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EC number: 269-027-5 | CAS number: 68171-38-0
- 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:
- 19 Jan - 23 Mar 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted in 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Amt für Arbeitsschutz - Arbeitnehmerschutz, Behörde für Gesundheit und Verbraucherschutz, Hamburg, Germany
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1323-39-3/29013-28-3
- IUPAC Name:
- 1323-39-3/29013-28-3
- Test material form:
- solid
Constituent 1
Method
- Target gene:
- his operon
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of male rats treated with Aroclor 1254
- Test concentrations with justification for top dose:
- 31.6, 100, 316, 1000, 3160 and 5000 µg/plate with and without metabolic activation
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol (concentration in vehicle: 10 ng/mL or 20 ng/mL)
- Justification for choice of solvent/vehicle: Due to the limited solubility of the test substance in water and DMSO, ethanol was selected as vehicle.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Sodium Azide (SA), 2-Nitrofluorene (2-NF), 9-Aminoacridine (9-AA), Mitomycin C (MC), Benzo(a)pyrene (BaP), 2-Aminoanthracene (2-AA)
- Remarks:
- -S9: 2-NF (10 µg/pl in DMSO; TA 98); SA (10 µg/pl in water; TA 100 and TA 1535); 9-AA (100 µg/pl in ethanol; TA 1537), MC (10 µg/pl in water; TA 102); +S9: 2-AA (2 µg/pl in DMSO; TA 100 and TA 1535); BaP (10 µg/pl in DMSO; TA 98, TA 102 and TA 1537)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
First experiment: in agar (plate incorporation)
Second experiment: pre-incubation
DURATION
- Preincubation period: 20 min (second experiment)
- Exposure duration: 48 - 72 h (first and second experiment)
NUMBER OF REPLICATIONS: triplicates each in two independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: reduction in the number of spontaneous revertants by at least 50%, a clearing or diminution of the background lawn or by the degree of survival of the treated cultures - Evaluation criteria:
- A test item is considered to have mutagenic potential, if a significant (p ≤ 0.05) increase of revertant colonies per plate is determined in both experiments (increase factor ≥ 2 for TA 98, TA 100, TA 1535 and TA 1537 or increase factor ≥ 1.5 for TA 102) in at least one strain or a concentration-related increase over the range tested is observed.
Positive results have to be reproducible and the histidine independence of the revertants has to be confirmed by streaking random samples on histidine-free agar plates.
Biological relevance of the results should be considered first.
A test item for which the results do not meet the above mentioned criteria is considered as non-mutagenic in the AMES test. - Statistics:
- Mean values and standard errors were calculated.
Statistical significance was determined via U-test according to MANN and WHITNEY (increase in revertants). In case that a concentration-related increase over the range tested was observed, a Spearman's rank correlation coefficient was applied.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- 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:
- no cytotoxicity, but tested up to precipitating concentrations
- 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:
- no cytotoxicity, but tested up to precipitating concentrations
- 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 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- 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 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: The test item was fully soluble in stock concentrations of 10 and 20 mg/mL. Stock dilutions with higher concentrations (31.6 and 50 mg/mL or 63.2 and 100 mg/mL (corresponding to final concentrations of 3160 or 5000 µg/plate)) were emulsions. Precipitation was noted at 5000 µg/plate in all strains.
- Other: For the positive control substances, no respective solvent control was included. However, due to the range of the mutagenic response, a comparison to the vehicle control ethanol is considered as acceptable.
RANGE-FINDING/SCREENING STUDIES:
A preliminary test was performed in tester strain TA 100 to determine cytotoxcity. Concentrations ranging from 0.316 to 5000 µg/plate were tested in a plate incorporation test without and with metabolic activation. No signs of cytotoxicity were noted in any concentration. Precipitation was observed at 5000 µg/plate. Based on the results of the preliminary study, 5000 µg/plate was chosen as maximum dose for the main study.
COMPARISON WITH HISTORICAL CONTROL DATA:
The mutant frequencies of the solvent controls were within the range of historical control data for any strain. Furthermore, the results of the positive control cultures were within the range of the historical data.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
To prevent cytotoxicity of the solvent ethanol in the preincubation test, the volume of the test item and negative control was reduced from the generally employed 100 µL to 50 µL per plate as the preincubation test is more sensitive than the plate incorporation test.
