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EC number: 250-391-9 | CAS number: 30925-07-6
- 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
Based on the results of a bacterial mutagenicity assay (Ames test), the test item is considered to be non-mutagenic in the absence and presence of metabolic activation (reference 7.6.1 -1).
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:
- 06 September 2016 - 14 November 2016
- 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:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Version / remarks:
- 1993
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 2008
- 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, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9 (pre-treated with Aroclor 1254)
- Test concentrations with justification for top dose:
- Top dose: 5000 µg/plate (maximum recommended concentration)
1st series: 5, 15.8, 50, 158, 500, 1580, 5000 µg/plate (with and without S9 mix)
2nd series: 158, 500, 1580, 2810, 5000 µg/plate (with and without S9 mix)
3rd series: 158, 500, 1580, 2810, 5000 µg/plate (strain TA 1537, with and without S9 mix) - Vehicle / solvent:
- - Solvent used: DMSO
- Justification for choice of solvent: solubitlity properties of the test item, non toxicity to bacteria - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- sodium azide
- other: daunomycin 1 µg/plate (TA 98, + S9), 2-aminoanthracene 2-10 µg/plate (all strains, -S9)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION: exposure 2-3 days
NUMBER OF REPLICATIONS: 3 replicates for test item concentrations and positive controls, 6 replicates for solvent controls
Three experimental series were performed.
DETERMINATION OF CYTOTOXICITY:
- Method: counting numbers of revertants
OTHER:
- S9 concentration: 10% (1st series) and 30% S9 (2nd and 3rd series) - Evaluation criteria:
- Classification as negative or non-mutagenic if:
- the assay was to be considered valid, and
- "no" or "weak increases" occurred in the test series performed ("weak increases" randomly occur due to experimental variation)
Classification as positive or mutagenic if:
- a dose dependent (over at least two test material concentrations) increase in the number of revertants was induced, the maximal effect was a "clear increase" and the effects were reproduced at similar concentration levels in the same test system, or
- "clear increases" occurred at least at one test material concentration, higher concentrations showed strong precipitation or cytotoxicity, and the effects were reproduced at the same concentration level in the same test system. - Statistics:
- Not performed as not mandatory for this test system.
- Key result
- Species / strain:
- S. typhimurium TA 1535
- 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
- Key result
- Species / strain:
- S. typhimurium TA 1537
- 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
- Key result
- Species / strain:
- S. typhimurium TA 98
- 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
- Key result
- Species / strain:
- S. typhimurium TA 100
- 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
- Key result
- 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
- Precipitation: No precipitation occurred.
In the second series there was a high spontaneous rate for TA 1537 observed, that exceeded the tolerance interval of the historical control values. Therefore, it was decided to perform a third series with this strain under the same conditions. In this third series the spontaneous rate was within the tolerance interval of the historical controls thus confirming the validity of the assay. - Conclusions:
- The test item is considered non-mutagenic under the test conditions described.
- Executive summary:
The test item was examined for its mutagenic activity in three series of in vitro microbial assays employing Salmonella typhimurium TA 98, TA 100, TA 1535 and TA 1537, and Escherichia coli WP2 uvrA as indicator organisms. The plate incorporation test with and without addition of liver S9 mix from Aroclor 1254-pre-treated rats was used. In this study, three experimental series were performed. In the experiments with S9 mix, 10 % (1st series) and 30% S9 (2nd and 3rd series) were used.
Treatments of all tester strains were performed using test item formulations prepared in anhydrous analytical grade dimethyl sulfoxide (DMSO) in the absence and in the presence of S9 mix, using final concentrations between 5 and 5000 µg/plate, plus vehicle and positive controls. The strain specific positive control test materials, namely daunomycin, sodium azide, 4-nitroquinolin-N-oxide, and 9-aminoacridine in the absence of S9 mix, yielded the expected mutant frequencies that were greatly in excess of the negative controls. The genotype of the tester strains used was thus confirmed. 2-Aminoanthracene, which requires metabolic activation, was strongly mutagenic. This indicates that the exogenous metabolizing system used in the present investigation (S9 mix) was functioning. Thus, the acceptance criteria have been met in total and the study is considered valid.
