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EC number: - | CAS number: -
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- OECD guideline compliant as at 1987
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- as at 1987
- Deviations:
- yes
- Remarks:
- only 4 strains tested (E. Coli not tested), only plate incorporation assay used.
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Fatty alcohols C13-15 (odd numbered, linear and branched), reaction products with ethylene oxide, sodium chloroacetate and ethanolamine
- Molecular formula:
- R-O-(CH2CH2O)nCH2CO-NH-CH2CH2OH
- IUPAC Name:
- Fatty alcohols C13-15 (odd numbered, linear and branched), reaction products with ethylene oxide, sodium chloroacetate and ethanolamine
- Test material form:
- liquid: viscous
- Details on test material:
- - Name of test material (as cited in study report): AA 15
- Physical state: yellow viscous liquid
Constituent 1
Method
- Target gene:
- TA1535: his G46 rfa- delta uvrB-
TA1537: his C3076 rfa- delta uvrB-
TA98: his D3052 rfa- delta uvrB- R+
TA100: his G46 rfa- delta uvrB- R+
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 induced rat liver S9
- Test concentrations with justification for top dose:
- Plate incorporation assay up to 10,000 µg Fe/plate + and - S9. Pre-incubation assay
- Vehicle / solvent:
- Vehicle used: distilled water
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- Remarks:
- without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene for all strains
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation);
DURATION
- Exposure duration: 48 hours
- Expression time (cells in growth medium): 48 hours concurrent with exposure
SELECTION AGENT (mutation assays): minimal agar
NUMBER OF REPLICATIONS: doses were tested in triplicate in the plate incorporation assay . 5 dose levels were tested.
DETERMINATION OF CYTOTOXICITY
- Method:
• one Salmonella strain (TA98), based on the assumption that all strains used show a similar toxic response with and wo activation.
• concentrations: 0, 1.6, 8, 40, 200, 1000 and 5000 µg/plate.
• analysis of appearance of a complete bacterial lawn as seen under a dissecting microscope after 24 hours incubation at 37°C. - Evaluation criteria:
- A statistically significant increase in the mean number of revertants that exceeds twice the concurrent negative control, plus evidence of a dose response relationship.
- Statistics:
- • analysis of variance on each set of data to obtain the F-statistic
• in case of statistical significance (p<0.05) and dose related increases correlation coefficient is calculated for the response range and the significance of the result is determined from standard tables.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Remarks:
- E. coli WP2 uvrA, not used in this study
- Metabolic activation:
- not applicable
- Genotoxicity:
- not determined
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Remarks:
- AMINOL A15 LA 438-7 (FB-4136)
- Positive controls validity:
- not applicable
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: at 5000 µg/plate with and without activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: at 5000 µg/plate with and without activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: at 5000 µg/plate with and without activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: at 5000 µg/plate with and without activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
Any other information on results incl. tables
GENOTOXIC EFFECTS:
- The test item caused restricted growth of the background lawns for all four strains, both with and without S-9, at 5000 µg/plate.
- No dose related increases in revertant rates were seen with any of the strains except for TA1537 and TA98 without activation at the highest dose. The effects occur only at the highest dose and are deemed rather survivors of the cytotoxic effect than mutants. In addition the effects are neither dose related nor reproducible in experiment 2 and therefore not regarded as a positive mutagenic response.
- High concentrations of the test item caused decreases in numbers of revertants (except for the two concentrations nentioned above).
- All solvent (negative) controls gave counts of revertants within normal ranges
- All positive controls gave numbers of induced revertants within expected ranges demonstrating the sensitivity of the assay and the metabolising activity of the S-9 mix.
PRECIPITATION CONCENTRATION: None reported
Table 1: Pretest
Strain |
% |
Concentration of Test Substance (µg/plate)* |
||||||
0 |
1.6 |
8 |
40 |
200 |
1000 |
5000 |
||
TA98 |
0 |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
TA98 |
10 |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
* These are actual amounts of test substance added and correspond to solutions of test compound with concentrations from 16 µg/ml to 50 mg/ml.
