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EC number: 429-460-4 | CAS number: 7078-98-0
- 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: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Substituted Quinone Methide
- IUPAC Name:
- Substituted Quinone Methide
- Details on test material:
- Batch: PR-001 GDF97053
Physical description: amber solid.
Storage: Room temperature
Constituent 1
Method
- Target gene:
- Histidine for Salmonella typhimurium
Tryptophan for E.Coli.
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- Not applicable.
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- Not applicable.
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor induced rat livers (S9 fraction)
- Test concentrations with justification for top dose:
- Rangefinding test:
6.67 - 5000 μg/plate
Concentration range in main test:
With metabolic activation: 10 - 5000 μg/plate (10.0, 33.3, 100, 333, 1000, 5000 μg/plate)
Without metabolic activation: 10 - 5000 μg/plate (10.0, 33.3, 100, 333, 1000, 5000 μg/plate) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: See remarks.
- Remarks:
- Used with S9 mix: benzo(a)pyrene, 2-aminoanthracene. Used without S9 mix: 2-nitrofluorene, sodium azide, ICR-191, 4-nitroquinoline-N-oxide.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: overnight.
- Exposure duration: 52 hrs (+/- 4 hrs)
- Expression time (cells in growth medium): Not applicable
- Selection time (if incubation with a selection agent): Not applicable
- Fixation time (start of exposure up to fixation or harvest of cells): 52 hrs (+/- 4 hrs)
SELECTION AGENT (mutation assays): Not applicable.
NUMBER OF REPLICATIONS: Triplicate plating.
NUMBER OF CELLS EVALUATED: Not applicable.
DETERMINATION OF CYTOTOXICITY
- Method:
Bacterial Background Lawn Evaluation -
The condition of the bacterial background lawn was evaluated for evidence of cytotoxicity and test article precipitate. Evidence of cytotoxicity was scored relative to the vehicle control plate and was recorded along with the revertant counts for all plates at that dose level.
Counting revertant colonies -
The number of revertant colonies per plate for the vehicle controls and all plates containing test article were counted manually. The number of revertant colonies per plate for the positive controls were counted by automated colony counter.
OTHER EXAMINATIONS: None - Evaluation criteria:
- Criteria For A Positive Response:
Once the criteria for a valid assay had been met, responses observed in the assay were evaluated as follows:
1. Tester Strains TA98, TA100 and WP2uvrA
For a test article to be considered positive, it had to produce at least a 2-fold increase in the mean revertants per plate of at least one of these tester strains over the mean revertants per plate of the appropriate vehicle control. This increase in the mean number of revertants per plate had to be accompanied by a dose response to increasing concentrations of the test article.
2. Tester Strains TA1535 and TA1537
For a test article to be considered positive, it had to produce at least a 3-fold increase in the mean revertants per plate of at least one of these tester strains over the mean revertants per plate of the appropriate vehicle control. This increase in the mean number of revertants per plate had to be accompanied by a dose response to increasing concentrations of the test article.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- 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 nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- 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 nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: precipitation seen at dose level of 1000 μg/plate and above.
RANGE-FINDING/SCREENING STUDIES:
No cytotoxicity was observed in either the presence or absence of S9 mix as evidenced by no decrease in the number of revertants per
plate. The bacterial background lawns were evaluated as normal up to the 1,000 μg per plate dose. Lawns above this dose were obscured by precipitate.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
The test substance did not cause a positive increase in the number of revertants per plate of any of the tester strains either in the presence or absense of microsomal enzymes prepared from Aroclor 1254 induced rat liver (S9). - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
The test substance did not cause a positive increase in the number of revertants per plate of any of the tester strains either in the presence or absence of microsomal enzymes prepared from Aroclor 1254 induced rat liver (S9) microsomal fraction. The positive controls demonstrated the sensitivity of the test and the negative controls were within historical limits.
Metabolic activation |
Test Substance Concentration (μg/plate) Resulting in: |
|||
Cytotoxicity in Preliminary Test |
Cytotoxicity in Main Test |
Precipiatation |
Genotoxic Effect |
|
Present |
|
|
|
|
Test 1 |
>5000 |
>5000 |
1000 |
- |
Test 2 |
>5000 |
>5000 |
1000 |
- |
Absent |
|
|
|
|
Test 1 |
>5000 |
>5000 |
1000 |
- |
Test 2 |
>5000 |
>5000 |
1000 |
- |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The notified chemical was not mutagenic to bacteria under the conditions of the test. - Executive summary:
Introduction:
The test substances mutagenic activity was investigated in a Salmonella - Escherichia coli/Mammalian-Microsome Reverse Mutation Assay with a Confirmatory Assay. This assay evaluated the test article and/or its metabolites for their ability to induce reverse mutations at the histidine locus in the genome of specific Salmonella typhimurium tester strains and at the tryptophan locus in an Escherichia coli tester strain, both in the presence and absence of an exogenous metabolic activation system of mammalian microsomal enzymes derived from Aroclor-induced rat liver (S9).
Method:
The doses tested in the mutagenicity assay were selected based on the results of a dose range finding study using tester strains TA100 and WP2uvrA and ten doses of test article ranging from 5,000 to 6.67 μg per plate, one plate per dose, both in the presence and absence of S9 mix. The tester strains used in the mutagenicity assay were Salmonella typhimurium tester strains TA98, TA100, TA1 535, TA1537, and Escherichia coli tester strain WP2MvrA. The assay was conducted with six doses of test article in both the presence and absence of S9 mix along with concurrent vehicle and positive controls using three plates per dose. The doses tested were 5,000, 1,000, 333, 100, 33.3, and 10.0 μg per plate in both the presence and absence of S9 mix. The results of the initial mutagenicity assay were confirmed in an independent experiment. Conclusions:The test substance did not cause a positive increase in the number of revertants per plate of any of the tester strains either in the presence or absence of microsomal enzymes prepared from Aroclor 1254 induced rat liver (S9)
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