Following test item treatments, no precipitation of the test material on the agar plates occurred. There was no toxicity to the bacteria observed.
In the second series there was a high spontaneous rate for TA 1537 observed, that exceeded the tolerance interval of the historical control values. Therefore, it was decided to perform a third series with this strain under the same conditions. In this third series the spontaneous rate was within the tolerance interval of the historical controls thus confirming the validity of the assay.
Under the conditions described, there were no relevant increases in revertant numbers after test item exposure observed in the absence and presence of S9 mix.
According to the criteria for negative and positive results, the test item was not mutagenic under the described experimental conditions.
Reference
Table 2: Summary 1st series
Metabolic Activation |
Test material |
Concentr. (µg/plate) |
Revertant Colony Counts (Mean ± SD) |
||||
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
WP2 uvrA |
|||
Without Activation |
DMSO |
|
37 ± 6 |
93 ± 13 |
31 ± 6 |
36 ± 4 |
25 ± 6 |
Test item |
5 |
34± 7 |
98±3 |
20±5 |
30±2 |
26±5 |
|
15.8 |
38±4 |
107±9 |
24±6 |
29±9 |
26±4 |
||
50 |
34±5 |
117±15 |
24±4 |
27±3 |
30±6 |
||
158 |
39±7 |
98±6 |
27±4 |
34±6 |
28±13 |
||
500 |
48±6 |
117±17 |
23±1 |
31±3 |
28±1 |
||
1580 |
39±7 |
111±9 |
23±8 |
27±8 |
33±13 |
||
5000 |
41±4 |
116± 12 |
27±7 |
32±9 |
32±10 |
||
DAUN |
1 |
364±93 |
|
|
|
|
|
NaN3 |
2 |
|
1197±253 |
781±40 |
|
|
|
9-AA |
50 |
|
|
|
1361±441 |
|
|
NQO |
2 |
|
|
|
|
1499± 224 |
|
With Activation |
DMSO |
|
41±5 |
122±13 |
30±2 |
33±6 |
31±8 |
Test item |
5 | 37± 2 |
138±7 |
24±5 |
31±1 |
37±4 |
|
15.8 |
37±6 |
123±15 |
22±1 |
26±2 |
34±2 |
||
50 |
37±7 |
107±15 |
28±1 |
39±5 |
26±11 |
||
158 |
39±7 |
112±11 |
21±7 |
40±8 |
32±6 |
||
500 |
46±7 |
131±16 |
22±7 |
32±2 |
45±10 |
||
1580 |
39±11 |
113± 14 |
27±3 |
34±6 |
31±3 |
||
5000 |
31±2 |
122±16 |
21±3 |
27±10 |
40±2 |
||
2-AA |
2 |
557± 56 |
1660±111 |
|
|
|
|
2-AA |
5 |
|
|
266±7 |
649±12 |
|
|
2-AA |
10 |
|
|
|
|
769±38 |
Table 3: Summary 2nd series
Metabolic Activation |
Test material |
Concentr. (µg/plate) |
Revertants per plate (Mean ± SD) |
||||
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
WP2 uvrA |
|||
Without Activation |
DMSO |
|
30 ± 8 |
107 ± 11 |
28 ± 4 |
36 ± 8 |
30 ± 5 |
Test item |
158 |
30± 11 |
103± 3 |
34±8 |
34± 5 |
32± 4 |
|
500 |
33± 9 |
102± 5 |
26± 2 |
37± 7 |
27± 4 |
||
1580 |
31± 6 |
106± 5 |
23± 5 |
37± 9 |
29± 2 |
||
2810 |
33± 12 |
110± 16 |
17± 8 |
35±1 |
37± 2 |
||
5000 |
30± 5 |
107± 6 |
26± 3 |
43± 7 |
34± 10 |
||
DAUN |
1 |
255± 32 |
|
|
|
|
|
NaN3 |
2 |
|
977± 91 |
876± 13 |
|
|
|
9-AA |
50 |
|
|
|
1141± 292 |
|
|
NQO |
2 |
|
|
|
|
1309± 31 |
|
With Activation |
DMSO |
|
31± 7 |
125± 16 |
29± 6 |
43± 5 |
35± 8 |
Test item |
158 |
31± 4 |
135± 8 |
28± 8 |
30± 6 |
39± 11 |
|
500 |
33±11 |
126± 13 |
34± 4 |
45± 15 |
37± 9 |
||
1580 |
26±4 |
126± 17 |
30± 8 |
41± 9 |
38± 10 |
||
2810 |
33± 5 |
124± 21 |
24± 6 |
40± 4 |
29± 1 |
||
5000 |
34± 3 |
118± 7 |
22± 2 |
29±6 |
28± 1 |
||
2-AA |
2 |
197± 40 |
|
|
|
|
|
2-AA |
5 |
|
1875± 53 |
|
|
|
|
2-AA |
10 |
|
|
221± 22 |
484± 25 |
171±24 |
Table 4: Summary 3rd series
