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Diss Factsheets
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EC number: 250-054-6 | CAS number: 30112-70-0
- 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:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- July 28, 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- The test was conducted by means of Read Across approach. The reliability of the source study report is 2. Further information was attached at section 13
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: "Hazardous Substances Regulations" under the U.S.A. "Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965), with slight modification.
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Acid Orange 060 - Similar Substance 01
- IUPAC Name:
- Acid Orange 060 - Similar Substance 01
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 10 - 13 weeks
- Weight at study initiation: average body weights of 2.73 kg (males) and 2.38 kg (females)
- Housing:The rabbits were caged singly in an experimental room.
- Diet (e.g. ad libitum):A commercial irradiated diet (Styles-Oxoid) was fed ad libitum.
- Water (e.g. ad libitum):Sterile filtered water was available at all times.
- Acclimation period: Six rabbits were acclimatised in the test area for one week prior to the start of the trial
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1 °C
- Humidity (%): 50 - 70
- Photoperiod (hrs dark / hrs light):Animals were exposed to artificial light for 10 hours daily'from 08.00 - 18.00 hours
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The right eye served as a control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit) : 100 mg. - Duration of treatment / exposure:
- 30 seconds
- Observation period (in vivo):
- 1, 24, 48 and 72 hours
- Number of animals or in vitro replicates:
- Six rabbits (3 males and 3 females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): after 30 seconds the compound was, as far as possible, flushed out of the eyes' of three of the rabbits with warm water for 1 minute.
SCORING SYSTEM: the ocular reactions were scored by the method described in "Appraisal of the Safety of Chemicals in Food Drugs and Cosmetics" page 51, published by the Association of Food and Drug Officials of the U.S.A.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- redeness
- Basis:
- animal: 15
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: washed eyes
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: 14, 16
- Time point:
- 24/48/72 h
- Score:
- ca. 0.66
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: washed eyes
- Irritation parameter:
- chemosis score
- Basis:
- animal: 14, 15, 16
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: no symptoms
- Remarks on result:
- other: washed eyes
- Irritant / corrosive response data:
- A slight to moderate conjunctival reaction was seen in all treated eyes one hour after application of the compound. This had subsided slightly by 24 hours and thereafter continued to do so until all eyes were normal by 48 hours (1/3 washed) 72 hours (2/3 unwashed 2/3 washed) and 6 days (1/3 unwashed). Staining of the conjunctivae and cornea by the compound was seen in the unwashed eyes for up to 40 hours.
- Other effects:
- None
Any other information on results incl. tables
Rabbit eye irritation scores-reference procedure:
1 hour | 6 hours | 1 Day | 2 Days | 3 Days | 6 Days | |||||||||||||||||||||||||||||||||||||
Rabbit No | 11 | 13 | 15 | 12 | 14 | 16 | 11 | 13 | 15 | 12 | 14 | 16 | 11 | 13 | 15 | 12 | 14 | 16 | 11 | 13 | 15 | 12 | 14 | 16 | 11 | 13 | 15 | 12 | 14 | 16 | 11 | 13 | 15 | 12 | 14 | 16 | ||||||
Conjuctivae | ||||||||||||||||||||||||||||||||||||||||||
A | Redness | 2 | 2 | 2 | 2 | 1 | 1 | - | - | - | - | - | - | 1 | 2 | 1 | 2 | 1 | 1 | 1 | 1 | - | 1 | 1 | 1 | - | 1 | - | - | - | - | - | - | - | - | - | - | |||||
B | Chemosis | 2 | 2 | 1 | 2 | 1 | 2 | - | - | - | - | - | - | 1 | 1 | - | 1 | - | - | 1 | 1 | - | 1 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |||||
C | Discharge | 2 | 1 | - | 3 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |||||
c=(A+B+C) X2 | (max. 20) | 12 | 10 | 6 | 14 | 4 | 6 | - | - | - | - | - | - | 4 | 6 | 2 | 6 | 2 | 2 | 4 | 4 | - | 4 | 2 | 2 | - | 2 | - | - | - | - | - | - | - | - | - | - | |||||
Total | (Max.110) | 12 | 10 | 6 | 14 | 4 | 6 | - | - | - | - | - | - | 4 | 6 | 2 | 6 | 2 | 2 | 4 | 4 | - | 4 | 2 | 2 | - | 2 | - | - | - | - | - | - | - | - | - | - |
Eyes washed in Nos. 14, 15 & 16 hours
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- Not irritant
- Executive summary:
Method
The study was performed to determine the eye irriattion potential of the test substance in rabbits according to the procedure set out in the "Hazardous Substances Regulations" under the U.S.A. "Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965), with slight modification.
Conclusion
Not irritant
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