Any other information on results incl. tables
Table 2. Results of the plate incorporation test
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate ± standard deviation |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA 100 |
TA 102 |
TA 1535 |
TA 98 |
TA 1537 |
||
– |
0 (100 µL/plate) |
173.0 ± 17.3± |
277.0 ± 21.8 |
26.3 ± 2.3 |
29.0 ± 3.6 |
7.7 ± 2.1 |
– |
31.6 |
152.3 ± 20.2 |
265.0 ± 11.4 |
25.3 ± 1.5 |
30 ± 7.9 |
4.3 ± 1.2 |
– |
100 |
158.0 ± 6.0 |
267.3 ± 7.6 |
28.0 ± 3.6 |
26.7 ± 9.0 |
4.3 ± 1.2 |
– |
316 |
134 ± 21.3 |
268.3 ± 7.8 |
29.7 ± 6.7 |
30.0 ± 3.6 |
4.7 ± 2.1 |
– |
1000 |
160 ± 8.9 |
269.3 ± 7.8 |
37.3 ± 2.9 |
29.7 ± 0.6 |
5.0 ± 3.5 |
– |
3160 |
164.3 ± 2.5 |
262.0 ± 14.4 |
28.0 ± 8.9 |
29.3 ± 1.2 |
5.3 ± 0.6 |
– |
5000 |
170p ± 2.0 |
247.0p ± 2.0 |
27.7p ± 3.5 |
33.3p ± 9.0 |
2.7p ± 0.6 |
– |
Positive controls |
SA |
MC |
SA |
2NF |
9AA |
Mean No. of colonies/plate ± SD |
1023.3 ± 50.0 |
1119.3 ± 7.0 |
130.7 ± 17.6 |
116.7 ± 6.0 |
61 ± 3.6 |
|
+ |
0 (100 µL/plate) |
146.3 ± 15.1 |
266.7 ± 24.8 |
26.7 ± 4.0 |
40.7 ± 6.7 |
6.7 ± 2.9 |
+ |
31.6 |
121.7 ± 0.6 |
251.0 ± 1.0 |
27.7 ± 1.2 |
36.0 ± 5.2 |
6.0 ± 1.0 |
+ |
100 |
116.7 ± 7.0 |
255.3 ± 4.2 |
32.3 ± 6.4 |
30.3 ± 0.6 |
7.3 ± 1.5 |
+ |
316 |
113.7 ± 6.4 |
282.0 ± 2.6 |
29.7 ± 3.1 |
29.0 ± 1.7 |
5.0 ± 1.0 |
+ |
1000 |
109.3 ± 5.0 |
221.3 ± 98.2 |
26.3 ± 1.2 |
27.0 ± 1.0 |
4.3 ± 0.6 |
+ |
3160 |
164.0 ± 5.2 |
272.0 ± 3.6 |
25.3 ± 2.5 |
27.7 ± 2.9 |
4.7 ± 1.5 |
+ |
5000 |
148.0p ± 22.5 |
270.7p ± 3.1 |
25.3p ± 1.2 |
32p ± 2.0 |
2.3p ± 0.6 |
+ |
Positive controls |
2AA |
BaP |
2AA |
BaP |
BaP |
Mean No. of colonies/plate ± SD |
986.3± 2.1 |
1081.7± 10.5 |
125.3 ± 18.0 |
120.7± 3.5 |
62.7± 0.6 |
SA = Sodium Azide
MC = Mitomycin C
2NF = 2-Nitrofluorene
9AA = 9 -Aminoacridine
2AA = 2 -Aminoanthracene
BaP = Benzo(a)pyrene
SD = standard deviation
p = precipitate
Table 3. Results of the preincubation test
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate ± standard deviation |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA 100 |
TA 102 |
TA 1535 |
TA 98 |
TA 1537 |
||
– |
0 (50 µL/plate) |
147.7± 17.2 |
263.0 ± 1.0 |
19.3 ± 3.8 |
31.0 ± 8.0 |
6.0 ± 1.0 |
– |
31.6 |
147.3 ± 6.1 |
279.7 ± 11.6 |
20.3 ± 1.2 |
26.0 ± 2.0 |
7.3 ± 2.9 |
– |
100 |
159.3 ± 3.8 |
280.3 ± 9.0 |
25.3 ± 4.0 |
24.7 ± 4.2 |
8.3 ± 1.2 |
– |
316 |
137.0 ± 3.0 |
282.7 ± 8.0 |
19.7 ± 2.1 |
26.0 ± 2.0 |
5.7 ± 1.2 |
– |
1000 |
137.0 ± 3.6 |
283.7 ±3.2 |
19.0 ± 1.0 |
23.3 ± 1.5 |
6.7 ± 1.5 |
– |
3160 |
117.0 ± 114.0 |
260.0 ± 16.5 |
23.7 ± 1.5 |
39.0 ± 3.5 |
5.7 ± 0.6 |
– |
5000 |
103.0p ± 2.0 |
245.3p ± 0.6 |
8.7p ± 0.6 |
14.0p ± 2.0 |
3.3p ± 2.3 |
– |
Positive controls |
SA |
MC |
SA |
2NF |
9AA |
Mean No. of colonies/plate ± SD |
882.7 ± 16.8 |
1057.7 ± 57.0 |
147.7 ± 4.0 |
164.7 ± 8.5 |
67.3 ± 0.6 |
|
+ |
0 (50 µL/plate) |
134.3 ± 4.2 |
271.3 ± 3.1 |
20.7 ± 3.8 |
29.0 ± 4.4 |
7.3 ± 1.2 |
+ |
31.6 |
128.0 ± 1.7 |
276.0 ± 12.8 |
27.0 ± 1.0 |
32.0 ± 1.0 |
7.0 ± 2.6 |
+ |
100 |
134.7 ± 8.1 |
271.7 ± 0.6 |
26.3 ± 0.6 |
32.3 ± 0.6 |
5.3 ± 2.1 |
+ |
316 |
140.7 ± 30.7 |
268.3 ± 2.1 |
28.7± 2.1 |
30.3 ± 2.1 |
7.7 ± 0.6 |
+ |
1000 |
138.3 ± 1.5 |
277.0 ± 13.9 |
26.3 ± 0.6 |
28.0 ± 1.7 |
7.7 ± 0.6 |
+ |
3160 |
122.0 ± 9.6 |
272.3 ± 1.5 |
27.0 ± 1.0 |
28.7± 0.63 |
4.0 ± 1.0 |
+ |
5000 |
102.0p ± 2.6 |
244.0p ± 1.0 |
8.0p ± 1.0 |
13.7p ± 1.2 |
2.0p ± 0.0 |
+ |
Positive controls |
2AA |
BaP |
2AA |
BaP |
BaP |
Mean No. of colonies/plate ± SD |
889.3 ± 12.7 |
1089.0 ± 14.7 |
15.03 ± 1.5 |
168.3 ± 3.2 |
61.3 ± 10.8 |
SA = Sodium Azide
MC = Mitomycin C
2NF = 2-Nitrofluorene
9AA = 9 -Aminoacridine
2AA = 2 -Aminoanthracene
BaP = Benzo(a)pyrene
SD = standard deviation
p = precipitate
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative.
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