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EC number: 500-002-6 | CAS number: 9002-92-0 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
Ames assay
In an Ames test , test chemical dissolved in dimethyl sulfoxide from doses 0 - 1000 micrograms per plate was not mutagenic in Salmonella typhimurium strain TA 100, TA1535, TA1537 and TA98 with and without addition of S9 liver fractions from Aroclor induced hamsters and rats.
In vitro chromosomal abbreviation study
In an Chromosomal aberration test ,test chemical dissolved in water from doses 0, 5,15 and 50 micrograms per plate was not mutagenic in Chinese Hampster Ovary (CHO) LB cells with and without addition of S9 liver fractions from Aroclor induced rats.
In vitro Mammalian cell gene mutation assay
Test chemical was evaluated for its mutagenic potential in mouse lymphoma by in vitro mammalian cell gene mutation. The test result was considered to be negative in Mouse lymphoma.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data from handbook or collection of data
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- Preincubation Assay
The preincubation assay was performed . The test chemical, Salmonella culture, and S-9 mix or buffer were incubated at 37"C, without shaking, for 20 min. Chemicals known or suspected to be volatile were incubated in capped tubes. The top agar was added, and the contents of the tubes were mixed and poured onto the surface of petri dishes that contained Vogel-Bonner medium [Vogel and Bonner, 19561. The histidine-revertant (his') colonies arising on these plates were counted following 2 days incubation at 37°C. The plates were hand-counted when a precipitate was present; otherwise automatic colony counters were used.
All chemicals were tested initially in a toxicity assay to determine the appropriate dose range. The toxicity assay was performed by using TA100 or the system.
Toxic concentrations were those at which a decrease in the number of hisf colonies was seen or at which there was a clearing in the density of the background lawn.At least five doses of the chemical were tested in triplicate. Experiments were repeated at least 1 wk following the initial trial. Each chemical was tested initially at half-log doses up to a dose that elicited toxicity; subsequent trials occasionally used narrower dose increments. Chemicals that were not toxic were tested to a maximum dose of 10 mglplate. Chemicals that were poorly soluble were tested up to a dose defined by their solubility. A maximum of 0.05 ml solvent was added to each plate.Concurrent solvent and positive controls were run with each trial. The positive controls in the absence of metabolic activation were sodium azide (TA1535 and TA loo), 9-aminoacridine (TA97 and TA 1S37), and 4-nitro-o-phenylenediamine (TA98). The positive control for metabolic activation was 2-aminoanthracene for all strains. Although there were no specific response ranges established for the solvent and positive controls, each laboratory rejected experiments in which the positive control chemical did not produce a mutagenic response or in which the solvent controlvalues were higher (or lower in the case of TAlOO and TA97) than their expected values.During the initial stages of the testing program, chemicals were tested with 10% S-9. Other levels of S-9 were used when an equivocal result was obtained with 10%. The protocol evolved to one that used 30% S-9 when a negative response was obtained with 10% S-9. - GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- histidine-manufacturing gene.
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: All the bacterial strains used in the Ames test carry a defective (mutant) gene that prevents them from synthesizing the essential amino acid histidine from the ingredients in standard bacterial culture medium.
- Metabolic activation:
- with and without
- Metabolic activation system:
- 10% HLI =induced male Syrian hamster liver S9 ; 10% RLI = induced male Sprague Dawley rat liver S9
- Test concentrations with justification for top dose:
- 0,1,3,10,33,100,333 and 1000 µg/Plate
- Vehicle / solvent:
- Vehicle Control : Dimethyl Sulfoxide
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- Positive control for TA 100 and TA 1535 tested in the absence of S9 Migrated to IUCLID6: without S9
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Water
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- Positive control for TA 98 tested in the absence of S9
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Water
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- Positive control for TA 1537 tested in the absence of S9
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Water
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene (or occasionally, sterigmatocystin)
- Remarks:
- For all strains(TA 100,TA 1535, TA1537, TA98) tested with S9
- Details on test system and experimental conditions:
- All chemicals were tested in Salmonella typhimurium strains TA98, TA100,TA1535, and TA1537 and/or TA97. The majority of chemicals were tested in TA1537,and a few were tested in TA97. The testing in both strains is the result of an evolution of the protocol described by Haworth et a1 [1983]. In this original protocol, TA1537 was used. In a later protocol, TA97 replaced TA1537, but the option to retest a chemical in TA1537 was retained for chemicals that produced a positive or questionable response in TA97 and negative responses in the other strains.All strains were obtained from Dr. Bruce Ames and were stored as recommended [Maron and Ames, 19831. Prior to their use for mutagenicity assays, all cultures were grown overnight with shaking at 37°C in Oxoid broth, and their phenotypes were analyzed.
