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EC number: 219-694-3 | CAS number: 2498-95-5
- 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
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
- Study period:
- 2015-06-26 to 2015-09-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Version / remarks:
- 1998
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- Liver homogenates (S9) from male Wistar rats induced with phenobarbital and β-naphthoflavone (both supplied by Sigma-Aldrich, 82024 Taufkirchen, Germany)
- Test concentrations with justification for top dose:
- 33, 100, 333, 1000, 3650, 7300 µg/plate (with and without metabolic activation)
- Vehicle / solvent:
- Vehicle used: Water, DMSO
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water (The vehicle control with and without S9 mix only contains the vehicle used for the test substance at the same concentration and volume for all tester strains.)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: N-methyl-N'-nitro-N-nitrosoguanidine (MNNG)
- Remarks:
- Without S9 mix: TA1535, TA 100
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water (The vehicle control with and without S9 mix only contains the vehicle used for the test substance at the same concentration and volume for all tester strains.)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylenediamine (NOPD)
- Remarks:
- Without S9 mix: TA 98
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water (The vehicle control with and without S9 mix only contains the vehicle used for the test substance at the same concentration and volume for all tester strains.)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 9-aminoacridine (AAC)
- Remarks:
- Without S9 mix: TA 1537
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water (The vehicle control with and without S9 mix only contains the vehicle used for the test substance at the same concentration and volume for all tester strains.)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- Without S9 mix: E.coli WP2 uvrA
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water (The vehicle control with and without S9 mix only contains the vehicle used for the test substance at the same concentration and volume for all tester strains.)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene (2-AA)
- Remarks:
- With S9 mix: All strains
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation), preincubation
DURATION
- Preincubation period: At 37°C for the duration of about 20 minutes using a shaker
- Exposure duration: 48-72 hours at 37 °C in the dark
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: Decrease in the number of revertants (factor ≤ 0.6), clearing or diminution of the background lawn (= reduced his- or trp- background growth) - Evaluation criteria:
- The test substance was considered positive in this assay if the following criteria were met:
- A dose-related and reproducible increase in the number of revertant colonies, i.e. at least doubling (bacteria strains with high spontaneous mutation rate, like TA 98, TA 100 and E.coli WP2 uvrA) or tripling (bacteria strains with low spontaneous mutation rate, like TA 1535 and TA 1537) of the spontaneous mutation rate in at least one tester strain either without S9 mix or after adding a metabolizing system.
A test substance was generally considered non-mutagenic in this test if:
- The number of revertants for all tester strains were within the historical negative control range under all experimental conditions in at least two experiments carried out independently of each other. - Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- A weak bacteriotoxic effect (decrease in the number of his+) was observed in the standard plate test without metabolic activation only in tester strain TA 98 from 3650 μg/plate onward.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
According to the results of the present study the test substance did not lead to a biologically relevant increase in the number of revertant colonies either without S9 mix or after adding a metabolizing system in two experiments carried out independently of each other (standard plate test and preincubation assay). However, the slight increase in the number of his+ revertants observed in the standard plate test with tester strains TA 100 and TA 98 after the addition of S9 mix did not exceeded the threshold of factor 2, and so these findings have to be regarded as biological irrelevant.
Besides, the results of the negative as well as the positive controls performed in parallel corroborated the validity of this study, since the values fulfilled the acceptance criteria of this study. In this study with and without S9 mix, the number of revertant colonies in the negative controls was within or nearby the range of the historical negative control data for each tester strain. In addition, the positive control substances both with and without S9 mix induced a significant increase in the number of revertant colonies within the range of the historical positive control data. However, in the preincubation test (4th Experiment) with TA 98 the revertant rates of the positive control 2-AA were below the range of our recent historical control. But, the number of his+ revertants of the positive control exceeding the treshold of factor 3 and, therefore it has to be considered that this deviation has no detrimental impact on the validity of this experimental part.
