with Aroclor 1254. The animals weighed approx. 200g and receveid a single injection of 500 mg/kg bw Aroclor 1254 five days prior to sacrifice.
- quality controls of S9 (e.g., enzymatic activity, sterility, metabolic capability): Prior to use, all batches of S9 mix were checked for suitability using 2-aminoanthracene as recognised mutagenic compound.

Test concentrations with justification for top dose:

Preliminary Toxicity Test:
without metabolic activation: 0, 1.5, 5, 15, 50, 150 and 500 µg/plate
with metabolic activation: 0, 5, 15, 50, 150, 500, 1500 and 5000 µg/plate

Main test: Experiments 1 + 2:
without metabolic activation: 0, 1.5, 5, 15, 50, 150 and 500 µg/plate
with metabolic activation: 0, 5, 15, 50, 150, 500, 1500 and 5000 µg/plate

Vehicle / solvent:

DMSO

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

no

Positive controls:

yes

Positive control substance:

4-nitroquinoline-N-oxide

9-aminoacridine

N-ethyl-N-nitro-N-nitrosoguanidine

other: 4-Nitro-o-phenylenediamine (4NOPD), -S9 mix, 5 µg/plate for TA 1538, 2-aminoanthracene (2AA), +S9 mix, 1 µg/plate for TA 100, 2 µg/plate for TA 1535 and TA 1537; 0.5 µg/plate for TA 1538 and TA 98

Details on test system and experimental conditions:

METHOD OF APPLICATION: both experiments: in agar (plate incorporation)

DURATION
- Exposure duration: 48 hrs

NUMBER OF REPLICATIONS: Triplicate plating in two independent experiments

DETERMINATION OF CYTOTOXICITY
- Method: plates were assessed for numbers of revertant colonies and examined for effects on the growth of the bacterial background lawn.

Evaluation criteria:

The test item was considered positive if:
There is a dose related increase in the number of revertants or a biologically relevant increase for at least one test concentration.

The test item was considered negative if:
The numner of induced revertants when compared to the solvent control (spontaneous revertants) is less than 2-fold at each dose level employed.

Statistics:

All data were statistically analysed acording to Kirkland (1989) and by using Dunnett's method of linear regression.

Kirkland D j (Ed) (1989) Statistical Evaluation of Mutagenicity Test Data, UKEMS Subcommittee on Guidelines for Mutagenicity Testing. Report - Part III - Cambridge University Press.

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at ≥150 µg/plate in all strains with and without S9 mix, in both experiments

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

True negative controls validity:

not examined

Positive controls validity:

valid

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at ≥150 µg/plate in all strains with and without S9 mix, in both experiments

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

True negative controls validity:

not examined

Positive controls validity:

valid

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at ≥150 µg/plate in all strains with and without S9 mix, in both experiments

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

True negative controls validity:

not examined

Positive controls validity:

valid

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at ≥150 µg/plate in all strains with and without S9 mix, in both experiments

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

True negative controls validity:

not examined

Positive controls validity:

valid

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at ≥150 µg/plate in all strains with and without S9 mix, in both experiments

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

True negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

RANGE-FINDING/SCREENING STUDIES:
A range-finding study in strain TA100 was performed using the plate-incorporation test and concentrations in the range of 15 - 5000 µg/plate with and without S9 mix. Toxicity was observed at ≥ 150 µg/plate without S9 mix and at ≥ 500 µg/plate with S9 mix.

STUDY RESULTS
There was no statistically significant increase in the number of revertant colonies observed for any strain in any experiment, neither with nor without metabolic activation.
The positive control chemicals induced marked increases in the frequency of revertant colonies, thus demonstrating the sensitivity of the test and the functionality of the S9 mix.

HISTORICAL CONTROL DATA: not provided in the study report.