- Evaluation criteria:
- The histidine-revertant (his') colonies were observed for mutagenicity.
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- with 10% HLI and 10% RLI
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- with 10% HLI and 10% RLI
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- with 10% HLI and 10% RLI
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- with 10% HLI and 10% RLI
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- In an Ames test , test chemical dissolved in dimethyl sulfoxide from doses 0 - 1000 micrograms per plate was not mutagenic in Salmonella typhimurium strain TA 100, TA1535, TA1537 and TA98 with and without addition of S9 liver fractions from Aroclor induced hamsters and rats.
- Executive summary:
Genetic toxicity in vitro study was assessed for test chemical. For this purpose AMES test was performed .The test material was exposed to Salmonella typhimurium TA100, TA1535, TA98 and TA1537in the presence and absence of metabolic activation S9. The concentration of test material used in the presence and absence of metabolic activation were 0 ,1,3,10,33,100,333and 1000 µg/plate. No mutagenic effects were observed in all strains, in the presence and absence of metabolic activation. Therefore test chemical was considered to be non-mutagenic in Salmonella typhimurium TA100, TA1535, TA98 and TA1537by AMES test. Hence the substance cannot be classified as gene mutant in vitro.
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data from handbook or collection of data
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- Approximately 24 hr before chemical treatment. cultures were initiated at a density of 1.75 X 10‘ cells/75 cm’ flask.In the AB trials without S9, the cultures were treated with the test chemical in medium for 8 hr, washed to remove the test chemical, and treated with colcemid M) for 2-2.5 hr before cell harvest. In the experiments with activation,cultures were exposed to the test chemical in serumfree medium with S9 and cofactors for 2 hr, washed to remove the test chemical and S9, and incubated at 37°C with fresh medium for 8 hr. Colcemid was then added, and the cells were harvested 2 hr later. Thus the total durations of the nonactivated and activated AB experiments were 10 hr and 12 hr, respectively, to give 10 hr growth in medium
with serum for each experiment. This differs from the protocol previously used when the total length of each AB trial was 10 hr (Galloway et al., 19871. Where cell cycle delay was noted in the corresponding SCE experiment, the cell growth period in the AB trial was extended approximately 6-8 hr. In the extended trials without S9, the chemical was present for the additional time. Colcemid was present only for the final 2--3 hr. - GLP compliance:
- not specified
- Type of assay:
- in vitro mammalian chromosome aberration test
- Target gene:
- Not specified
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- RAT, LIVER, S-9, AROCLOR 1254
- Test concentrations with justification for top dose:
- Dose : 0, 5,15 and 50 µg/mL
At least five concentrations of the test chemical were selected; the concentrations were spaced using two merged half-log scales (e.g., 1,000, 500, 300, 150, 100, etc.), and the highest concentrations analyzed were those yielding a sufficient number of suitable metaphase cells. The concentrations analyzed generally covered a one-log range. - Vehicle / solvent:
- water
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- mitomycin C (Positive control for Without metabolic activation, Dose= 1 and 5 µg/ml)
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- cyclophosphamide (Positive control for With metabolic activation , Dose = 50 µg/ml
- Details on test system and experimental conditions:
- Controls:-
Medium and solvent controls were used with each assay.Solvent controls consisted of culture medium with or without S9 and contained the same concentration of solvent as the test cultures (0.5 or 1%).Mitomycin C (MMC; Sigma) was used in the experiments withoul metabolic activation, and cyclophosphaniide (CP; Sigma) was used in the experiments with activation as positive controls. Stock solutions of these chemicals were stored at 4°C and used for three months without loss of activity.Two MMC concentrations were used for the positive controls in the SCE assays, a low MMC concentration that was known to induce a 20-80% increase in SCEs and a high concentration that was used to give greater than a 100% increase in SCEs. The low-dose positive control was used to provide an indication of the ability of the individual experiment to detect a low-level, chemically induced response [Margolin and Resnick, 19851. A negative test chemical response was considered valid only if the low-dose positive control exceeded the solvent control by 20’70. Low and high positive control concentrations were as follows: experiments with S9 used CP at 0.4-0.5 and 2.5 pgiml, experiments
without S9 used MMC at 0.0015-0.002 and 0.010 pgiml .In the AB assays, a single CP dose of 50 pgiml was used in the test with S9, and an MMC dose of 5 pg/ml was used in the test without S9; these doses induced aberrations in approximately 50% of the cells. In some of the experiments,
a lower concentration of MMC, 0. I pgiml, was also used. - Evaluation criteria:
- Staining and Scoring of Slides :
For ABs, slides were stained in 5% Giemsa for 5 min. In early studies, one hundred cells were scored for each of three concentrations: the highest test concentration in which sufficient metaphase cells could be scored and the next two lower concentrations, covering a one-log range. For later studies, 200 cells per dose were scored; however, fewer cells were scored if a test chemical produced a strong positive response or the chemical was toxic.
