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Diss Factsheets
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EC number: 201-627-4 | CAS number: 85-73-4
- 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)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Phthalylsulfathiazole
- EC Number:
- 201-627-4
- EC Name:
- Phthalylsulfathiazole
- Cas Number:
- 85-73-4
- Molecular formula:
- C17H13N3O5S2
- IUPAC Name:
- 2-({4-[(1,3-thiazol-2-yl)sulfamoyl]phenyl}carbamoyl)benzoic acid
- Details on test material:
- - Name of test material : phthalylsulfathiazole
- Molecular formula : C17H13N3O5S2
- Substance type: Organic
- Physical state: Solid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Age : 10 to 12 weeks
Sex : Female
Body weight range : 1.80kg ±200g
No. of animals : Three
Acclimatization : The rabbit was acclimatized to standard laboratory condition for 24 hours in experimental room before study.
Environmental conditions : Air conditioned room with 10-15 air changes per hour, temperature between 22-250C, relative humidity 40-60% and illumination cycle set to 12 hours artificial fluorescent light and 12 hours dark.
Test system
- Vehicle:
- water
- Amount / concentration applied:
- A dose of 0.1gm of test substance was applied into the one eye of the rabbits. The other eye, which remains untreated, serves as a control
- Duration of treatment / exposure:
- 21 days
- Observation period (in vivo):
- The eyes were examined at 1, 24, 48 and 72 hours after test substance application. The grades of ocular reaction (conjunctiva, cornea and iris) were recorded at each observation. To determine the reversibility of the effect the animal was observed normally for 21 days. Any other lesions in the eye viz pannus, staining were observed and scored accordingly. Examination of reactions was facilitated by use of biomicroscope and hand slit lamp. After recording the observations at 24 hours, the eyes were further examined with the aid of fluorescein. Individual animal weight before and during the study was also observed
- Number of animals or in vitro replicates:
- No. of animals : Three
Results and discussion
In vivo
Results
- Irritation parameter:
- other: MMAS(Modified Maximum Average Draizes Test Score)
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Other effects:
- The test compound phthalylsulfathiazole applied in conjunctival sac of rabbits did not show any observable clinical signs such as cage side activity and pain or stress etc. throughout the observation period of 21 days.
Any other information on results incl. tables
The test compound phthalylsulfathiazole applied to the eye of New Zealand white rabbit at the dose level of 0.1 gm did not produce any clinical signs of eye irritation. Furthermore, any lesions such as pannus, staining were not recorded throughout the observation period
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- phthalylsulfathiazole in non irritating to eye
- Executive summary:
Irritation Scoring
The test compound 85-73-4 applied to the eye of New Zealand white rabbit at the dose level of 0.1 gm produce mild eye discharge and slight redness at 4 hrs of observation. All the signs of irritation were recovered after 24 hours.
Clinical Signs
The test compound 85-73-4 applied in conjunctival sac of rabbits did not show any observable clinical signs throughout the observation period of 21 days.
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