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EC number: 482-400-9 | CAS number: 138776-88-2
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline Study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted 21 Jul 1997
- Deviations:
- yes
- Remarks:
- 2-Aminoanthracene is used as the sole indicator of the efficacy of the S9-mix.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- BASF SE, Experimental Toxicology and Ecology, 67056 Ludwigshafen, Germany
- Type of assay:
- bacterial reverse mutation assay
Test material
- Test material form:
- solid - liquid: suspension
- Details on test material:
- - Name of test material (as cited in study report): L4-Ligand
- Physical state: Solid, white
- Analytical purity: 97.0 g/100 g
- Lot/batch No.: 0005473663
- Stability under test conditions: The stability of the test substance under storage conditions throughout the study period is guaranteed until 01 Feb 2013
- Storage condition of test material: Room temperature (protected from humidity; N2 conditions)
Constituent 1
Method
- Target gene:
- his and trp operon
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with phenobarbital i.p. and β-naphthoflavone orally.
- Test concentrations with justification for top dose:
- 0, 33, 100, 333, 1000, 2500 and 5 000 μg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle: Due to the insolubility of the test substance in ultrapure water, ethanol was used as vehicle, which had been demonstrated to be suitable in bacterial reverse mutation tests and for which historical control data are available.
Controlsopen allclose all
- 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 S9 mix for all strains
- Positive controls:
- yes
- Positive control substance:
- other: N-methyl-N'-nitro-N-nitrosoguanidine (MNNG)
- Remarks:
- without S9 mix for strains TA 1535, TA 100
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylenediamine (NOPD)
- Remarks:
- without S9 mix for strain TA 98
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without S9 mix for strain 1537
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- without S9 mix for strain E. coli WP2 uvrA
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 - 72 hours
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency; relative total growth - Evaluation criteria:
- The test substance is considered positive in this assay if the following criteria are met:
• A dose-related and reproducible increase in the number of revertant colonies, i.e. about doubling of the spontaneous mutation rate in at least one tester strain either without S9 mix or after adding a metabolizing system.
A test substance is 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.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: A weak bacteriotoxic effect was occasionally observed in the SPT depending on the strain and test conditions from about 1000 μg/plate onward. In the PIT no bacteriotoxicity was observed up to the highest required concentration.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Test substance precipitation was found from about 2 500 μg/plate onward only without S9 mix. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1. Test results of experiment 1 (standard plate test).
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 3 plates ± Standard deviation) |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA 100 |
TA1535 |
E. coli |
TA98 |
TA1537 |
||
– |
0 |
78 ± 7 |
11 ± 1 |
56 ± 8 |
31 ± 3 |
9 ± 3 |
– |
33 |
73 ± 21 |
11 ± 1 |
54 ± 10 |
28 ± 7 |
7 ± 2 |
– |
100 |
78 ± 1 |
11 ± 1 |
52 ± 3 |
23 ± 3 |
10 ± 4 |
– |
333 |
80 ± 8 |
11 ± 1 |
52 ± 8 |
30 ± 3 |
7 ± 2 |
– |
1000 |
83 ± 15 |
11 ± 2 |
50 ± 7 |
26 ± 1 |
5 ± 2 |
– |
2500 |
72 ± 7P |
11 ± 1P |
47 ± 11P |
30 ± 9 P |
5 ± 4 P |
- |
5000 |
76 ± 16P |
10 ± 2P |
41 ± 3 P |
24 ± 5 P |
6 ± 3 P |
Positive controls, –S9 |
Name |
MNNG |
MNNG |
4NQO |
4NOPD |
AAC |
Concentrations (μg/plate) |
5 |
5 |
5 |
10 |
100 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
655 ± 57 |
625 ± 54 |
940 ± 24 |
636 ± 67 |
446 ± 31 |
|
+ |
0 |
80 ± 10 |
11 ± 1 |
49 ± 10 |
36 ± 8 |
8 ± 2 |
+ |
33 |
86 ± 17 |
13 ± 2 |
43 ± 6 |
30 ± 3 |
8 ± 1 |
+ |
100 |
73 ± 4 |
13 ± 3 |
53 ± 5 |
42 ± 3 |
10 ± 6 |
+ |
333 |
82 ± 13 |
12 ± 2 |
47 ± 10 |
35 ± 8 |
8 ± 1 |
+ |
1000 |
75 ± 12 |
12 ± 1 |
44 ± 7 |
34 ± 5 |
7 ± 5 |
+ |
2500 |
89 ± 5P |
12 ± 1P |
50 ± 7 P |
38 ± 6 P |
8 ± 2 P |
+ |
5000 |
82 ± 15P |
11 ± 1P |
54 ± 8 P |
30 ± 3 P |
7 ± 1 P |
Positive controls, +S9 |
Name |
2AA |
2AA |
2AA |
2AA |
2AA |
Concentrations (μg/plate) |
2.5 |
2.5 |
60 |
2.5 |
2.5 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
1198 ± 125 |
146 ± 31 |
255 ± 13
|
968 ± 11 |
155 ± 7 |
MNNG = N-methyl-N-nitro-N-nitrosoguanidine
4NQO = 4-nitroquinoline-N-oxide
4NOPD = 4-nitroquinoline-N-oxide
AAC = 9-aminoacridine
2AA = 2-Aminoanthracene
P = Precipitate
Table 2: Test results of experiment 2 (preincubation test).