Cells were analyzed for the following categories of chromosomal aberrations: “simple,” defined as a chromatid gap, break, fragment, and deletion or chromosome gap,break, or double minutes; “complex,” defined as interstitial deletions, triradials, quadriradials, rings, and dicentric chromosomes; and “other,” defined as pulverized chromosomes or cells with greater than 10 aberrations. Chromatid and chromosome gaps were recorded but were not used in the analysis. The frequency of polyploid or endoreduplicated cells was noted only when it seemed excessive; however, these categories were not included in the totals or in the statistical analyses. - Species / strain:
- Chinese hamster Ovary (CHO)
- 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
- Remarks on result:
- other: No mutagenic effects were observed
- Conclusions:
- In an Chromosomal aberration test ,test chemical dissolved in water from doses 0, 5,15 and 50 micrograms per plate was not mutagenic in Chinese Hampster Ovary (CHO) LB cells with and without addition of S9 liver fractions from Aroclor induced rats.
- Executive summary:
Genetic toxicity in vitro study was assessed for test chemical. For this purpose in vitro mammalian chromosome aberration test was performed .The test material was exposed to Chinese hamster ovary cells in the presence and absence of metabolic activation S9. The concentration of test material used in the presence and absence of metabolic activation were 0, 5, 15 and 50 µg/mL. Chromosome aberration, Chromosome gaps and breaks were not observed in the presence or absence of metabolic activation. Therefore test chemical was considered to be non - mutagenic in Chinese hamster ovary cells by in vitro mammalian chromosome aberration test. Hence the substance cannot be classified as mutagenic in vitro.
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data from handbook or collection of data
- Qualifier:
- according to guideline
- Guideline:
- other: As mention bvelow
- Principles of method if other than guideline:
- To evaluate the mutagenic potential of test chemical in mouse lymphoma by in vitro mammalian cell gene mutation.
- GLP compliance:
- not specified
- Type of assay:
- other: In vitro mammalian cell gene mutation.
- Target gene:
- Not specified
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- not specified
- Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- not specified
- Metabolic activation:
- not specified
- Test concentrations with justification for top dose:
- 0,5,19,15,20,30,30,40,50 µg/mL
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Dimethyl Sulfoxide
- Justification for choice of solvent/vehicle: The test substance is soluble in water - Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Water
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Water
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 3-methylcholanthrene
- Details on test system and experimental conditions:
- Details on test system and conditions
METHOD OF APPLICATION: In culture dish
DETERMINATION OF CYTOTOXICITY; relative total growth - Evaluation criteria:
- The mammalian cells were observed for mutagenic frequency in cells.
- Statistics:
- Yes, SD ± Mean was observed.
- Key result
- Species / strain:
- other: mouse lymphoma
- Metabolic activation:
- not specified
- 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
- Remarks on result:
- other: No mutaghenic effect were observed
- Conclusions:
- Test chemical was evaluated for its mutagenic potential in mouse lymphoma by in vitro mammalian cell gene mutation. The test result was considered to be negative in Mouse lymphoma.
- Executive summary:
Genetic toxicity in vitro study was assessed for test chemical. For this purpose in vitro mammalian cell gene mutation was performed .The test material was exposed to mouse lymphoma cells. The concentration of test material used in two experiment were 0,5,19,15,20,30,30,40,50 µg/mL. Mutagenic frequency were not observed in the mammalian cells. Therefore test chemical was considered to be non-mutagenic IN mouse lymphoma cells by in vitro mammalian cell gene mutation. Assay. Hence the substance cannot be classified as mutagenic in vitro.
