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EC number: 608-554-0 | CAS number: 3090-56-0
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Ames: No mutagenic effect was detected.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016-03-08 to 2016-03-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- 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
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: 230-2015
- Expiration date of the lot/batch: 17 Nov 2017 - Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix from rat livers induced with phenobarbital and β-naphthoflavone
- Test concentrations with justification for top dose:
- 0; 33; 100; 333; 1000; 2500 and 5000 μg/plate
In agreement with the recommendations of current guidelines 5 mg/plate were selected as maximum test dose at least in the 1st Experiment. - Vehicle / solvent:
- - Vehicle used: DMSO
- Justification for choice of solvent/vehicle: Due to the insolubility of the test substance in water, DMSO was used as vehicle, which had been demonstrated to be suitable in bacterial reverse mutation tests and for which historical control data are available. - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene (2-AA)
- Remarks:
- with metabolic activation, strains: TA 1535, TA 100, TA 1537, TA 98, E. coli WP2 uvrA
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: N-methyl-N'-nitro-N-nitrosoguanidine (MNNG)
- Remarks:
- without metabolic activation, strains: TA 1535, TA 100
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylenediamine (NOPD)
- Remarks:
- without metabolic activation, strain: TA 98
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without metabolic activation, strain: TA 1537
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- without metabolic activation, strain: E. coli WP2 uvrA
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Preincubation period: about 20 minutes
- Exposure duration: 48 – 72 hours
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- decrease in the number of revertants (factor ≤ 0.6)
- clearing or diminution of the background lawn - Evaluation criteria:
- Acceptance criteria
Generally, the experiment was considered valid if the following criteria were met:
- The number of revertant colonies in the negative controls was within the range of the historical negative control data for each tester strain.
- The sterility controls revealed no indication of bacterial contamination.
- The positive control substances both with and without S9 mix induced a distinct increase in the number of revertant colonies within the range of the historical positive control data or above.
- Fresh bacterial culture containing approximately 10E^9 cells per mL were used.
Assessment 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 data range under all experimental conditions in at least two experiments carried out independently of each other. - Statistics:
- No statistical analysis performed.
- Key result
- Species / strain:
- other: Salmonella strains TA 1535, TA 100, TA 1537, TA 98 and Escherichia coli WP2 uvrA
- 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
- Precipitation: No test substance precipitation was found with and without S9 mix.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
No bacteriotoxic effect (reduced his- or trp- background growth, decrease in the number of his+ or trp+ revertants) was observed in the standard plate or preincubation test up to the highest required concentration.
Reference
Experiment 1 (standard plate test):
Dose (µg/plate) |
Mean number of revertant colonies/3 replicate plates (± S.D.) with different strains of Salmonella typhimurium and E. coli |
||||
TA1535 |
TA100 |
TA1537 |
