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EC number: 943-290-2 | CAS number: -
- 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
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- Auto flammability
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- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
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- Nanomaterial specific surface area
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- Nanomaterial surface chemistry
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- Endpoint summary
- Stability
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- 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:
- From 10 to 25 of July 1975
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Study following official guideline not in GLP
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: method given in the "Hazardous Substances Regulations" under the U.S. Federal Hazardous . Substances Labelling Act Sect. 191.12 (February 1965) with slight modification.
- GLP compliance:
- no
- Remarks:
- Pre GLP.
Test material
- Reference substance name:
- Similar Substance 01
- IUPAC Name:
- Similar Substance 01
- Test material form:
- solid: particulate/powder
- Details on test material:
- Acid Red 249
- Appearance: red power
- EC: 229-129-2
- CAS: 6416-66-6
- Alternative name: FAT 21070/B Polar Rot B Roh Trocken
- Purity: 90 %
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Number of animals: 6 (3 male; 3 female)
- Age at study initiation: 9 -14 weeks
- Weight at study initiation: 2.15 (male); 2.57 (female)
- Housing: singly caged
- Diet : commercial irradiated diet (Syles Oxoid), ad libitum
- Water : sterile water, ad libitum for all test duration
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C ± 2°
- Relative humidity: 50-70 %
- Photoperiod (hrs dark / hrs light): 10 hours of light (8:00-18:00)
Test system
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 mg of the test compound
- Duration of treatment / exposure:
- 1 second
- Observation period (in vivo):
- 1, 24, 48, 72 h after application and for any further period considered necessary (6 and 10 days)
- Number of animals or in vitro replicates:
- 6 (3 male and 3 female)
- Details on study design:
- TEST SITE
The eyes of the experimental animals were examined and found normal prior to the test.
REMOVAL OF TEST SUBSTANCE
After 30 seconds the compound was, as far as possible, flushed out of the eye of three of the rabbits with warm water For 1 minute.
SCORE SYSYEM
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:
- cornea opacity score
- Basis:
- animal: 15, 16
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 14
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- other: 15, 16
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal: 14
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: 15
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: 14, 16
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritant / corrosive response data:
- CONJUNTIVAL REACTION:
A mild to moderate reaction was seen in all treated eyes one hour after application of the compound.
This had subsided very slightly by 24 hours and thereafter continued to do so until all eyes had returned to normal by day 6 (1/3 unwashed, 3/3 washed) and 10 (2/3 unwashed). Staining of the conjunctivae by the compound was seen in the unwashed eyes at 24 hours.
CORNEAL REACTION:
Slight opacity and damage to the surface epithelium was seen in all treated eyes at one hour. This was still present at 24 hours. These returned to normal by 48 hours (2/3 washed), 72 hours (1/3 washed) and 6 days (3/3 unwashed).
IRIS:
Increased folding of the iris was seen in 2/3 unwashed eyes, (no. 11) at 24 hours and (no. 13) at 40 hours only.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not clasified according to CLP Regulation (EC) No. 1907/2006.
- Conclusions:
- Based on the evaluation of the overall score of the eye reaction on Cornea, Iris and Conjunctivae, the substance can be considered slightly irritant under the conditions of the study.
- Executive summary:
The determination of the eye irritation was determined in an eye irritation test. No guideline is available and the test was not performed on GLP. The reaction on the test substance was observed in albino rats for 10 days after the instillation. Reactions on Cornea, Conjunctivae and Iris were evaluated.
CONJUNTIVAL REACTION: a mild to moderate reaction was seen in all treated eyes one hour after application of the compound.
This had subsided very slightly by 24 hours and thereafter continued to do so until all eyes had returned to normal by day 6 (1/3 unwashed, 3/3 washed) and 10 (2/3 unwashed). Staining of the conjunctivae by the compound was seen in the unwashed eyes at 24 hours.
CORNEAL REACTION: slight opacity and damage to the surface epithelium was seen in all treated eyes at one hour. This was still present at 24 hours. These returned to normal by 48 hours (2/3 washed), 72 hours (1/3 washed) and 6 days (3/3 unwashed).
IRIS: increased folding of the iris was seen in 2/3 unwashed eyes, (no. 11) at 24 hours and (no. 13) at 40 hours only. Based on the evaluation of the overall score of the eye reactions of Cornea, Iris and Conjunctivae, the substance can be considered slightly irritant under the conditions of the study.
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