Referenceopen allclose all
TA 100
Dose |
No Activation
(Negative) |
No Activation
(Weakly Positive) |
10% RLI
(Negative) |
10% RLI
(Negative) |
10% HLI
(Negative) |
10% HLI
(Negative) |
||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Protocol | Preincubation | Preincubation | Preincubation | Preincubation | Preincubation | Preincubation | ||||||
ug/Plate | Mean | ±SEM | Mean | ±SEM | Mean | ±SEM | Mean | ±SEM | Mean | ±SEM | Mean | ±SEM |
0 |
99 | 2 | 98 | 3.8 | 137 | 1.7 | 94 | 5.5 | 143 | 5.5 | 111 | 7 |
1 |
119 | 7 | ||||||||||
3 |
95 | 3.2 | 132 | 3.8 | 115 | 6.5 | 122 | 8.7 | ||||
10 |
98 | 6 | 137 | 5 | 164 | 7.4 | 107 | 3.7 | 139 | 9.7 | 123 | 11.8 |
33 |
97 | 8.6 | 120 | 8.8 | 151 | 8.2 | 127 | 1.8 | 135 | 4.6 | 120 | 5.2 |
100 |
61 | 5.3 | 105 | 4.6 | 157 | 3 | 111 | 8.1 | 146 | 7.7 | 116 | 11 |
333 |
0 | 0 | 139 | 8 | 60 | 6.2 | 136 | 19.7 | 85 | 12.5 | ||
1000 |
23 | 4.4 | 11 | 2.2 | ||||||||
Positive Control | 322 | 6 | 405 | 7.1 | 885 | 103.7 | 419 | 26.3 | 1065 | 143.4 | 1204 | 108.6 |
TA 1535
Dose |
No Activation
(Negative) |
No Activation
(Negative) |
10% RLI
(Negative) |
10% RLI
(Negative) |
10% HLI
(Negative) |
10% HLI
(Negative) |
||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Protocol | Preincubation | Preincubation | Preincubation | Preincubation | Preincubation | Preincubation | ||||||
ug/Plate | Mean | ±SEM | Mean | ±SEM | Mean | ±SEM | Mean | ±SEM | Mean | ±SEM | Mean | ±SEM |
0 |
25 | 3.8 | 20 | .9 | 11 | 1.5 | 7 | .9 | 6 | 1.3 | 7 | 2.3 |
1 |
29 | 1.5 | ||||||||||
3 |
29 | 1.5 | 26 | 4.2 | 7 | .6 | 10 | 1.5 | ||||
10 |
29 | 4 | 33 | 2.9 | 11 | 1.5 | 10 | 1.5 | 10 | 1.5 | 5 | 2 |
33 |
23 | 4.3 | 27 | 4.9 | 13 | .7 | 9 | 2.3 | 9 | 3.5 | 11 | 1.7 |
100 |
32 | 3.2 | 19 | 4.8 | 9 | 2.7 | 7 | 1.2 | 13 | .7 | 12 | 1.8 |
333 |
14 | .9 | 7 | .9 | 7 | .7 | 12 | 1.7 | 7 | 2 | ||
1000 |
8 | .9 | 6 | 2 | ||||||||
Positive Control | 452 | 12.8 | 352 | 41.8 | 162 | 11.8 | 183 | 11.5 | 437 | 22.8 | 502 | 41 |
Dose |
No Activation
(Negative) |
No Activation
(Negative) |
10% RLI
(Negative) |
10% RLI
(Negative) |
10% HLI
(Negative) |
10% HLI
(Negative) |
||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Protocol | Preincubation | Preincubation | Preincubation | Preincubation | Preincubation | Preincubation | ||||||
ug/Plate | Mean | ±SEM | Mean | ±SEM | Mean | ±SEM | Mean | ±SEM | Mean | ±SEM | Mean | ±SEM |
0 |
3 | 1.3 | 5 | 1 | 9 | 2.2 | 4 | .7 | 7 | 1.9 | 4 | .9 |
1 |
7 | 2.5 | ||||||||||
3 |
7 | .9 | 3 | .6 | 8 | 2.1 | 10 | 2 | ||||
10 |
7 | 1.3 | 5 | 2.3 | 6 | .9 | 8 | 2.4 | 8 | 2.3 | 6 | .3 |
33 |
6 | 1.9 | 3 | .6 | 8 | .6 | 9 | 1.5 | 7 | 2.8 | 8 | .7 |
100 |
9 | 1.3 | 4 | .7 | 10 | 1.2 | 6 | .9 | 7 | .3 | 8 | 1.2 |
333 |
2 | .9 | 4 | 1.2 | 6 | .6 | 9 | 2.1 | 6 | .3 | ||
1000 |
4 | .3 | 4 | .6 | ||||||||
Positive Control | 149 | 27.8 | 110 | 9.7 | 116 | 23.4 | 122 | 17.1 | 409 | 14.9 | 246 | 27.1 |
Dose |
No Activation
(Negative) |
No Activation
(Negative) |
10% RLI
(Negative) |
10% RLI
(Negative) |
10% HLI
(Negative) |
10% HLI
(Negative) |