Number of Revertants (Number of Colonies per plate)
Base-pair Substitution Type		Frameshift Type
TA100	TA1535	TA1538	TA98	TA1537
147	33	29	29	9
124    (133)	32    (34)	21  (25)	40   (31)	7   (10)
129	36	24	33	13
			2225 (22)b19
Number of Revertants (Number of Colonies per plate)
Base-pair Substitution Type		Frameshift Type
TA100	TA1535	TA1538	TA98	TA1537
88	15	9	23	7
93    (88)	19    (16)	7   (9)	22   (22)	8   (9)
84	15	10	21	12

Conclusions:

Interpretation of results: Negative in S. typhimurium strains TA98, TA100, TA1535, TA1537 and TA1538 with and without metabolic activation.

Executive summary:

Salmonella typhimurium strains TA1535, TA1537, TA1538, TA98 and TA100 were treated with the test material using the Ames plate incorporation method in triplicates, both with and without the addition of a rat liver homogenate metabolising system (10% liver S9 in standard co-factors). The dose range was determined in a preliminary toxicity assay and ranged between 1.5 and 5000 µg/plate in the first experiment. The vehicle (dimethyl sulphoxide) control plates produced counts of revertant colonies within the normal range. All the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies, both with and without the metabolising system. The test material caused a visible reduction in the growth of the bacterial lawn to all of the strains of salmonella tested. The sensitivity of the bacterial strains to the toxicity of the test material varied between strains and between exposures with or without S9 -mix. The first incidence of toxicity was recorded at 150µg/plate. The test material was, therefore, tested up to its toxic limit. The test material was considered to be NON-MUTAGENIC under the conditions of this test.

Reference 2

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

05 - 13 Aug 1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

adopted in 2020

Deviations:

yes

Remarks:

test conducted in 4 valid strains only; only a single experiment was reported; duplicate plating in 2 experiments; 2-aminoanthracene used as sole positive control for tests with S9 mix, no historical positive control data provided

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Target gene:

His-operon

Species / strain / cell type:

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

Additional strain / cell type characteristics:

not applicable

Species / strain / cell type:

S. typhimurium TA 1538

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

Type and composition of metabolic activation system: Cofactor supplemented post-mitochondrial fraction (S9 mix).
- method of preparation of S9 mix: S9 fraction was prepared from the livers of male Wistar rats. The animals receveid a single injection of 500 mg/kg bw Aroclor 1254 in oilve oil five days prior to sacrifice.

Test concentrations with justification for top dose:

Experiments 1 and 2: 4, 20, 100, 500 and 2500 µg/plate

Justification for top concentration: Dose levels were based on solubility in the solvent.

Vehicle / solvent:

Vehicle/solvent used: Acetone (first experiment, not reported) and DMSO (second experiment)

Untreated negative controls:

yes

Remarks:

untreated cells

Negative solvent / vehicle controls:

yes

Remarks:

DMSO, water

True negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

monomeric acrylamide

other: 2-aminoanthracene, +S9 mix, 5 µg/plate for all strains; 4-nitro-o-phenylendiamine, -S9 mix, 40µg/plate for strains TA98, TA1537 and TA1538

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION:
- Exposure duration: 48 hrs

NUMBER OF REPLICATIONS: Duplicate plating in 2 independent experiments. Controls were tested in triplicates.

DETERMINATION OF CYTOTOXICITY
- Method: plates were assessed for numbers of revertant colonies and examined for effects on the growth of the bacterial background lawn.

Evaluation criteria:

The test item was considered positive for gene mutation in bacteria if the following criteria were met:
- The plate background of non-revertant bacteria did not show any growth reduction versus the respective negative controls.
- The spontaneous mutation rates of each tester strain per plate were within the characteristic spontaneous mutation range.

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 100 µg/plate and above

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

True negative controls validity:

not examined

Positive controls validity:

valid

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 100 µg/plate and above

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

True negative controls validity:

not examined

Positive controls validity:

valid

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 100 µg/plate and above

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

True negative controls validity:

not examined

Positive controls validity:

valid

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 100 µg/plate and above

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

True negative controls validity:

not examined

Positive controls validity:

valid

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 100 µg/plate and above

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

True negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Other confounding effects: The first experiment was performed using acetone as solvent and concentrations of 4 - 2500 µg/plate. All plates showed inhibition of bacterial growth, therefore the test was repeated using DMSO as solvent.

