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EC number: 938-829-3 | CAS number: 936103-10-5
- 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:
- From 6 October 2014 to 18 December 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well described study performed according to OECD guideline and GLP
- 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
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- not specified
- 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
- Metabolic activation:
- with and without
- Metabolic activation system:
- post mitochondrial supernatant prepared from the livers of phenobarbital/b-naphthoflavone-induced rats.
- Test concentrations with justification for top dose:
- 5000, 2500, 1250, 625, 312.5, 156.25, 78.13 and 39.06 μg/plate.
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMF (N,N-Dimethylformamide)
- Justification for choice of solvent/vehicle: based on the results of a solubility test - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-1,2-phenylenediamine (NPD), 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation) for the initial test; preincubation in the confirmatory test
DURATION
- Preincubation period: 20 minutes (confirmatory tests)
- Exposure duration: 48±1 hours
NUMBER OF REPLICATES: 3 per dose level
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - Evaluation criteria:
- Criteria for a Positive Response:
The test item was considered to have shown mutagenic activity in this study if a 2-fold increase (in S. typhimurium TA98, TA100 and E. coli WP2 uvrA strains) or 3-fold increase (in S. typhimurium TA1535 and TA1537 strains) in the mean number of revertants was observed when compared to the vehicle (solvent) controls, in any strain, with an evidence of a dose-response relationship.
Criteria for a Negative Response:
The test item was considered to have shown no mutagenic activity in this study if no increase in the mean number of revertants, reaching 2-fold (for S. typhimurium TA98, TA100 and E. coli WP2 uvrA strains) or 3-fold (for S. TA1535 and TA1537 strains) of the vehicle controls value, was observed at any of the tested dose-levels.
Reference to historical data or other considerations of biological relevance might be taken into account in the evaluation of the data obtained.
Statistical method may be used as an aid in evaluating the test results. - Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- see details below
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
No insolubility was detected in the main tests in any examined bacterial strains with and without metabolic activation.
RANGE-FINDING/SCREENING STUDIES:
In the Preliminary Range Finding Test, substantial increases of the revertant counts were observed in Salmonella typhimurium TA98 bacterial strain with and without metabolic activation. The calculated mutation factor values were over the relevant threshold value in this strain in several cases, dose dependence was also observed.
No precipitate was detected on the plates in the preliminary experiment in Salmonella typhimurium TA98 bacterial strain with and without metabolic activation.
No signs of inhibitory, cytotoxic effects were observed in the preliminary experiment in Salmonella typhimurium TA98 bacterial strain at any concentrations with or without metabolic activation.
COMPARISON WITH HISTORICAL CONTROL DATA:
The mean values of revertant colony numbers of untreated, negative (vehicle/solvent) and positive control plates were in harmony with the historical control range in all strains.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
Inhibitory, cytotoxic effect of the test item (slightly reduced background lawn development, reduced number of revertant colonies was also detected in some cases) was observed in the Confirmatory Mutation Test in Salmonella typhimurium TA1537 strain at 5000 μg/plate concentration with and without metabolic activation. - Conclusions:
- Interpretation of results (migrated information):
positive without and without metabolic activation (in S. typhimurium TA 98)
negative all other strains with and without metabolic activation
R0056895A had mutagenic activity in Salmonella typhimurium TA98 strain in the presence and absence of metabolic activation system. However, no mutagenic activity of the test item was observed in the other four experimental strains under the test conditions of this study. Based on these data, the overall result is positive. - Executive summary:
R005895A was tested for potential mutagenic activity using the Bacterial Reverse Mutation Assay, based on OECD Guidelines for Testing of Chemicals, No.471 and Commission Regulation (EC) No. 440/2008, B.13/14. with Salmonella typhimurium TA98, TA100, TA1535 and TA1537 and Escherichia coli WP2 uvrA, in the presence and absence of a post mitochondrial supernatant (S9 fraction) prepared from the livers of phenobarbital/b-naphthoflavone-induced rats. R0058407A was tested up to 5000 µg/plate in DMF.
R0056895A had mutagenic activity in Salmonella typhimurium TA98 strain in the presence and absence of metabolic activation system. However, no mutagenic activity of the test item was observed in the other four experimental strains under the test conditions of this study.
Based on these data, the overall result is positive.
