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EC number: 500-343-0 | CAS number: 157627-92-4 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
The assessment is based on the data currently available. New studies, based on the category review and the final decisions issued for some of the category substances, which are also relevant for this assessment, are currently being conducted. The hazard assessment with respect to genetic toxicity will be updated once all ongoing studies have been finalised.
In vitro gene mutation in bacteria has been tested using the target substance.
Bacterial reverse mutation assay (Ames / OECD 471): negative
No data on genotoxicity in mammalian cells are available for the target substance Alcohols, C10-16, ethoxylated (1-2.5 EO), sulfates, monoeth. salts (CAS 157627-92-4). Therefore, read-across from structural analogue substances has been applied.
In vitro mammalian cell gene mutation assay (MLA / OECD 476):
negative
Read-across from structural analogue source substance Alcohols, C12-14, ethoxylated, sulfates, sodium salts (CAS 68891-38-3).
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- No E.coli strains tested (nor the TA102 strain)
- GLP compliance:
- not specified
- 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:
- S9
- Test concentrations with justification for top dose:
- 0, 10, 100, 1000, 10000, 100000 µg/plate
- Vehicle / solvent:
- distilled water
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
- Evaluation criteria:
- According to Guideline.
- Statistics:
- yes
- 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:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- 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:
- not examined
- True negative controls validity:
- not examined
- 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:
- not examined
- True negative controls validity:
- not examined
- 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:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Conclusions:
- In the present in vitro bacterial reverse mutation assay (Ames test), the test substance did not show any genotoxic potential in presence or absence of metabolic activation (S9-Mix) when tested in the bacterial strains TA1535, TA1537, TA98, TA100 or TA1538.
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- mammalian cell gene mutation assay
- Target gene:
- TK operon
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- -S9: 2.44, 4.88, 9.76, 19.5, 39.1, 58.6 µg/mL
+S9: 2.44, 4.88, 9.76, 19.5, 39.1, 78.1, 117 µg/mL - Vehicle / solvent:
- n.a.
- Untreated negative controls:
- yes
- Remarks:
- untreated cells
- Negative solvent / vehicle controls:
- no
- Remarks:
- no vehicle used
- Positive controls:
- yes
- Positive control substance:
- other: ethylmethanesulphonate, 7,12-dimethylbenzanthracene
- Evaluation criteria:
- According to Guideline.
- Statistics:
- yes
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- Interpretation of results: negative
Referenceopen allclose all
Table 1: Results of the Plate-Incorporation Test
Without S9-Mix | Test substance concentration (µg/plate) | Mean number of revertant colonies per plate (average of 3 plate ± SD) | ||||
Base-pair substitution type | Frameshift type | |||||
TA 100 | TA 1535 | TA 1538 | TA 98 | TA 1537 | ||
0 | 222 ± 20 | 12 ± 3 | 12 ± 2 | 10 ± 3 | 11 ± 2 | |
10 | 187 ± 31 | 13 ± 1 | 18 ± 3 | 11 ± 1 | 5 ± 2 | |
10^2 | 231 ± 8 | 9 ± 2 | 12 ± 1 | 13 ± 4 | 6 ± 0 | |
10^3 | 102 ± 13 | 18 ± 4 | 32 ± 1 | 16 ± 4 | 7± 3 | |
10^4 | / | / | / | / | / | |
10^5 | / | / | / | / | / | |
Positive controls (-S9) | Name | Na azide | Na azide | 2-NF | 2-NF | 9-AA |
Concentration (µg/plate) | 5 | 5 | 10 | 10 | 40 | |
Mean No. of colonies/plate (average of ± SD) | / | / | 50 ± 4 | 47 ± 1 | 37 ± 2 | |
With S9-Mix | 0 | 155 ± 15 | 8 ± 2 | 15 ± 5 | 15 ± 2 | 12 ± 1 |
10 | 199 ± 46 | 12 ± 3 | 8 ± 3 | 14 ± 4 | 9 ± 1 | |
10^2 | 177 ± 7 | 9 ± 3 | 11 ± 4 | 13 ± 2 | 9 ± 3 | |
10^3 | 151 ± 14 | 10 ± 1 | 7 ± 4 | 12 ± 3 | 11 ± 2 | |
10^4 | 135 ± 7 | / | / | / | / | |
10^5 | 123 ± 4 | / | / | / | / | |
Name | 2AA | 2AA | 2AA | 2AA | 2AA | |
Concentration (µg/plate) | 1 | 1 | 1 | 1 | 1 | |
Mean No. of colonies/plate (average of ± SD) | / | 81 ± 9 | / | / | 88 ± 18 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
No data on in vivo genotoxicity are available for the target substance Alcohols, C10-16, ethoxylated (1-2.5 EO), sulfates, monoeth. salts (CAS 157627-92-4). Therefore, read-across from structural analogue substances has been applied.