Metabolic Activation |
Test material |
Concentr. (µg/plate) |
Revertants per plate |
TA 1537 |
|||
Without Activation |
DMSO |
|
33± 8 |
Test item |
158 |
27± 9 |
|
500 |
28± 3 |
||
1580 |
35± 4 |
||
2810 |
30± 7 |
||
5000 |
36± 5 |
||
9-AA |
50 |
1994± 562 |
|
With Activation |
DMSO |
|
35± 8 |
Test item |
158 |
31± 12 |
|
500 |
36± 6 |
||
1580 |
39± 13 |
||
2810 |
35± 2 |
||
5000 |
29± 2 |
||
2-AA |
10 |
257± 40 |
Key to Positive Controls
NaN3 Sodium azide
2-AA 2-Aminoanthracene
9-AA 9-Aminoacridine
DAUN Daunomycin
NQO 4-Nitroquinoline-N-oxide
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
OECD 471, Bacterial Reverse Mutation Assay
The test item was examined for its mutagenic activity in three series of in vitro microbial assays employing Salmonella typhimurium TA 98, TA 100, TA 1535 and TA 1537, and Escherichia coli WP2 uvrA as indicator organisms.The plate incorporation test with and without addition of liver S9 mix from Aroclor 1254-pre-treated rats was used. In this study, three experimental series were performed. In the experiments with S9 mix, 10 % (1stseries) and 30% S9 (2ndand 3rdseries) were used.
Treatments of all tester strains were performed using test item formulations prepared in anhydrous analytical grade dimethyl sulfoxide (DMSO) in the absence and in the presence of S9 mix, using final concentrations between 5 and 5000 µg/plate, plus vehicle and positive controls.The strain specific positive control test materials, namely daunomycin, sodium azide, 4-nitroquinolin-N-oxide, and 9-aminoacridine in the absence of S9 mix, yielded the expected mutant frequencies that were greatly in excess of the negative controls. The genotype of the tester strains used was thus confirmed. 2-Aminoanthracene, which requires metabolic activation, was strongly mutagenic. This indicates that the exogenous metabolizing system used in the present investigation (S9 mix) was functioning. Thus, the acceptance criteria have been met in total and the study is considered valid. Following test item treatments, no precipitation of the test material on the agar plates occurred. There was no toxicity to the bacteria observed.
In the second series there was a high spontaneous rate for TA 1537 observed, that exceeded the tolerance interval of the historical control values. Therefore, it was decided to perform a third series with this strain under the same conditions. In this third series the spontaneous rate was within the tolerance interval of the historical controls thus confirming the validity of the assay. Under the conditions described, there were no relevant increases in revertant numbers after test item exposure observed in the absence andpresence of S9 mix. According to the criteria for negative and positive results, the test item was not mutagenic under the described experimental conditions.
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No 1272/2008
The available experimental data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on genetic toxicity, the test item is not considered to be classified for genetic toxicity (UN GHS: no category) according to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Regulation (EC) No 2017/776.
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