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EC number: 602-997-3 | CAS number: 124495-18-7
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 84-2
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reference substance 001
- Cas Number:
- 124495-18-7
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- - Substance ID: TSN 100097
- Name of substance: XDE-795
- Lot number: DECO-97-152-1
- Purity: 97.4%
Method
- Target gene:
- histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 mix prepared from Aroclor 1254-induced Sprague-Dawley rats
- Test concentrations with justification for top dose:
- Range finding assay: 5.0, 10, 50, 100, 500, 1000, 5000 µg/plate for both with and without S9 activation
Mutation assay and confirmatory mutation assay: 10, 50, 100, 500, 1000 µg/plate and 50, 100, 500, 1000, 5000 µg/plate with and without S9 activation, respectively - Vehicle / solvent:
- Dimethyl sulfoxide
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: 2-Aminoanthracene (TA98, TA100, TA1535, TA1537 with S9)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar
- Cell density at seeding: 5.0 x 10e7 to 1.0 x 10e8
DURATION
- Incubation temperature: 37 ± 1°C
- Incubation period: 20 minutes before inverting the plates and 68 hours after inverting the plates
NUMBER OF REPLICATIONS: Single
COLONY COUNTING: Hand counting was done for the plates where precipitate was formed. Remaining plates were counted using automatic colony counter.
NUMBER OF CELLS EVALUATED: 0.912 x 10e8 - Evaluation criteria:
- A response is considered negative if: all of the strains treated with test substance have mean reversion frequencies that are less than three times that of the mean reversion frequencies of the corresponding solvent control plates; and there is no evidence of a dose-dependent response.
A response is considered positive if two or more doses produce a mean reversion frequency that is three times or more greater than the mean reversion frequencies of the corresponding solvent control plates and the response is reproducible.
A response is considered equivocal if it does not fulfill the criteria of either a negative or a positive response and/or the Study Director does not consider the response to be either positive or negative.
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium, other: TA1535, TA1537, TA100, TA98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING STUDIES: In the range finding test the test substance was evaluated at concentrations ranging from 5000 to 5.0 µg/plate in both the absence and presence of exogenous activation. The test substance concentrations of 1000 µg/plate and above produced a significant degree of toxicity in the absence of S-9 activation. The relative cloning efficiency (RCE) was 71% and 0%. The background lawn also was significantly reduced. There were not any revertants observed at the concentration of 5000 µg/plate. A moderate toxicity was observed at concentrations of 1000 µg/plate and above in the presence of S-9 activation. The toxicity was manifested only as a reduction in the number of viable colonies per plate. The relative cloning efficiency was 78% and 72%.
Based on these results, it was decided to perform the mutation assay at test substance concentrations of 1000, 500, 100, 50 and 10 µg/plate and 5000, 1000, 500, 100 and 50 µg/plate in the absence and presence of S-9, respectively.
Any other information on results incl. tables
Table-1: Initial (trial 1) and confirmatory (trial 2) mutation assays results - without metabolic activation
Compound |
Conc. |
TA98 |
TA100 |
TA1535 |
TA1537 |
||||
Trial |
Trial |
Trial |
Trial |
Trial |
Trial |
Trial |
Trial |
||
Test substance |
1000 |
22 |
22 |
81 |
87 |
23 |
20 |
11 |
12 |
500 |
20 |
19 |
103 |
93 |
19 |
22 |
11 |
10 |
|
100 |
30 |
29 |
100 |
92 |
26 |
26 |
17 |
16 |
|
50 |
24 |
26 |
108 |
93 |
28 |
28 |
17 |
17 |
|
10 |
28 |
27 |
101 |
90 |
28 |
28 |
17 |
19 |
|
Solvent control |
_ |
30 |
31 |
109 |
91 |
30 |
30 |
18 |
19 |
Positive control |
_ |
903 |
901 |
587 |
618 |
529 |
535 |
209 |
210 |
Table-2: Initial (trial 1) and confirmatory (trial 2) mutation assays results - with metabolic activation
Compound |
Conc. |
TA98 |
TA100 |
TA1535 |
TA1537 |
||||
Trial |
Trial |
Trial |
Trial |
Trial |
Trial |
Trial |
Trial |
||
Test substance |
5000 |
32 |
36 |
142 |
84 |
14 |
15 |
10 |
13 |
1000 |
38 |
34 |
145 |
112 |
17 |
18 |
16 |
16 |
|
500 |
37 |
27 |
129 |
109 |
22 |
24 |
22 |
23 |
|
100 |
41 |
36 |
143 |
106 |
21 |
23 |
21 |
21 |
|
50 |
39 |
41 |
123 |
106 |
23 |
22 |
22 |
22 |
|
Solvent control |
_ |
39 |
41 |
124 |
98 |
25 |
23 |
23 |
23 |
Positive control |
_ |
1994 |
1999 |
1775 |
1734 |
156 |
147 |
217 |
221 |
Applicant's summary and conclusion
- Conclusions:
- Negative with and without the metabolic activation in S. typhimurium strains
- Executive summary:
The test substance was evaluated for its potential to cause mutations at the histidine operon of Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537. The study was conducted following FIFRA guideline 84-2. The test substance was evaluated for toxicity to strain TA100 in the range finding test. Tester strain TA100 was exposed to the test substance in the absence of exogenous activation and in the presence of Aroclor 1254-induced rat liver S-9 plus cofactors. The toxicity was evaluated based on 1) reversion frequency, 2) viability, and 3) integrity of the background lawn. The test substance was evaluated at concentrations ranging from 5000 to 5.0 µg/plate in both the absence and presence of exogenous activation. The results of the range finding test indicated that the test substance produced a significant degree of toxicity at concentrations of 1000 µg/plate and above in the absence of S-9 activation. A moderate toxicity at concentrations of 1000 µg/plate and above was observed in the presence of S-9 activation.
The initial mutation assay was performed using concentrations of 1000, 500, 100, 50 and 10 µg/plate and 5000, 1000, 500, 100, and 50 µg/plate in the absence and presence of S-9, respectively. The same concentrations were used in the confirmatory mutation assay to confirm the results of the initial mutation assay. The results of both mutation assays indicated that the test substance did not induce any positive increase in the number of revertant colonies for any of the tester strains in the absence and presence of Aroclor 1254-induced rat liver S-9.
Under the conditions of this study, the test substance was negative in the Salmonella typhimurium preincubation mutation assay.
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