Toxicity: A weak bacteriotoxic effect (decrease in the number of his+) was observed in the standard plate test without metabolic activation only in tester strain TA 98 from 3650 μg/plate onward. In the preincubation assay no bacteriotoxicity (reduced his- or trp- background growth, decrease in the number of his+ or trp+ revertants) was observed up to the highest required concentration. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Reference
Experiment 1 (SPT) |
|||||
Dose (µg/plate) |
Mean number of revertant colonies/3 replicate plates with different strains of Salmonella typhimurium and E. coli |
||||
|
TA1535 |
TA100 |
TA1537 |
TA98 |
WP2 uvrA |
|
|
||||
|
Results without S9 |
||||
Water |
10.7 |
90.7 |
6.7 |
19.7 |
17.3 |
Positive control |
4584.7 |
4176.0 |
1095.3 |
343.3 |
1253.0 |
33 |
5.7 |
96.7 |
7.3 |
11.3 |
21.3 |
100 |
7.0 |
92.0 |
6.7 |
15.0 |
20.3 |
333 |
9.0 |
105.3 |
6.3 |
14.0 |
24.7 |
1000 |
11.7 |
93.7 |
5.3 |
13.7 |
17.7 |
3650 |
9.3 |
83.3 |
4.3 |
8.0 |
13.3 |
7300 |
12.0 |
90.0 |
5.3 |
8.7 |
21.7 |
|
|
||||
|
Results with S9 |
||||
Water |
8.3 |
102.0 |
5.7 |
25.3 |
29.0 |
Positive control |
234.7 |
1842.7 |
116.3 |
1564.0 |
111.0 |
33 |
9.3 |
105.0 |
8.0 |
25.3 |
16.0 |
100 |
8.0 |
100.3 |
7.7 |
21.3 |
20.7 |
333 |
10.0 |
112.3 |
5.7 |
28.0 |
23.3 |
1000 |
11.0 |
116.0 |
9.0 |
31.3 |
20.3 |
3650 |
9.0 |
142.3 |
6.3 |
42.7 |
20.0 |
7300 |
8.7 |
194.3 |
6.7 |
49.0 |
26.0 |
|
|
|
|
|
|
Experiment 2 (PIT) |
|||||
Dose (µg/plate) |
Mean number of revertant colonies/3 replicate plates with different strains of Salmonella typhimurium and E. coli |
||||
|
TA1535 |
TA100 |
TA1537 |
TA98 |
WP2 uvrA |
|
|
||||
|
Results without S9 |
||||
Water |
7.3 |
80.7 |
5.0 |
17.3 |
20.0 |
Positive control |
2417.3 |
1636.7 |
675.3 |
349.7 |
453.3 |
33 |
8.0 |
90.3 |
6.3 |
12.7 |
17.3 |
100 |
9.0 |
102.7 |
5.7 |
19.0 |
18.3 |
333 |
5.7 |
96.0 |
6.0 |
16.7 |
23.7 |
1000 |
10.7 |
99.0 |
8.0 |
17.3 |
22.0 |
3650 |
8.0 |
87.3 |
3.7 |
15.0 |
17.0 |
7300 |
10.3 |
83.3 |
5.3 |
20.3 |
21.0 |
|
|
||||
|
Results with S9 |
||||
Water |
9.0 |
104.0 |
6.0 |
25.7 |
20.7 |
Positive control |
194.0 |
1550.7 |
106.7 |
508.7 |
69.0 |
33 |
9.7 |
107.7 |
7.3 |
22.3 |
29.0 |
100 |
6.7 |
98.0 |
8.7 |
25.0 |
27.3 |
333 |
8.3 |
94.3 |
10.7 |
27.7 |
28.0 |
1000 |
8.0 |
118.3 |
4.7 |
28.0 |
28.0 |
3650 |
7.7 |
140.3 |
6.7 |
42.0 |
26.3 |
7300 |
8.7 |
184.3 |
6.3 |
37.0 |
24.3 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Ames test:
Key
The test substance was tested for its mutagenic potential based on the ability to induce point mutations in selected loci of several bacterial strains, i.e. Salmonella typhimurium and Escherichia coli, in a reverse mutation assay according to OECD guideline 471. The following strains were used: TA 1535, TA 100, TA 1537, TA 98 and E. coli WP2 uvrA in a dose range of 33 μg - 7300 μg/plate . Standard plate test (SPT) and a preincubation test (PIT) both with and without metabolic activation (liver S9 mix from induced rats) were used to assess the mutagenic potential. No precipitation of the test substance was found with and without S9 mix. A weak bacteriotoxic effect was observed only in the standard plate test without S9 mix on tester strain TA 98 from 3650 μg/plate onward. A biologically relevant increase in the number of his+ or trp+ revertants was not observed in the standard plate test or in the preincubation test either without S9 mix or after the addition of a metabolizing system. Thus, under the experimental conditions of this study, the test substance is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay in the absence and the presence of metabolic activation.
Disregarded
In another study (BASF, 1998) the mutagenic potenial of an aqueous solution of the test item (10.8 g/100 g active ingredient) was assessed based on the ability to induce point mutations in selected loci of several bacterial strains, i.e. Salmonella typhimurium (TA 1535, TA 100, TA1537 and TA98) and Escherichia coli (e. coli WP2 uvrA), in a reverse mutation assay (OECD 471). The test concentrations was 180 µg - 45000 µg/plate (all test strains) and 180 µg - 50000 µg/plate with TA 98. No precipitation of the test substance was found. No bacteriotoxic effect was observed. A weakly positive reaction with S-9 mix was observed in TA 100 only at 45000 µg/plate (factor 1.7). Depending on the experiment mutagenicity was observed with metabolic activation in TA 98 from about 10.000 µg - 22.500 µg/plate onward with a maximum increase in the number of his+ revertants by a factor of 8.1 at 30,000 µg/plate. According to the results of the present study, the test material was mutagenic in the Salmonella typhimurium reverse mutation assay under the experimental conditions chosen. However, as impurities in the test substance preparation are suspected as cause of the mutagenic effect this study is disregarded. The study was also rated as disregarded study as an aqueous preparation containing only 10.8 g/100 g active gradient was tested.
Justification for selection of genetic toxicity endpoint
GLP and guideline study
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data is reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the test substance is not considered to be classified for genetic toxicity under Regulation (EC) No 1272/2008.
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