STUDY RESULTS :
There was no statistically significant increase in the number of revertant colonies induced by the test item observed at any concentration in any experiment, neither with nor without S9 mix.

HISTORICAL CONTROL DATA
- Positive historical control data: not provided
- Negative (solvent/vehicle) historical control data: mean values (range)
without S9 mix:
TA1535: 6 (1-25)
TA100: 87 (35-201)
TA1537: 7 (1-24)
TA1538: 15 (6-27)
TA98: 20 (5-39)

with S9 mix:
TA1535: 8 (1-25)
TA100: 105 (54-252)
TA1537: 6 (1-23)
TA1538: 18 (3-48)
TA98: 27 (7-76)

Detailed information are provided under 'Attached background material'.

Conclusions:

Interpretation of results: Negative in S. typhimurium strains TA98, TA100, TA1535, TA1537 and TA1538 with and without metabolic activation.

Reference 3

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

weight of evidence

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.

Reference 4

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, 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.

Reference 5

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

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 adverse effect observed (negative)

Additional information

In vitro gene mutation in mammalian cells

Data on in vitro gene mutation in bacteria are available for alcohols, C12-14, ethoxylated (CAS No. 68439-50-9, EC No. 500-213-3) as well as several member substances of the Alcohol Ethoxylates (AE) category.

 

Studies with alcohols, C12-14, ethoxylated (CAS No. 68439-50-9, EC No. 500-213-3)

S. typhimurium strains TA 1535, TA 1537, TA 1538, TA 98 and TA 100 were treated with alcohols, C12-14, ethoxylated (CAS No. 68439-50-9, EC No. 500-213-3) using the Ames plate incorporation method at six dose levels for each bacterial strain, in triplicate, both with and without the addition of a rat liver homogenate metabolising system (10% liver S9 in standard co-factors). The study was conducted according to OECD guideline 471 under GLP conditions (Kao, 1996c). The dose range was determined in a preliminary toxicity assay and ranged between 1.5 and 5000 µg/plate in the first experiment. The experiment was repeated on a separate day using the same dose range as in experiment 1, fresh cultures of the bacterial strains and fresh test material formulations. Extra dose levels were included in each experiment to allow for the toxicity of the test material. The vehicle (dimethyl sulphoxide, DMSO) control plates produced counts of revertant colonies within the normal range. All of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies, both with and without the metabolising system. The test material caused a visible reduction in the growth of the bacterial lawn to all of the strains of Salmonella tested. The first incidence of toxicity was recorded at 150 µg/plate. The test material was, therefore, tested up to its toxic limit. No significant increase in the frequency of revertant colonies was recorded for any of the bacterial strains with any dose of the test material, either with or without metabolic activation. The test material was considered to be non-mutagenic under the conditions of this test.

The result of the first Ames test is supported by a further investigation of the potential to induce gene mutation in bacteria performed similar to OECD guideline 471 (BASF, 1994). The assay was conducted with the S. typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and TA 1538 in one experiment, with and without metabolic activation by S9 mix. Two parallel plates per tested concentration were used; for the positive controls, threee plates were used. Solutions of the test substance were prepared in DMSO. The following concentrations were tested: 4, 20, 100, 500 and 2500 µg/plate. The following results were obtained: Toxic effects were noted at concentrations of approx. 100 µg/plate onwards. No enhanced revertant rates compared to concurrent negative controls were observed in all tested strains, neither in the presence nor the absence of metabolic activation. The test substance did not induce reverse mutations in the tested strains of S. typhimurium and is, therefore, considered not mutagenic.

 

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 alcohols, C12-14, ethoxylated (CAS No. 68439-50-9, EC No. 500-213-3). 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 alcohols, C12-14, ethoxylated (CAS No. 68439-50-9, EC No. 500-213-3). 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 alcohols, C12-14, ethoxylated (CAS No. 68439-50-9, EC No. 500-213-3) 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.