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EC number: 940-673-6 | CAS number: 1391764-61-6
- 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
- Study period:
- November to December 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to OECD guideline under GLP
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Deviations:
- no
- Principles of method if other than guideline:
- Not relevant
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- K-36
- IUPAC Name:
- K-36
- Reference substance name:
- N,N-dibutyl-4-[4-(4-chlorophenyl)-3,6-dioxo-2H,3H,5H,6H-pyrrolo[3,4-c]pyrrol-1-yl]benzamide
- Cas Number:
- 1391764-61-6
- Molecular formula:
- C27H28ClN3O3
- IUPAC Name:
- N,N-dibutyl-4-[4-(4-chlorophenyl)-3,6-dioxo-2H,3H,5H,6H-pyrrolo[3,4-c]pyrrol-1-yl]benzamide
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- other: Bos primigenius Taurus (Fresh bovine corneas)
- Details on test animals or tissues and environmental conditions:
- Fresh bovine corneas were held at 32 °C.
Test system
- Vehicle:
- other: olive oil
- Amount / concentration applied:
- 750 μL of the test item suspension (concentration 20% in olive oil) were applied.
- Duration of treatment / exposure:
- Exposition time on the corneas was 4 h ± 5 min. at 32 °C.
- Observation period (in vivo):
- 4 h ± 5 min.
- Details on study design:
- SCORING SYSTEM: IVIS (in vitro irritancy score)
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Results
- Irritation parameter:
- other: IVIS (in vitro irritancy score)
- Basis:
- mean
- Time point:
- other: 4
- Score:
- -0.182
- Irritant / corrosive response data:
- Physiological sodium chloride solution was used as negative control and olive oil was used as solvent control. The negative control and the solvent
control showed no irritating effect on the cornea and induced no serious eye damage.
20% Imidazole solution was used as positive control. The positive control induced serious eye damage on the cornea.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- The test item K-36 showed no irritating effects or serious eye damage on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score)
is -0.182. According to OECD Guideline no. 437 (Jul. 2013), a substance with an IVIS ≤ 3 requires no classification for eye irritation or serious eye
damage. - Executive summary:
This “in vitro” study was performed to assess the corneal damage potential of K-36 by quantitative measurements of changes in opacity and permeability in a bovine cornea. The study was performed for regulatory purposes.
One valid experiment was performed.
Bovine corneas were used. They were collected from slaughtered cattle which were between 12 and 60 months old.
The test item K-36 was brought onto the cornea of a bovine eye which had been incubated with cMEM without phenol red at 32 ± 1 °C for one hour and whose opacity had been measured. The test item was incubated on the cornea for 4 hours at 32 ± 1 °C. After removal of the test item, opacity and permeability values were measured.
Physiological sodium chloride solution was used as negative control and olive oil was used as solvent control. The negative control and the solvent control showed no irritating effect on the cornea and induced no serious eye damage.
20% Imidazole solution was used as positive control. The positive control induced serious eye damage on the cornea.
The test item K-36 showed no irritating effects or serious eye damage on the cornea of the
bovine eye. The calculated IVIS (in vitro irritancy score) is -0.182.
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