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Diss Factsheets
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EC number: 268-697-6 | CAS number: 68133-69-7
- 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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
- Principles of method if other than guideline:
- According to The Code of Federal regulations, title 16, section 1500.42.
- GLP compliance:
- no
Test material
- Reference substance name:
- Disperse Red 177
- IUPAC Name:
- Disperse Red 177
Constituent 1
Test animals / tissue source
- Species:
- rabbit
Test system
- Vehicle:
- physiological saline
- Controls:
- yes
- Amount / concentration applied:
- 59 mg
- Observation period (in vivo):
- 24, 48, 72 h and 7 d
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- Ocular reactions were scored by the method described by J-H. Draize in "Appraisal of the safety of chemicals in foods, drugs and cosmetics" p51, 1959.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1 and #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible within: 3 d
- Irritation parameter:
- chemosis score
- Basis:
- animal: #4 and #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 d
- Irritant / corrosive response data:
- Temporary corneal opacities developed in three animals and a temporary dulling of the normal lustre of the cornea was observed in one other animal. A small ulcerated area was observed on the cornea of the latter. This had resolved by day 7.
A diffuse crimson-red colouration of the coniunctivae accompanied by slight to considerable swelling with partial eversion of the eyelids or with the eyes about half closed was observed in four animals. Some slight haemorrhagic lesions were observed in the coniunctivae of animal number 6 on day 3.
Mild conjunctival reactions were seen in the two remaining animals.
Any other information on results incl. tables
Numerical scores associated to ocular reactions
animal no. | region of eye | day | |||
1 | 2 | 3 | 7 | ||
1 | cornea | 0 | D | D | 0 |
iris | 0 | 0 | 0 | 0 | |
conjunctivae redness | 2 | 2 | 2 | 1 | |
conjunctivae chemosis | 3 | 2 | 2 | 1 | |
2 | cornea | 0 | 0 | 0 | 0 |
iris | 0 | 0 | 0 | 0 | |
conjunctivae redness | 1 | 2 | 1 | 1 | |
conjunctivae chemosis | 2 | 2 | 1 | 0 | |
3 | cornea | 1 | D | 0 | 0 |
iris | 0 | 0 | 0 | 0 | |
conjunctivae redness | 1 | 1 | 1 | 0 | |
conjunctivae chemosis | 1 | 1 | 0 | 0 | |
4 | cornea | D | 1 | D | 0 |
iris | 0 | 0 | 0 | 0 | |
conjunctivae redness | 1 | 0 | 0 | 0 | |
conjunctivae chemosis | 1 | 1 | 1 | 0 | |
5 | cornea | D | 1 | D | 0 |
iris | 0 | 0 | 0 | 0 | |
conjunctivae redness | 1 | 1 | 2 | 0 | |
conjunctivae chemosis | 1 | 1 | 1 | 0 | |
6 | cornea | 0 | 0 | 0 | 0 |
iris | 0 | 0 | 0 | 0 | |
conjunctivae redness | 2 | 2 | 2 | 1 | |
conjunctivae chemosis | 2 | 2 | 1 | 1 |
D = dulling of the cornea
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritant according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- Not irritant to rabbit eye.
- Executive summary:
Method
Study conducted according to The Code of Federal Regulations, title 16, section 1500.42. Accordingly, 59 mg of test substance was instilled into one eye of 6 rabbits, while the untreated eye remained as control. Ocular reactions on cornea, iris and conjunctivae were scored according to Draize, after 24, 48, 72 h and 7 d. No rinse was done.
Results
No effects on iris were noted; cornea opacity and dulling was noted in 5/6 rabbits and such effect was fully reversible within 7 days.
Conjunctivae redness and chemosis were noted in 6/6 rabbits and scored less than 2 over the 24/48/72 h observation period, except for 2/6 and 1/6 rabbits, respectively. Even in case such effect did not disappear by the end of the observation period (7 days), a clear tendency to decrease was evident.
On these bases, test substance was considered as not irritant to rabbit eye.
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