||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Protocol | Preincubation | Preincubation | Preincubation | Preincubation | Preincubation | Preincubation | ||||||
ug/Plate | Mean | ±SEM | Mean | ±SEM | Mean | ±SEM | Mean | ±SEM | Mean | ±SEM | Mean | ±SEM |
0 |
16 | .7 | 16 | 2.1 | 24 | 3.9 | 31 | 3.6 | 31 | 0 | 30 | 3.2 |
1 |
14 | 2.6 | ||||||||||
3 |
16 | 1.2 | 13 | .6 | 32 | 4.1 | 32 | 3.5 | ||||
10 |
20 | 2.3 | 15 | .7 | 25 | 5.7 | 29 | 1.5 | 36 | 2 | 35 | 4.3 |
33 |
22 | 3.9 | 11 | 2.3 | 27 | 3.8 | 26 | 2.3 | 32 | 1.3 | 35 | 1.8 |
100 |
17 | 4.7 | 13 | 2.5 | 29 | 2 | 31 | 3.5 | 29 | .6 | 35 | 2.2 |
333 |
8 | 2.5 | 24 | 6.3 | 34 | 2.2 | 25 | 3 | 39 | .3 | ||
1000 |
29 | 2.5 | 28 | 1.8 | ||||||||
Positive Control | 830 | 6 | 596 | 22.2 | 414 | 16.7 | 409 | 8.5 | 827 | 37.4 | 1072 | 104.4 |
HLI = induced male Syrian hamster liver S9
Chromosomal aberration (CA) data are presented as the percentage of cells with aberrations. To arrive at a statistical call for a trial, analyses were conducted to assess the presence of a dose-response (trend test) and the significance of the individual dose points compared to the vehicle control. The overall result for the CA assay was based on an evaluation of the responses in all trials within an activation condition.
Study Result:Negative |
|||||||||||||||||
Activation |
Trial |
Trial Call |
|||||||||||||||
No Activation |
1 |
Negative |
|||||||||||||||
Induced Rat Liver S9 |
1 |
Negative |
|||||||||||||||
Trial #:1 Activation:No Activation Date:07/25/1985 Harvest Time:10.5 hrs Trial Call:Negative |
|||||||||||||||||
|
Dose |
Total Cells Examined |
Total Aberrations |
Complex Aberrations |
Simple Aberrations |
Other Abs. |
|||||||||||
No. of |
Abs |
% Cells |
No. of |
Abs |
% Cells |
No. of |
Abs |
% Cells |
No. of |
Abs |
% Cells |
||||||
Abs: Aberrations |
|||||||||||||||||
Vehicle Control |
Medium |
100 |
4 |
0.040 |
2.0 |
0 |
0.000 |
0.0 |
4 |
0.040 |
2.0 |
0 |
0.000 |
0.0 |
|||
Test Chemical |
Ethoxylated dodecyl alcohol |
5 |
100 |
0 |
0.000 |
0.0 |
0 |
0.000 |
0.0 |
0 |
0.000 |
0.0 |
0 |
0.000 |
0.0 |
||
15 |
100 |
2 |
0.020 |
2.0 |
0 |
0.000 |
0.0 |
2 |
0.020 |
2.0 |
0 |
0.000 |
0.0 |
||||
50 |
100 |
2 |
0.020 |
2.0 |
0 |
0.000 |
0.0 |
2 |
0.020 |
2.0 |
0 |
0.000 |
0.0 |
||||
Positive Control |
Mitomycin-C |
1 |
100 |
22 |
0.220 |
20.0 |
7 |
0.070 |
7.0 |
15 |
0.150 |
15.0 |
0 |
0.000 |
0.0 |
||
5 |
50 |
23 |
0.460 |
36.0 |
5 |
0.100 |
10.0 |
18 |
0.360 |
28.0 |
0 |
0.000 |
0.0 |
||||
|
Trend |
0.361 |
0.000 |
0.361 |
|
||||||||||||
Probability |
0.359 |
0.000 |
0.359 |
Trial #:1 Activation:Induced Rat Liver S9 Date:07/25/1985 Harvest Time:12.0 hrs Trial Call:Negative |
|||||||||||||||
|
Dose |
Total Cells Examined |
Total Aberrations |
Complex Aberrations |
Simple Aberrations |
Other Abs. |
|||||||||
No. of |
Abs |
% Cells |
No. of |
Abs |
% Cells |
No. of |
Abs |
% Cells |
No. of |
Abs |
% Cells |
||||
Abs: Aberrations |
|||||||||||||||
Vehicle Control |
Medium |
100 |
1 |
0.010 |
1.0 |
0 |
0.000 |
0.0 |
1 |
0.010 |
1.0 |
0 |
0.000 |
0.0 |
|
Test Chemical |
Ethoxylated dodecyl alcohol |
5 |
100 |
1 |
0.010 |
1.0 |
0 |
0.000 |
0.0 |
1 |
0.010 |