Mammalian Bone Marrow Chromosome Aberration Test (CA / OECD 475): negative
Read-across from structural analogue source substance Alcohols, C12-14, ethoxylated, sulfates, sodium salts (CAS 68891-38-3).
Link to relevant study records
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- chromosome aberration assay
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- According to Guideline.
- Route of administration:
- oral: gavage
- Vehicle:
- Distilled water
- Duration of treatment / exposure:
- n.a.
- Frequency of treatment:
- Once
- Post exposure period:
- test group: 10, 24 and 48 h
positive control: 26 h - Remarks:
- Doses / Concentrations:
0, 1000, 2000 mg/kg bw
Basis:
nominal conc. - No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide (50 mg/kg bw)
- Tissues and cell types examined:
- Femoral bone marrow cells
- Details of tissue and slide preparation:
- SAMPLING TIMES
test groups: 10, 24 and 48 h after treatment
positive control group: 26 h after treatment - Evaluation criteria:
- According to Guideline.
- Statistics:
- Yes
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Conclusions:
- Interpretation of results: negative
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
The assessment is based on the data currently available. New studies, based on the category review and the final decisions issued for some of the category substances, which are also relevant for this assessment, are currently being conducted. The hazard assessment with respect to genetic toxicity will be updated once all ongoing studies have been finalised.
Only data regarding mutation in bacteria have been obtained using the target substance. No data are available for other genotoxicity endpoints, i.e. mutation in mammalian cells and clastogenicity. Therefore, the latter endpoints are covered by read-across from structurally related AES. The AES reported within the category show similar structural, physico-chemical, environmental and toxicological properties. The approach of grouping different AES for the evaluation of their effects on human health and the environment was also made by the Danish EPA (2001) and HERA (2003), supporting the read-across approach between structurally related AES.
Genetic toxicity
There is one key study available addressing genetic toxicity for AES (C12-14; < 2.5 EO) C2H7NO (CAS No. 157627-92-4). Mutagenicity in bacteria is assessed in this key study performed similar to OECD Guideline 471 using Salmonelly typhimurium strains TA 1535, TA 1537, TA 1538, TA 98 and TA 100; the tester strain E.coli was not considered in this study (Z&S, 1996). The tester strains were treated using the plate incorporation method with and without the addition of a rat liver S9-mix. The dose range for the plate incorporation test was 0, 10, 100, 1000, 10000 and 100000 µg/plate. Results achieved with vehicle (distilled water) and positive controls were valid. Cytotoxicity was seen in presence and absence of metabolic activation while no genotoxicity was observed under both circumstances for AES (C12-14; < 2.5 EO) monoeth salt (CAS No. 157627-92-4).
There are two additional studies available addressing in vitro genotoxicity for the analogue substance AES (C12-14; 1-2.5EO) Na (CAS 68891-38-3).
