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EC number: 257-821-4 | CAS number: 52298-44-9
- 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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test performed before OECD and GLP guidelines. Important aspects are in line with current OECD guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 1975
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: FDA-guideline, Federal Register, Vol. 38, No. 187, 1973
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: company guideline simila to OECD 405
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- prior to GLP implementation
Test material
- Reference substance name:
- 4-amino-2,5-dimethoxy-N-phenylbenzenesulphonamide
- EC Number:
- 257-821-4
- EC Name:
- 4-amino-2,5-dimethoxy-N-phenylbenzenesulphonamide
- Cas Number:
- 52298-44-9
- Molecular formula:
- C14H16N2O4S
- IUPAC Name:
- 4-amino-2,5-dimethoxy-N-phenylbenzene-1-sulfonamide
- Details on test material:
- - Name of test material (as cited in study report): Chinonbasesulfanilid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: SPF-Albino-Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 1.5 - 2.0 kg
- Housing: single cage
- Diet: ERKA 8300, Futterwerke Robert Koch oHG/Hamm, ad libitum
- Water : tap water, ad libitum
ENVIRONMENTAL CONDITIONS: no data
Test system
- Vehicle:
- other: unchanged (no vehicle), or 10% dilution in sesame oil
- Controls:
- other: untreated eye of the test animal
- Amount / concentration applied:
- a) 100 mg unchanged substance without vehicle
b) 0.1 ml of a 10% dilution of the substance in sesame oil - Duration of treatment / exposure:
- Duration of treatment was 24 h. Eyes were rinsed with phsiol. saline after the first examination (24 after instillation).
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 6 for the unchanged (no vehicle) substance and 6 for the 10% dilution
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing : physiologic NaCl-solution
- Time after start of exposure: 24 h (= after the first examination)
TOOL USED TO ASSESS SCORE: hand-slit lamp / binocular / fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: # 50, 21, 72, 20, 78, 51 each
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no signs of irritation (cornea) at any time
- Remarks on result:
- other: unchanged (no vehicle)
- Irritation parameter:
- iris score
- Basis:
- animal: # 50, 21, 72, 20, 78, 51 each
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no signs of irritation (iris) at any time
- Remarks on result:
- other: unchanged (no vehicle)
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: # 51
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: unchanged (no vehicle)
- Irritation parameter:
- conjunctivae score
- Basis:
- other: # 50,72, 78 each
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- other: unchanged (no vehicle)
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: # 21, 20 each
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- other: unchanged (no vehicle)
- Irritation parameter:
- chemosis score
- Basis:
- animal: # 50, 21, 72, 20, 78, 51 each
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no signs of irritation (chemosis) at any time
- Remarks on result:
- other: unchanged (no vehicle)
- Irritant / corrosive response data:
- All mean scores calculated for the 10% dilution are 0
- Other effects:
- No other effects reported.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- Based on the findings in this test the unchanged test substance and its 10% dilution are not eye-irritating.
- Executive summary:
Chinonbasesulfanilid was tested for eye irritating properties according to FDA-guideline (Federal Register, Vol. 38, No. 187, 1973) which is similar to OECD 405. Following this protocol 100 mg of the undiluted test substance (or a 10% dilution) were applied into the conjunctival sac of one eye from each of six rabbits. The other eye remained untreted and served as control. After 24 h exposure time the eyes were rinsed with physiol. saline. The eyes of the animals were examined at 1, 7, 24, 48, 72 h, and 7, 14 days after test substance application. Mean scores (mean of 24, 48, 72 h) were calculated for cornea, iris, conjunctivae redness, and conjunctivae chemosis for each animal.
Based on the findings in this test the unchanged test substance and its 10% dilution are not eye-irritating.
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