+ = restricted growth
+ = normal growth
Table 2: MEAN NUMBER OF REVERTANTS PER PLATE FOR THE TEST ITEM
Strain |
% |
Concentration of Test Substance (µg/plate) |
||||||
0 |
8 |
40 |
200 |
1000 |
5000 |
PC |
||
TA1535 |
0 |
9.0 |
13.0 |
9.0 |
6.7 |
6.0 |
1.7 |
322.3 |
TA1537 |
0 |
3.0 |
5.0 |
3.7 |
4.0 |
1.7 |
1.7 |
1013.0 |
TA98 |
0 |
10.7 |
11.7 |
5.3 |
5.3 |
4.7 |
3.7 |
173.3 |
TA100 |
0 |
93.0 |
88.3 |
80.7 |
77.0 |
72.0 |
57.3 |
287.3 |
TA1535 |
10 |
11.0 |
12.3 |
7.7 |
10.7 |
7.0 |
4.7 |
95.7 |
TA1537 |
10 |
5.7 |
3.3 |
6.0 |
5.0 |
3.3 |
3.3 |
35.7 |
TA98 |
10 |
16.0 |
13.7 |
11.3 |
9,7 |
11.0 |
9.0 |
523.0 |
TA100 |
10 |
92.0 |
86.0 |
89.7 |
80.3 |
72.7 |
72.0 |
639.7 |
PC = Positive control
Table3: MEAN NUMBER OF REVERTANTS PER PLATE FOR THE TEST ITEM
Strain |
% |
Concentration of test substance (µg/plate) |
|
|||||
0 |
8 |
40 |
200 |
1000 |
5000 |
PC |
||
TA1535 |
0 |
5.3 |
8.3 |
4.7 |
6.3 |
4.7 |
1.7(a) |
262.3 |
TA1537 |
0 |
6.3 |
7.0 |
5.7 |
5.3 |
2.7 |
58.3(a) |
925.7 |
TA98 |
0 |
10.0 |
13.7 |
10.0 |
9.0 |
9.0 |
25.0(a) |
138.0 |
TA100 |
0 |
112.0 |
106.7 |
81.3 |
84.0 |
67.3 |
58.0(a) |
218.3 |
TA1535 |
10 |
10.0 |
9.7 |
8.7 |
6.7 |
4.3 |
3.7(a) |
186.7 |
TA1537 |
10 |
6.7 |
4.3 |
4.3 |
4.3 |
2.3 |
3.3(a) |
34.0 |
TA98 |
10 |
13.0 |
8.7 |
14.7 |
10.3 |
4.3 |
5.3(a) |
138.3 |
TA100 |
10 |
104.0 |
94.7 |
81.7 |
89.7 |
72.7 |
67.7(a) |
369.3 |
PC = Positive control
a = Reduced background lawn
Applicant's summary and conclusion
- Conclusions:
- Under the test conditions, test substance is not mutagenic with and without metabolic activation in Salmonella typhimurium strains TA1535, TA1537, TA98 and TA100, up to 5000 µg/plate.
- Executive summary:
The test item was tested in vitro by the Ames plate incorporation method for its ability to induce mutations in four histidine dependent auxotrophic mutants of Salmonella typhimurium strains TA1535, TA1537, TA98 and TA100 according to OECD 471 as at 1987.
Two independent mutation tests were performed, each in both the presence and absence of a metabolic activation system (S-9 mix) derived from the livers of Aroclor 1254 treated rats. The bacteria were exposed to the test material dissolved in Dimethylsulphoxide, which was also the solvent control. Based on the results of a preliminary toxicity rangefinder, 5000 µg/plate of AA 15 was chosen as the highest dose level to be used, with lower dose levels of 1000, 200, 40 and 8 µg/plate.
All solvent (negative) controls gave counts of revertants within normal ranges.
All positive controls gave numbers of induced revertants within expected ranges demonstrating the sensitivity of the assay and the metabolising activity of the S-9 mix.
The test item produced no significant increases in the number of revertants, with any of the tester strains, in either of the two experiments performed in both the presence and absence of metabolic activation, when assayed up to 5000 µg/plate.
Under the test conditions, test substance is not mutagenic in Salmonella typhimurium strains with and without metabolic activation, up to 5000 µg/plate.
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