1.0 |
0 |
0.000 |
0.0 |
15 |
100 |
0 |
0.000 |
0.0 |
0 |
0.000 |
0.0 |
0 |
0.000 |
0.0 |
0 |
0.000 |
0.0 |
||
50 |
100 |
2 |
0.020 |
2.0 |
0 |
0.000 |
0.0 |
2 |
0.020 |
2.0 |
0 |
0.000 |
0.0 |
||
Positive Control |
Cyclophosphamide |
50 |
50 |
28 |
0.560 |
34.0 |
12 |
0.240 |
16.0 |
16 |
0.320 |
26.0 |
0 |
0.000 |
0.0 |
|
Trend |
0.472 |
0.000 |
0.472 |
|
||||||||||
Probability |
0.318 |
0.000 |
0.318 |
Nonactivation Trial:2Experiment Call:Negative |
|||||||
|
Conc. |
Cloning |
Relative Total |
Mutant Colonies |
Mutant Frequency |
AVG Mutant Frequency |
|
Vehicle Control |
Water |
0 |
110 |
113 |
128 |
39 |
33 |
|
|
108 |
83 |
114 |
35 |
||
|
|
116 |
124 |
84 |
24 |
||
|
|
108 |
80 |
115 |
36 |
||
Test Chemical |
Ethoxylated dodecyl alcohol |
5 |
106 |
107 |
113 |
35 |
30 |
|
|
113 |
109 |
97 |
29 |
||
|
|
115 |
119 |
93 |
27 |
||
10 |
105 |
80 |
139 |
44 |
40 |
||
|
|
107 |
97 |
171 |
53 |
||
|
|
112 |
117 |
78 |
23 |
||
15 |
105 |
107 |
136 |
43 |
41 |
||
|
|
114 |
82 |
144 |
42 |
||
|
|
115 |
71 |
125 |
36 |
||
20 |
104 |
72 |
218 |
70 |
48 |
||
|
|
105 |
74 |
101 |
32 |
||
|
|
117 |
79 |
149 |
42 |
||
30 |
107 |
29 |
114 |
35 |
51* |
||
|
|
110 |
34 |
208 |
63 |
||
|
|
108 |
29 |
180 |
56 |
||
40 |
LETHAL |
|
|||||
|
|
LETHAL |
|||||
|
|
LETHAL |
|||||
Positive Control |
Methyl Methane Sulfonate |
5 |
105 |
60 |
1132 |
360 |
392* |
|
|
115 |
56 |
1120 |
326 |
||
|
|
86 |
23 |
1257 |
489 |
Induced S9 Trial:2Experiment Call:Negative |
|||||||
|
Conc. |
Cloning |
Relative Total |
Mutant Colonies |
Mutant Frequency |
AVG Mutant Frequency |
|
Vehicle Control |
Water |
0 |
112 |
65 |
106 |
32 |
31 |
|
|
113 |
94 |
107 |
32 |
||
|
|
105 |
144 |
81 |
26 |
||
|
|
116 |
98 |
129 |
37 |
||
Test Chemical |
Ethoxylated dodecyl alcohol |
5 |
97 |
96 |
112 |
39 |
33 |
|
|
106 |
108 |
92 |
29 |
||
|
|
106 |
95 |
102 |
32 |
||
10 |
105 |
100 |
91 |
29 |
30 |
||
|
|
100 |
78 |
90 |
30 |
||
|
|
116 |
98 |
112 |
32 |
||
15 |
97 |
56 |
118 |
41 |
39 |
||
|
|
117 |
70 |
121 |
35 |
||
|
|
113 |
61 |
144 |
42 |
||
20 |
105 |
76 |
129 |
41 |
30 |
||
|
|
121r |
72 |
85 |
23 |
||
|
|
112 |
51 |
67 |
20 |
||
30 |
101 |
32 |
120 |
40 |
40 |
||
|
|
105 |
43 |
139 |
44 |
||
|
|
111 |
46 |
117 |
35 |
||
40 |
104 |
13 |
84 |
27 |
39 |
||
|
|
107 |
32 |
164 |
51 |
||
|
|
LETHAL |
|||||
50 |
LETHAL |
|
|||||
|
|
LETHAL |
|||||
|
|
LETHAL |
|||||
Positive Control |
Methyl Methane Sulfonate |
5 |
111 |
43 |
630 |
189 |
360* |
|
|
78 |
31 |
1010 |
432 |
||
|
|
47 |
12 |
646 |
460 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
Test substance was evaluated for its mutagenic potential in B6C3F1 male Mouse by In vivo Mammalian Somatic cell study. The test result was consider to be negative as there was no significant chromosome damage in micronucleated polychromatic erythrocytes.
Link to relevant study records
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data from handbook or collection of data
- Qualifier:
- according to guideline
- Guideline:
- other: Refer below principle
- Principles of method if other than guideline:
- To evaluate the mutagenic potential of test chemical in B6C3F1 male Mouse by In vivo Mammalian Somatic cell study.
- GLP compliance:
- not specified
- Type of assay:
- not specified
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- No data available
- Route of administration:
- intraperitoneal
- Vehicle:
- - Vehicle(s)/solvent(s) used: Phosphate Buffered Saline
- Duration of treatment / exposure:
- 72 hour
- Frequency of treatment:
- 3 times in 72 hours
- Post exposure period:
- No data
- Remarks:
- 0,31.25,62.5 and 125 mg/Kg
- No. of animals per sex per dose:
- 5 animals per sex per dose
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Positive controls; Mitomycin-C
- Route of administration: Intraperitoneal Injection
- Doses / concentrations:0.2 mg/kg - Tissues and cell types examined:
- Polychromatic and normochromatic erythrocytes were screened for the presence of micronuclei.
- Details of tissue and slide preparation:
- Details of tissue and slide preparation
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): 24 hour - Evaluation criteria:
- The erythrocytes were observed for micronuclei. The MN results were tabulated as the mean frequency of micronucleated erythrocytes per 1000 cells per animal, plus or minus the standard error of the mean among animals within a treatment group.
Generally, a test was considered positive if (1) the trend test P value was 0.025 or less or (2) the P value for any single exposure group was 0.025/N or less where N is the number of test chemical treatment groups. Trend test P values between 0.025 and 0.05 were considered to be equivocal if accompanied by a monotonic increase in the frequency of micronuclei over the dose range investigated. All other responses were considered to be negative. - Statistics:
- The frequency of micronucleated cells among NCE or PCE was analyzed by a statistical software package that tested for increasing trend over exposure groups using a one-tailed Cochran-Armitage trend test, followed by pairwise comparisons between each exposure group and the control group. In the presence of excess binomial variation, as detected by a binomial dispersion test, the binomial variance of the Cochran-Armitage test was adjusted upward in proportion to the excess variation. Pairwise comparisons between each treatment group and the concurrent solvent control group were performed using an
unadjusted one-tailed Pearson x2 test that incorporated the calculated variance inflation factor for the study.
Although statistical analyses were used as an important aid in evaluating the test results, statistical significance was not the only determining factor in arriving at an overall call for a chemical. A decision to classify a test as negative, equivocal, or positive for induction of micronuclei in this in vivo assay was based on a broader evaluation of a number of factors that determined the biological relevance of the results, including the appropriateness of the concurrent control data, the magnitude of the observed response and the presence of a dose-dependent increase in the frequency of micronucleated cells.