TA98 |
WP2 uvrA |
|
Results without S9 |
|||||
DMSO |
9.7 ± 3.1 |
92.7 ± 3.5 |
6 ± 2.6 |
24.3 ± 5 |
24.3 ± 3.8 |
33 |
11.7 ± 1.5 |
99.7 ± 11 |
7.7 ± 2.5 |
26.3 ± 1.5 |
25 ± 11.5 |
100 |
11.3 ± 6.7 |
97.7 ± 13.6 |
9.3 ± 2.5 |
19.3 ± 4.9 |
26.7 ± 8.5 |
333 |
12 ± 1 |
109.7 ± 15.6 |
9.3 ± 2.1 |
30.3 ± 4.6 |
23.7 ± 3.2 |
1000 |
14.3 ± 3.5 |
90 ± 3.6 |
13 ± 5.3 |
28 ± 8.2 |
25.7 ± 2.5 |
2500 |
8.7 ± 4 |
101.3 ± 4.7 |
7 ± 3.6 |
28.7 ± 6.4 |
22.3 ± 6.5 |
5000 |
15.3 ± 3.8 |
118.7 ± 25.1 |
6.3 ± 1.2 |
28.7 ± 2.3 |
31.7 ± 1.2 |
MNNG (5.0) |
5349.3 ± 493.9 |
5244 ± 266.4 |
|||
AAC (100) |
342.7 ± 263.6 |
||||
NOPD (10) |
902 ± 60.1 |
||||
4-NQO (5) |
1366.3 ± 42.6 |
||||
Results with S9 |
|||||
DMSO |
12 ± 2.6 |
101.3 ± 12 |
9.7 ± 1.2 |
31.7 ± 6 |
34.7 ± 6 |
33 |
14 ± 1.7 |
104.7 ± 13.7 |
9.3 ± 4.5 |
36.3 ± 2.1 |
32 ± 7.2 |
100 |
16.7 ± 9.9 |
116 ± 12.5 |
9 ± 2.6 |
27.3 ± 2.5 |
21 ± 5.6 |
333 |
12.7 ± 5.5 |
104 ± 13 |
11.3 ± 4.2 |
32.3 ± 5.1 |
23 ± 3.5 |
1000 |
11 ± 6 |
103.7 ± 4.5 |
12.3 ± 2.1 |
33.3 ± 6.4 |
33 ± 10.4 |
2500 |
15.3 ± 5.5 |
86 ± 14.8 |
12.7 ± 1.5 |
35.3 ± 1.5 |
43.3 ± 12.7 |
5000 |
15.3 ± 3.5 |
138.3 ± 14.6 |
12 ± 3 |
31.3 ± 6.7 |
35 ± 11.5 |
2-AA (2.5) |
221.7 ± 22 |
2170.3 ± 95.7 |
149.7 ± 8 |
1595 ± 182.6 |
|
2-AA (60.0) |
95.7 ± 8.3 |
Experiment 2 (preincubation test):
Dose (µg/plate) |
Mean number of revertant colonies/3 replicate plates (± S.D.) with different strains of Salmonella typhimurium and E. coli |
||||
TA1535 |
TA100 |
TA1537 |
TA98 |
WP2 uvrA |
|
Results without S9 |
|||||
DMSO |
9 ± 2.6 |
90.3 ± 10.1 |
9.7 ± 2.9 |
17.7 ± 3.2 |
23.7 ± 2.1 |
33 |
6 ± 2 |
83 ± 5 |
5 ± 1 |
16 ± 4.6 |
20.7 ± 3.2 |
100 |
10.7 ± 2.9 |
90.3 ± 15.9 |
5.3 ± 1.5 |
20.3 ± 1.5 |
21.7 ± 5.1 |
333 |
8 ± 2.6 |
100.3 ± 9.1 |
11.3 ± 4.5 |
20 ± 3 |
23.3 ± 5.5 |
1000 |
10.7 ± 5.5 |
87.7 ± 2.5 |
6 ± 2 |
17.7 ± 2.5 |
25 ± 8.7 |
2500 |
6.7 ± 4.5 |
111 ± 3.6 |
10 ± 2.6 |
24.3 ± 3.2 |
27.7 ± 6.5 |
5000 |
11 ± 1.7 |
120 ± 13.1 |
8.7 ± 3.5 |
13.7 ± 7.1 |
21.7 ± 5.5 |
MNNG (5.0) |
4131 ± 382.4 |
3850.7 ± 46.8 |
|||
AAC (100) |
1227.7 ± 53.5 |
||||
NOPD (10) |
965 ± 9.5 |
||||
4-NQO (5) |
651 ± 14.4 |
||||
Results with S9 |
|||||
DMSO |
9.3 ± 2.1 |
99.7 ± 9.1 |
10.7 ± 0.6 |
27.3 ± 8.1 |
27.3 ± 4 |
33 |
7.3 ± 3.1 |
91 ± 6.1 |
12.3 ± 2.3 |
23 ± 2.6 |
30.7 ± 8 |
100 |
9.3 ± 1.5 |
91.3 ± 9.5 |
13.7 ± 3.1 |
36 ± 3.6 |
26.7 ± 2.1 |
333 |
7.3 ± 3.1 |
92.3 ± 15.5 |
10 ± 2 |
25.7 ± 5.9 |
27 ± 8.7 |
1000 |
10.3 ± 1.5 |
92.3 ± 20.6 |
8 ± 2.6 |
30.3 ± 3.1 |
27.3 ± 1.2 |
2500 |
6.7 ± 3.5 |
112.7 ± 10 |
13.7 ± 1.2 |
31.7 ± 2.9 |
28 ± 5.6 |
5000 |
10.3 ± 2.9 |
130.7 ± 2.5 |
11.3 ± 3.5 |
25.7 ± 7.8 |
28.3 ± 9.9 |
2-AA (2.5) |
107.7 ± 11.9 |
1173 ± 15.7 |
79.3 ± 17.7 |
903.3 ± 181 |
|
2-AA (60.0) |
93.3 ± 16.2 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Ames
The study tested the mutagenicity of the test substance. The study was conducted according to OECD TG 471. The standard plate and preincubation tests were performed. Both were done with and without the addition of a metabolizing system obtained from rat liver (S-9 mix) using the Salmonella strains TA 1535, TA 100, TA 1537, TA 98 and Escherichia coli WP2 uvrA. No cytotoxicity was observed independent on strain and experimental conditions. All tests and strains showed a negative effect for genotoxicity. Therefore the test substance was considered non mutagenic in this study under the corresponding conditions.
Justification for classification or non-classification
Genetic toxicity
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008, as amended for the eighth time in Regulation (EU) No 2016/218. As a result the substance is considered to be not classified as mutagenic.
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