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EC number: 700-422-1 | CAS number: 61320-65-8
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: test method is under evaluation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
Materials and methods
- Principles of method if other than guideline:
- Undissolved diazokomponenten Rot B was applied topically to reconstituted human ocular epithelia (HCE :Human Cornea Epithelial) tissue for 60 min followed by a 16 hour post -treatment incubation period. The potential ocular irritation of the test substance is evaluated by measuring the HCE cell viability using the MTT (Methylthiazoletetrazolium) assay. The HCE model is currently involved in the eye irritation validation conducted by the COLIPA following ECVAM guidelines
- GLP compliance:
- yes
Test material
- Reference substance name:
- methyl 5-amino-4-cyano-3-methylthiophene-2-carboxylate
- EC Number:
- 700-422-1
- Cas Number:
- 61320-65-8
- Molecular formula:
- C8 H8 N2 O2 S
- IUPAC Name:
- methyl 5-amino-4-cyano-3-methylthiophene-2-carboxylate
- Details on test material:
- content 99.1 %
batch No. BOS 2589
Constituent 1
Test animals / tissue source
- Species:
- other: in vitro toest
- Strain:
- other: in vitro test
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: in vitro - assay: --negative control: phosphat buffered saline --positive control 1H-1,2,4 -Triazole-3 -thiol
- Amount / concentration applied:
- 30 mg (RT;three inserts per period of incubation time)
- Duration of treatment / exposure:
- 60 min incubation time
- Observation period (in vivo):
- After the exposure period (RT; three inserts per period of incubation time) the inserts were washed with PBS. After a post-exposure incubation of 16 hours MTT reduction assay was performed
- Number of animals or in vitro replicates:
- not applicable
- Details on study design:
- Undissolved diazokomponenten Rot B was applied topically to reconstituted human ocular epithelia (HCE :Human Cornea Epithelial) tissue for 60 min followed by a 16 hour post -treatment incubation period. The potential ocular irritation of the test substance is evaluated by measuring the HCE cell viability using the MTT (Methylthiazoletetrazolium) assay.
--negative control: phosphat buffered saline (PBS, 30µl)
--positive control 1H-1,2,4 -Triazole-3 -thiol (30 mg, plus 30µlPBS to moisten and ensure good contact with the skin, in three replicates)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: absorption at 570 nm
- Basis:
- other: negative control
- Time point:
- other: 60 min + 16 hours
- Score:
- 1.03
- Max. score:
- 1.16
- Reversibility:
- not specified
- Remarks on result:
- other: Optical Density (OD) 1.03 = 100 % viability;
- Irritation parameter:
- other: absorption at 570 nm
- Basis:
- other: test substance
- Time point:
- other: 60 min + 16 hours
- Score:
- 1.02
- Max. score:
- 1.03
- Reversibility:
- not specified
- Remarks on result:
- other: Optical Density (OD) 1..03 = 100 % viability; OD 1.902 = 99.14 % viability
- Irritation parameter:
- other: absorption at 570 nm
- Basis:
- other: positive control
- Time point:
- other: 60 min + 16 hours
- Score:
- 0.23
- Max. score:
- 1.03
- Reversibility:
- not specified
- Remarks on result:
- other: Optical Density (OD) 1.03 = 100 % viability; OD: 0.23 = 22.63 % viability
- Irritant / corrosive response data:
- Compound Cell viability [%] Evaluation
Diazokomponente Rot B 99.14 non-irritant
Positive control 22.63 irritant
Negative control 100.00 non-irritant
Any other information on results incl. tables
Sample No | Test item | OD mean* | StdDev | % Viability |
1-3 | Negative control PBS | 1.03 | 0.04 | 100.00 |
4-6 | Positive control 1H-1,2,4-Triazole-3-thiol | 0.23 | 0.11 | 22.63 |
7-9 | Diazokomponente Rot B | 1.02 | 0.02 | 99.14 |
* 6 values
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Executive summary:
This in vitro study for assessing ocular irritation of compounds using a human epithelial corneal cell model was performed in 2011. The model used is standardized and commercially available (SkinEthicTM Human Corneal Epithelial Model (HCE); SkinEthic, France).
Undisolved Diazokomponente Rot B was applied topically to the HCE tissue, i.e. 30 mg per insert (three replicates). After an exposure period of 60 minutes, followed by a 16 hours post-treatment incubation period, the cell viability was 99.14% as measured by a MTT conversion assay.
The results of the concurrent negative (NC, PBS) and positive control
(PC, 1H-1,2,4-Triazole-3-thiol) demonstrated the viability (NC) and sensitivity (PC) of the test model.
The results show that Diazokomponente Rot B is predicted as non-irritant under the conditions of this test method (Bayer 2011).
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