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EC number: 805-289-4 | CAS number: 308065-45-4
- 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
- Study period:
- 8. Dec. 1998 - 19. Jan. 1999
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see "remarks"
- Remarks:
- GLP-Guideline study. According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (Dec 2012)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
- Justification for type of information:
- refer to analogue justification provided in IUCLID section 13
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Safepharm Laboratories Limited, Derby, UK
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 131459-39-7
- Cas Number:
- 131459-39-7
- IUPAC Name:
- 131459-39-7
Constituent 1
Method
- Target gene:
- his operon and trp operon
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: incapable of DNA excision repair (uvrB-); increased permeability of the cell wall (rfa)
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of Sprague-Dawley rats treated with Aroclor 1254
- Test concentrations with justification for top dose:
- 50, 150, 500, 1500, 5000 µg/plate (first and second experiment)
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: acetone
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: without S9: N-ethyl-N'-nitro-N-nitrosoguanidine (ENNG; 3 µg/plate TA100, 5 µg/plate TA1535, 2 µg/plate WP2uvrA-), 9-Aminoacridine (9-AA; 80 µg/plate TA 1535), 4-Nitroquinoline-1 (4NQO; 0.2 µg/plate TA98)
- Positive controls:
- yes
- Positive control substance:
- other: with S9 mix: 2-Aminoanthracene (2AA; 1 µg/plate TA 100, 2 µg/plate TA 1535 and TA 1537, 10 µg/plate WP2uvrA-); Benzo(a)pyrene (BP; 5 µg/plate TA 98)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3 replications each in 2 independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: inspection of bacterial background lawn, number of revertant colonies - Evaluation criteria:
- The test material may be considered to be positive in this test system if the following criteria are met: All tester strain cultures exhibit a characteristic number of spontaneous revertants per plate in the vehicle and untreated controls (see table 1); Each positive control value was at least two times the respective vehicle control value for each strain (for historical values see table 2); A minimum of 4 non-toxic dose levels were achieved; The test material should have induced a reproducible, dose-related and statistically significant increase in the revertant count in at least one strain of bacteria.
- Statistics:
- Dunett's method of linear regression, Kirkland DJ (1989), Statistical Evaluation of Mutagenicity Test Data. UKEMS Sub-comittee on Guidelines for Mutagenicity Testing. Report - Part III - Cambridge University Press
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Remarks:
- oily precipitate at 5000 µg/plate which did not prevent scoring of revertant colonies
- 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, but tested up to precipitating concentrations
- Remarks:
- oily precipitate at 5000 µg/plate which did not prevent scoring of revertant colonies
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: oily precipitate at 5000 µg/plate
RANGE-FINDING/SCREENING STUDIES: the dose range of the test material used in the preliminary toxicity study was 0, 0.15, 0.5, 1.5, 5, 15, 50, 150, 500, 1500, 5000 µg/plate. The test material was non-toxic to the strains of bacteria used (TA100 and WP2uvrA-).
