Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 500-014-1 | CAS number: 9004-95-9 1 - 2.5 moles ethoxylated
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Endpoint summary
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
- 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:
- S. typhimurium, 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.
Referenceopen allclose all
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.

Route: .live2