Mutagenicity in bacteria was assessed in a key study performed similar to OECD Guideline 471. Tester strain TA 102 or E.coli were not used during the conduct of the study (Sasol, 1994). In this study, Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 1538 and TA 100 were treated using the plate incorporation method with and without the addition of a rat liver S9-mix. The dose range for the plate incorporation test was 11, 56, 280, 1400 and 7000 µg/plate. Results achieved with vehicle (distilled water) and positive controls were valid. Cytotoxicity was seen in the presence and absence of metabolic activation while no genotoxicity was observed under both circumstances for AES (C12-14; 1-2.5 EO) Na (CAS 68891-38-3).
The mutagenicity of AES (C12-14) Na (CAS 68891-38-3, analytical purity 27.6% a.i., no data on grade of ethoxylation) in a mammalian cell line was investigated according to OECD guideline 476 using the mouse lymphoma L5178Y cells with and without metabolic activation (BASF, 1995a). The test concentrations were 2.44, 4.88, 9.76, 19.5, 39.1 and 58.6 µg/mL without metabolic activation as well as 2.44, 4.88, 9.76, 19.5, 39.1, 78.1 and 117 µg/mL with metabolic activation. Results achieved with the negative (distilled water) and positive controls were valid. Cytotoxicity was seen in presence and absence of metabolic activation while no genotoxicity was observed under both circumstances for Na AES (C12-14, 1-2.5 EO) (CAS 68891-38-3).
Referring to in vivo genotoxicity, the in vivo clastogenic potential of the analogue compound AES(C12-14) Na (CAS 68891-38-3, analytical purity 27-29% a.i., no data on grade of ethoxylation) was assessed in a mammalian bone marrow chromosomal aberration test with CD-1 mouse according to OECD Guideline 475 (BASF, 1995b). The test substance was administered via gavage at doses of 1000 and 2000 mg/kg bw to five animals per sex per dose. Distilled water was used as vehicle. The post exposure period were 10, 24 and 48 h for the test group including the vehicle control and 26 h for the positive control group. Results achieved with the negative (distilled water) and positive controls were valid. No signs of toxicity and no increased number of chromosome aberration were seen at 1000 and 2000 mg/kg bw. Thus the test substance did not show clastogenicity at 1000 and 2000 mg/kg bw based on the test material and 270 to 290 and 540 to 580 mg/kg bw based on the active ingredient.
In conclusion, the test substance did not show any genotoxic potential. This is supported by the conclusions of the HERA (2003) report for AES were it is stated that: “In all available in vitro and in vivo genotoxicity assays, there is no indication of genetic toxicity of AES.”
Influence of counter ions on genotoxicity
Since monoethanolamine (MEA) in its protonated form (monoethanolammonium) is the counter-ion present in Alcohols C10-16, ethoxylated (1-2,5 EO) sulphated, monoeth salts (CAS 157627-92-4), MEA might have an impact on the toxicological properties of the registered substance. Therefore, the toxicological profile of MEA is considered. MEA is listed in Annex VI of Regulation 1272/2008. It is classified as Acute Tox. 4; H302, H312 and H332 as well as Skin Corr. 1B; H314. Additionally a specific concentration limit is established for STOT SE3, H335 at concentrations ≥ 5% in Annex VI of Regulation 1272/2008.The effects of MEA on human health were assessed by the OECD in the SIDS initial assessment Report (2013). MEA was found to be not genotoxic in vitro and in vivo. Thus, MEA will not confer adverse effects regarding this endpoint.
References:
Danish EPA - Environmental and Health Assessment of Substances in Household Detergents and Cosmetic Detergent Products (2001). Environmental Project No. 615, pp. 24-28
HERA (2003). Human & Environmental Risk Assessment on ingredients of European household cleaning products Alcohol Ethoxysulphates, Human Health Risk Assessment Draft, 2003. http: //www. heraproject. com.
SIDS initial assessment report, (2013);
http://webnet.oecd.org/HPV/UI/SIDS_Details.aspx?key=8aefe41b-8499-4052-943f-f6dd6f8c5997&idx=0
Justification for classification or non-classification
The available data on genetic toxicity do not meet the criteria for classification according to Regulation (EC) No. 1272/2008 (CLP) and are therefore conclusive but not sufficient for classification.
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