COMPARISON WITH HISTORICAL CONTROL DATA: Values of positive and negative controls were in range of historical control data.
Any other information on results incl. tables
Table 3. Test results of experiment 1 (plate incorporation).
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 |
WP2uvrA- |
TA98 |
TA1537 |
||
– |
0 |
74 ± 9.6 |
21 ± 2.3 |
22 ± 2.0 |
23 ± 4.0 |
8 ± 2.0 |
– |
50 |
75 ± 7.1 |
20 ± 2.1 |
24 ± 2.1 |
24 ± 4.0 |
6 ± 2.0 |
– |
150 |
79 ± 13.1 |
20 ± 6.8 |
22 ± 1.5 |
19 ± 2.6 |
10 ± 1.0 |
– |
500 |
76 ± 4.2 |
15 ± 4.0 |
23 ± 7.0 |
21 ± 4.9 |
9 ± 3.8 |
– |
1500 |
71 ± 6.1 |
20 ± 3.8 |
18 ± 5.5 |
21 ± 5.7 |
10 ± 3.5 |
– |
5000 |
73 ± 1.5 P |
21 ± 5.5 P |
24 ± 6.0 P |
21 ± 5.9 P |
9 ± 2.5 P |
Positive controls, –S9 |
Name |
ENNG |
ENNG |
ENNG |
4NQO |
9AA |
Concentrations (μg/plate) |
3 |
5 |
2 |
0.2 |
80 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
323 ± 11.7 |
283 ± 10.0 |
503 ± 24.2 |
166 ± 5.3 |
1027 ± 358.2 |
|
+ |
0 |
87 ± 1.5 |
16 ± 1.5 |
28 ± 2.3 |
34 ± 6.7 |
18 ± 0.6 |
+ |
50 |
94 ± 6.1 |
13 ± 1.2 |
29 ± 5.8 |
31 ± 0.6 |
23 ± 7.4 |
+ |
150 |
88 ± 4.0 |
13 ± 2.6 |
25 ± 5.6 |
35 ± 6.4 |
19 ± 7.0 |
+ |
500 |
87 ± 3.5 |
12 ± 1.2 |
29 ± 3.8 |
32 ± 9.5 |
20 ± 5.5 |
+ |
1500 |
81 ± 6.5 |
10 ± 0.6 |
30 ± 3.6 |
33 ± 3.8 |
15 ± 4.6 |
+ |
5000 |
77 ± 5.1 P |
12 ± 0.6 P |
30 ± 2.6 P |
31 ± 4.7 P |
18 ± 3.8 P |
Positive controls, +S9 |
Name |
2AA |
2AA |
2AA |
BP |
2AA |
Concentrations (μg/plate) |
1 |
2 |
10 |
5 |
2 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
920 ± 153.0 |
198 ± 9.3 |
555 ± 27.8 |
511 ± 132.0 |
196 ± 6.5 |
ENNG = N-ethyl-N-nitro-N-nitrosoguanidine
4NQO = 4-nitroquinoline-N-oxide
9AA = 9-aminoacridine
2AA = 2 -aminoanthracene
BP = Benzo(a)pyrene
P = Precipitate
Table 4. Test results of experiment 2 (plate incorporation).
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 |
WP2uvrA- |
TA98 |
TA1537 |
||
– |
0 |
103 ± 5.3 |
26 ± 3.8 |
31 ± 8.5 |
29 ± 7.0 |
12 ± 2.9 |
– |
50 |
105 ± 10.8 |
21 ± 4.9 |
30 ± 7.4 |
28 ± 7.1 |
11 ± 1.0 |
– |
150 |
97 ± 7.0 |
26 ± 1.0 |
35 ± 2.9 |
22 ± 1.2 |
13 ± 3.5 |
– |
500 |
104 ± 9.1 |
25 ± 4.6 |
34 ± 5.1 |
26 ± 5.6 |
15 ± 1.7 |
– |
1500 |
110 ± 9.5 |
23 ± 6.0 |
25 ± 0.6 |
27 ± 3.8 |
13 ± 1.7 |
– |
5000 |
112 ± 5.7 P |
28 ± 0.6 P |
35 ± 2.6 P |
20 ± 1.0 P |
11 ± 1.5 P |
Positive controls, –S9 |
Name |
ENNG |
ENNG |
ENNG |
4NQO |
9AA |
Concentrations (μg/plate) |
3 |
5 |
2 |
0.2 |
80 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
880 ± 31.5 |
257 ± 34.4 |
1191 ± 59.3 |
166 ± 4.6 |
1384 ± 263.4 |
|
+ |
0 |
103 ± 8.6 |
13 ± 3.6 |
37 ± 2.1 |
27 ± 6.2 |
20 ± 3.8 |
+ |
50 |
92 ± 21.0 |
12 ± 1.5 |
33 ± 4.0 |
27 ± 7.2 |
20 ± 2.6 |
+ |
150 |
91 ± 7.5 |
14 ± 1.5 |
34 ± 2.6 |
29 ± 4.0 |
22 ± 2.6 |
+ |
500 |
113 ± 15.0 |
14 ± 2.3 |
39 ± 2.1 |
27 ± 6.7 |
15 ± 3.2 |
+ |
1500 |
110 ± 7.6 |
13 ± 2.6 |
36 ± 3.2 |
31 ± 4.9 |
21 ± 3.1 |
+ |
5000 |
97 ± 9.0 P |
17 ± 5.8 P |
30 ± 2.5 P |
28 ± 4.7 P |
22 ± 3.0 P |
Positive controls, +S9 |
Name |
2AA |
2AA |
2AA |
BP |
2AA |
Concentrations (μg/plate) |
1 |
2 |
10 |
5 |
2 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
865 ± 43.2 |
246 ± 7.5 |
1051 ± 90.0 |
611 ± 51.5 |
182 ± 7.0 |
ENNG = N-ethyl-N-nitro-N-nitrosoguanidine
4NQO = 4-nitroquinoline-N-oxide
9AA = 9-aminoacridine
2AA = 2 -aminoanthracene
BP = Benzo(a)pyrene
P = PrecipitateApplicant's summary and conclusion
- Conclusions:
- negative
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