Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Bacterial reverse mutation assay (Ames / OECD 471): negative

Read-across from structural analogue source substance Alcohols, C16-18, ethoxylated (CAS 68439-49-6).

In vitro mammalian chromosomal aberration assay (ChrAb / OECD 473): negative

Read-across from structural analogue source substance Alcohols, C16-18, ethoxylated (CAS 68439-49-6).

In vitro mammalian cell gene mutation assay (MLA / OECD 476): negative

Read-across from structural analogue source substance Alcohols, C16-18, ethoxylated (CAS 68439-49-6).

Link to relevant study records

Referenceopen allclose all

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Refer to the analogue justification provided in IUCLID6 section 13
Reason / purpose:
read-across source
Key result
Species / strain:
other: TA 1535, TA 1537, TA 98 and 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
Remarks on result:
other: Source, key, 68439-49-6, 1997
Conclusions:
interpretation of results: negative
Executive summary:

The potential of gene mutations in bacteria of the target substance is estimated based on an adequate and reliable in vitro gene mutation study in bacteria from the structural analogue source substance Alcohols, C16-18, ethoxylated (CAS 68439-49-6). Experiments have been performed both in the presence as well as in the absence of metabolic activation. All results obtained were negative, i.e. no gene mutation in bacteria was observed. Therefore, based on read-across, the target substance is not expected to be mutagenic in bacteria. As explained in the category justification, the differences in molecular structure between the target and the source substances are unlikely to lead to differences in gene mutation in bacteria.

Endpoint:
in vitro cytogenicity / chromosome aberration study in mammalian cells
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Refer to the analogue justification provided in IUCLID6 section 13
Reason / purpose:
read-across source
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
Remarks on result:
other: Source, key, 68439-49-6, 1995b
Conclusions:
interpretation of results: negative
Executive summary:

The potential of chromosome aberrations in mammalian cells of the target substance is estimated based on an adequate and reliable in vitro study from the structural analogue source substance Alcohols, C16-18, ethoxylated (CAS 68439-49-6). Experiments have been performed both in the presence as well as in the absence of metabolic activation in chinese hamster ovary cells. All results obtained were negative, i.e. no chromosome aberrations were observed in mammalian cells. Therefore, based on read-across, the target substance is not expected to be clastogenic in mammalian cells. As explained in the category justification, the differences in molecular structure between the target and the source substances are unlikely to lead to differences in the potential to form chromosome aberrations.

.

Endpoint:
in vitro gene mutation study in mammalian cells
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Refer to the analogue justification provided in IUCLID6 section 13
Reason / purpose:
read-across source
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
Remarks on result:
other: Source, key, 68439-49-6, 1995c
Conclusions:
Interpretation of results: negative
Executive summary:

The potential of gene mutation in mammalian cells of the target substance is estimated based on an adequate and reliable in vitro study from the structural analogue source substance Alcohols, C16-18, ethoxylated (CAS 68439-49-6). Experiments have been performed both in the presence as well as in the absence of metabolic activation in chinese hamster ovary cells. Mutations in the HPRT locus were investigated. All results obtained were negative, i.e. no gene mutations were observed in mammalian cells. Therefore, based on read-across, the target substance is not expected to be mutagenic in mammalian cells. As explained in the category justification, the differences in molecular structure between the target and the source substances are unlikely to lead to differences in the potential of gene mutations in mammalian cells.

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

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No data regarding mutagenicity in bacteria are available for C16AE (CAS 9004-95-9). Therefore, mutagenicity in bacteria was addressed using reliable data as available from the structurally-related substance

C16-18AE (CAS 68439-49-6) for read-across. The study (Sasol, 1997) was conducted according to OECD Guideline 471. Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 were treated with C16-18AE (CAS 68439-49-6) using the plate incorporation method as well as the preincubation method, both with and without the addition of a rat liver S9-mix. The dose ranges were for the plate incorporation test were 50, 160, 500, 1600 and 5000 µg/plate; for the first preincubation test 50, 150, 300, 900 and 1500 µg/plate and for the second one 10, 25, 50, 100 and 150 µg/plate. All tests were done in triplicates. The vehicle (acetone) and negative (untreated) control plates produced counts of revertant colonies within an acceptable range. All positive controls used in the test induced marked increases in the frequency of revertant colonies, both with and without the metabolising system. A reproducible mutagenic activity of the test material to any of the tester strains was not observed with and without metabolic metabolic activation. Thus, under the conditions of this test the test substance can be regarded as not mutagenic in bacteria.

 

No data regarding the clastogenic potential are available for C16AE (CAS 9004-95-9). Therefore, the clastogenic potential was addressed using reliable data as available from the structurally-related substance

C16-18AE (CAS 68439-49-6) for read-across. The study (Sasol, 1995b) was conducted in mammalian cells according to OECD Guideline 473. Chinese hamster ovary cells (CHO) were exposed to 313, 625, 1250, 2500 and 5000 µg/mL in the presence and 1.25, 2.5, 5, 10, 20, 39 and 78 µg/mL in the absence of metabolic activation. Positive and vehicle (1% ethanol) control cultures were included in each assay. No increases in the number of chromosome aberrations in the presence or absence of metabolic activation were seen at any concentration tested. Appropriate reference mutagens used as positive controls showed a significant increase in chromosome aberrations, thus confirming the sensitivity of the assay, and the efficacy of the S9-mix. Hence, the test substance can not be regarded as clastogenic.

 

No data regarding the mutagenic potential in mammalian cells are available for C16AE (CAS 9004-95-9). Therefore, the mutagenic potential in mammalian cells was addressed using reliable data as available from the structurally-related substance C16-18AE (CAS 68439-49-6) for read-across. The study (Sasol, 1995c) was conducted according to OECD Guideline 476 (HPRT-assay). Following pre-tests with the concentration ranging from 1-100 µg/mL, the latter being the solubility limit of the test substance, Chinese hamster ovary cells were exposed for 4 h to concentrations of 1.8, 6, 18, 60 and 100 µg/mL in the absence and presence of metabolic activation by rat liver S9-mix. No dose-related increases in mutant colony numbers were obtained in two independent experiments with the test substance in either the presence or absence of S9-mix. Appropriate reference mutagens used as positive controls produced highly significant increases in mutation frequency, thus confirming the sensitivity of the assay. Therefore, the test substance is regarded as not mutagenic in mammalian cells.

 

In conclusion, C16AE (CAS 9004-95-9) is regarded as non-genotoxic.

Justification for classification or non-classification

According to the classification criteria of Regulation (EC) No. 1272/2008 (CLP), the substance does not need to be classified for genotoxicity.