Reference
Table 1: Summary Table of the Initial Mutation Test (Mean values of revertants)
Concentrations
|
Salmonella typhimuriumstrains |
Escherichia coli |
|||||||||
TA98 |
TA100 |
TA1535 |
TA1537 |
WP2uvrA |
|||||||
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
||
Untreated control |
24.0 |
25.7 |
107.7 |
108.0 |
11.7 |
11.7 |
10.7 |
11.3 |
77.3 |
66.3 |
|
Distilled water control |
- |
- |
87.3 |
- |
13.0 |
- |
- |
- |
78.0 |
- |
|
DMSO |
21.3 |
35.7 |
- |
97.3 |
- |
9.7 |
14.7 |
11.3 |
- |
68.0 |
|
DMF |
17.3 |
28.3 |
81.7 |
94.0 |
15.0 |
10.7 |
14.0 |
10.3 |
85.0 |
66.7 |
|
5000 |
486.7 |
510.7 |
116.3 |
108.0 |
9.0 |
9.3 |
16.7 |
12.0 |
55.3 |
71.3 |
|
2500 |
313.3 |
348.0 |
104.3 |
100.3 |
11.7 |
9.3 |
13.7 |
11.3 |
63.7 |
61.7 |
|
1250 |
207.3 |
221.3 |
105.3 |
109.0 |
15.7 |
7.0 |
16.3 |
16.0 |
73.3 |
73.7 |
|
625 |
126.7 |
133.3 |
102.0 |
103.0 |
18.3 |
13.0 |
15.3 |
15.0 |
76.0 |
71.7 |
|
312.5 |
64.3 |
96.3 |
83.7 |
103.3 |
15.7 |
12.0 |
16.0 |
15.3 |
66.0 |
67.7 |
|
156.25 |
47.0 |
56.3 |
92.7 |
105.3 |
14.3 |
11.3 |
15.3 |
12.3 |
74.7 |
69.3 |
|
78.13 |
26.3 |
43.0 |
85.0 |
98.7 |
13.3 |
12.3 |
13.0 |
15.0 |
78.0 |
71.7 |
|
39.06 |
23.7 |
40.3 |
93.0 |
85.3 |
16.0 |
12.0 |
10.0 |
10.7 |
110.0 |
77.3 |
|
NPD (4µg) |
392.0 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
|
2AA (2µg) |
- |
2521.3 |
- |
2393.3 |
- |
190.3 |
- |
196.7 |
- |
- |
|
2AA (50µg) |
- |
- |
- |
- |
- |
- |
- |
- |
- |
309.7 |
|
SAZ (2µg) |
- |
- |
1093.3 |
- |
1084.0 |
- |
- |
- |
- |
- |
|
9AA (50µg) |
- |
- |
- |
- |
- |
- |
390.7 |
- |
- |
- |
|
MMS (2µL) |
- |
- |
- |
- |
- |
- |
- |
- |
1121.3 |
- |
Table 2: Summary Table of the Confirmatory Mutation Test (Mean values of revertants)
Concentrations
|
Salmonella typhimuriumstrains |
Escherichia coli |
|||||||||
TA98 |
TA100 |
TA1535 |
TA1537 |
WP2uvrA |
|||||||
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
||
Untreated control |
17.0 |
26.0 |
100.3 |
104.0 |
12.0 |
7.3 |
4.0 |
11.7 |
30.7 |
41.7 |
|
Distilled water control |
- |
- |
98.0 |
- |
14.0 |
- |
- |
- |
31.3 |
- |
|
DMSO |
21.0 |
27.3 |
- |
94.3 |
- |
11.0 |
3.7 |
7.0 |
- |
31.7 |
|
DMF |
24.3 |
32.7 |
91.0 |
100.0 |
18.7 |
9.0 |
6.3 |
7.0 |
27.0 |
32.7 |
|
5000 |
488.0 |
341.3 |
102.3 |
116.0 |
8.7 |
10.3 |
4.7 |
0.3 |
28.7 |
29.7 |
|
2500 |
774.7 |
335.3 |
106.3 |
104.3 |
11.0 |
11.7 |
9.3 |
4.3 |
38.7 |
43.0 |
|
1250 |
214.7 |
272.0 |
88.3 |
99.7 |
12.0 |
11.0 |
7.7 |
14.3 |
49.3 |
52.7 |
|
625 |
157.0 |
183.7 |
103.7 |
97.3 |
15.0 |
9.7 |
9.7 |
12.7 |
48.0 |
59.3 |
|
312.5 |
89.7 |
104.3 |
101.3 |
111.3 |
17.3 |
7.7 |
7.7 |
8.7 |
51.0 |
58.7 |
|
156.25 |
52.7 |
71.7 |
103.3 |
105.7 |
12.3 |
11.0 |
7.0 |
7.0 |
52.3 |
56.3 |
|
78.13 |
34.3 |
47.0 |
93.3 |
100.3 |
19.0 |
9.3 |
8.0 |
9.7 |
53.0 |
60.7 |
|
39.06 |
29.7 |
48.7 |
105.0 |
108.3 |
12.7 |
8.0 |
10.7 |
9.7 |
44.0 |
44.7 |
|
NPD (4µg) |
362.3 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
|
2AA (2µg) |
- |
2328.0 |
- |
2406.7 |
- |
315.7 |
- |
193.3 |
- |
- |
|
2AA (50µg) |
- |
- |
- |
- |
- |
- |
- |
- |
- |
247.7 |
|
SAZ (2µg) |
- |
- |
1194.7 |
- |
1198.7 |
- |
- |
- |
- |
- |
|
9AA (50µg) |
- |
- |
- |
- |
- |
- |
385.3 |
- |
- |
- |
|
MMS (2µL) |
- |
- |
- |
- |
- |
- |
- |
- |
896.0 |
- |
Endpoint conclusion
- Endpoint conclusion:
- no study available (further information necessary)
Additional information
R005895A was tested for potential mutagenic activity using the Bacterial Reverse Mutation Assay, based on OECD Guidelines for Testing of Chemicals, No.471 and Commission Regulation (EC) No. 440/2008, B.13/14. with Salmonella typhimurium TA98, TA100, TA1535 and TA1537 and Escherichia coli WP2 uvrA, in the presence and absence of a post mitochondrial supernatant (S9 fraction) prepared from the livers of phenobarbital/b-naphthoflavone-induced rats. R0058407A was tested up to 5000 µg/plate in DMF.
R0056895A had mutagenic activity in Salmonella typhimurium TA98 strain in the presence and absence of metabolic activation system. However, no mutagenic activity of the test item was observed in the other four experimental strains under the test conditions of this study.
Based on these data, the overall result is positive.
Justification for selection of genetic toxicity endpoint
Only one study, well described and performed according to OECD guideline and GLP
Justification for classification or non-classification
A positive result was observed in one strain of S. typhimurium in the Ames' test. However, this result is insufficient for classification. Additional information as in-vitro mammalian assays could be useful for classification purpose.
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