The percentage of polychromatic erythrocytes (%PCE) data were analyzed by a standard ANOVA to determine if significant PCE suppression or stimulation occurred. - Key result
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- not specified
- Positive controls validity:
- valid
- Remarks on result:
- other: No mutagenic potential
- Additional information on results:
- No data
- Conclusions:
- Test substance was evaluated for its mutagenic potential in B6C3F1 male Mouse by In vivo Mammalian Somatic cell study. The test result was consider to be negative as there was no significant chromosome damage in micronucleated polychromatic erythrocytes.
- Executive summary:
In the study test substance was assessed for its possible mutagenic potential. For this purpose wasIn vivo Mammalian Somatic cell study in B6C3F1 male Mouse. The test substance was administrated by Intraperitoneal Injection by using corn oil as vehicle. The test substance was exposed at the concentration of 0, 0, 31.25, 62.5 and 125 mg/Kg for 72 hours. The dose was administrated thrice in 72 hours .The bone marrow cells were stained and observed for chromosome damage. No significant increase in the frequency of micronucleated polychromatic erythrocytes in treated animals was observed. Therefore test result was consider to be negative as there was no significant chromosome damage in micronucleated polychromatic erythrocytes. Hence the substance cannot be classified as mutant In Vivo.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Data for the various publication was reviewed to determine the mutagenic nature of Dodecan-1-ol, ethoxylated (CAS No; 9002-92-0 EC No; 500-002-6). The studies are as mentioned below:
In Vitro studies
Ames assay
Genetic toxicity in vitro study was assessed for test chemical. For this purpose AMES test was performed .The test material was exposed to Salmonella typhimurium TA100, TA1535, TA98 and TA1537in the presence and absence of metabolic activation S9. The concentration of test material used in the presence and absence of metabolic activation were 0-1000 µg/plate. No mutagenic effects were observed in all strains, in the presence and absence of metabolic activation. Therefore test chemical was considered to be non-mutagenic in Salmonella typhimurium TA100, TA1535, TA98 and TA1537by AMES test. Hence the substance cannot be classified as gene mutant in vitro.
In vitro chromosomal abbreviation study
Genetic toxicity in vitro study was assessed for test chemical. For this purpose in vitro mammalian chromosome aberration test was performed .The test material was exposed to Chinese hamster ovary cells in the presence and absence of metabolic activation S9. The concentration of test material used in the presence and absence of metabolic activation were 0, 5, 15 and 50 µg/mL. Chromosome aberration, Chromosome gaps and breaks were not observed in the presence or absence of metabolic activation. Therefore test chemical was considered to be non - mutagenic in Chinese hamster ovary cells by in vitro mammalian chromosome aberration test. Hence the substance cannot be classified as mutagenic in vitro.
In vitro Mammalian cell gene mutation assay
Genetic toxicity in vitro study was assessed for test chemical. For this purpose in vitro mammalian cell gene mutation was performed .The test material was exposed to mouse lymphoma cells. The concentration of test material used in two experiment were 0,5,19,15,20,30,30,40,50 µg/mL. Mutagenic frequency were not observed in the mammalian cells. Therefore test chemical was considered to be non-mutagenic IN mouse lymphoma cells by in vitro mammalian cell gene mutation. Assay. Hence the substance cannot be classified as mutagenic in vitro.
In vivo studies
In the study test substance was assessed for its possible mutagenic potential. For this purpose wasIn vivo Mammalian Somatic cell study in B6C3F1 male Mouse. The test substance was administrated by Intraperitoneal Injection by using corn oil as vehicle. The test substance was exposed at the concentration of 0, 0, 31.25, 62.5 and 125 mg/Kg for 72 hours. The dose was administrated thrice in 72 hours .The bone marrow cells were stained and observed for chromosome damage. No significant increase in the frequency of micronucleated polychromatic erythrocytes in treated animals was observed. Therefore test result was consider to be negative as there was no significant chromosome damage in micronucleated polychromatic erythrocytes. Hence the substance cannot be classified as mutant In Vivo.
Based on the data summarized, Dodecan-1-ol, ethoxylated (CAS No; 9002-92-0 EC No; 500-002-6) did not induce gene mutation .Hence it is not likely to be mutagenic in vitro and in vivo too.
Justification for classification or non-classification
Thus based on the above annotation and CLP criteria the test chemical Dodecan-1-ol, ethoxylated (CAS No; 9002-92-0 EC No; 500-002-6) not likely to induce gene mutation .Hence it is not likely to be mutagenic in vitro as well as in vivo.
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