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 3 plates ± Standard deviation) |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA 100 |
TA1535 |
E. coli |
TA98 |
TA1537 |
||
– |
0 |
74 ± 7 |
12 ± 1 |
37 ± 4 |
19 ± 1 |
7 ± 2 |
– |
33 |
82 ± 7 |
12 ± 3 |
39 ± 6 |
20 ± 5 |
7 ± 1 |
– |
100 |
76 ± 8 |
13 ± 2 |
36 ± 8 |
20 ± 3 |
7 ± 3 |
– |
333 |
76 ± 7 |
11 ± 3 |
35 ± 10 |
21 ± 5 |
7 ± 2 |
– |
1000 |
76 ± 3 |
12 ± 2 |
37 ± 7 |
19 ± 2 |
7 ± 1 |
– |
2500 |
73 ± 7P |
12 ± 1P |
37 ± 6P |
21 ± 2 P |
6 ± 2 P |
- |
5000 |
73 ± 3P |
12 ± 2P |
38 ± 6P |
20 ± 4 P |
6 ± 2 P |
Positive controls, –S9 |
Name |
MNNG |
MNNG |
4NQO |
4NOPD |
AAC |
Concentrations (μg/plate) |
5 |
5 |
5 |
10 |
100 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
869 ± 36 |
758 ± 24 |
648 ± 88 |
541 ± 29 |
367 ± 28 |
|
+ |
0 |
83 ± 11 |
12 ± 2 |
44 ± 4 |
24 ± 3 |
8 ± 2 |
+ |
33 |
86 ± 9 |
12 ± 2 |
48 ± 3 |
27 ± 4 |
7 ± 2 |
+ |
100 |
83 ± 6 |
12 ± 3 |
44 ± 4 |
25 ± 4 |
8 ± 2 |
+ |
333 |
79 ± 5 |
11 ± 3 |
40 ± 3 |
25 ± 4 |
6 ± 2 |
+ |
1000 |
79 ± 4 |
14 ± 1 |
45 ± 8 |
21 ± 4 |
8 ± 1 |
+ |
2500 |
71 ± 7P |
11 ± 2P |
40 ± 6P |
23 ± 3 P |
7 ± 2 P |
+ |
5000 |
75 ± 8P |
12 ± 3P |
41 ± 3P |
21 ± 3 P |
7 ± 0 P |
Positive controls, +S9 |
Name |
2AA |
2AA |
2AA |
2AA |
2AA |
Concentrations (μg/plate) |
2.5 |
2.5 |
60 |
2.5 |
2.5 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
890 ± 97 |
154 ± 20 |
272 ± 14
|
687 ± 44 |
149 ± 27 |
MNNG = N-methyl-N-nitro-N-nitrosoguanidine
4NQO = 4-nitroquinoline-N-oxide
4NOPD = 4-nitroquinoline-N-oxide
AAC = 9-aminoacridine
2AA = 2-Aminoanthracene
P = Precipitate
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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