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Diss Factsheets
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EC number: 810-021-4 | CAS number: 111304-31-5
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study has been performed in accordance with OECD guideline No.:405.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- methyl (2Z)-2-(2-nitrobenzylidene)-3-oxobutanoate
- EC Number:
- 810-021-4
- Cas Number:
- 111304-31-5
- Molecular formula:
- C12H11NO5
- IUPAC Name:
- methyl (2Z)-2-(2-nitrobenzylidene)-3-oxobutanoate
- Test material form:
- solid: crystalline
- Details on test material:
- Name: Niliden
Cas no.: 111304-31-5
Batch no.: ND-78
Date of analysis: October 2014
Re-test date: October 2015
Storage: In the refrigerator (2-8°C)
Description: a white to pale yellow crystalline substance
Purity by HPLC: 99,6%
pH value: 5-6
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Number of animals: 1 male
Age of animals: adult rabbit, 11 weeks old
Body weight at the beginning of the study: 2786 g
Body weight at the end of the study: 3216 g
Housing: Animal was housed individually in metal cage
Light: 12 hours daily, from 6:00 a.m. to 6:00 p.m.
Temperature: 20±3 °C
Relative humidity: 30-70 %
Ventilation: 10-15 air exchanges / hour by central air-conditioning system
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0,1 g of test item was used for the study in undiluted form.
- Duration of treatment / exposure:
- The test item was instilled into the conjunctival sac of the left eye of animal. The eye of the test animal was not washed out 24 hour after test item application.
- Observation period (in vivo):
- The eyes were examined at 1, 24, 48, 72 hours after the application. The duration of the observation period was sufficient for the statement of reversibility or irreversibility.
- Number of animals or in vitro replicates:
- 1
- Details on study design:
- The acute eye irritation study with test item Niliden was performed in a New Zealand White rabbit. The initial test was performed only; because of severe conjunctival irritation sign occured 24 hours after the treatment.
Results and discussion
In vivo
Results
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24,48,72
- Score:
- 4
- Reversibility:
- fully reversible within: 2 weeks
- Irritant / corrosive response data:
- 1 hour after the single application of test item into the eye of the rabbit, moderate redness, moderate to severe chemosis and severe discharge occured.
24 hours after treatment severe chemosis and discharge were recorded. Redness of conjunctivae, corneal and iris alterations could not be observed due to the swelling the lids were completely closed.
1 week after treatment slight redness, slight to moderate chemosis and slight discharge were recorded.
2 weeks after the treatment animal was free of symptoms, so the study was finished.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to Regulation (EC) No. 1272/2008, the test item should be classified into "Category 2 (reversible effects on the eye/irritating to eyes)" on the basis of conjunctivae irritation sign as chemosis.
However, it is to be noted that the test item caused severe conjunctivae irritation sign as chemosis in 24, 48 and 72 hours after the treatment, so the redness, cornea opacity and iris irritation could not be scored.
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