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EC number: 278-133-0 | CAS number: 75214-65-2
- 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:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Acid Black 222
- IUPAC Name:
- Acid Black 222
Constituent 1
Test animals / tissue source
- Species:
- rat
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Housing: in sigle cages.
- Diet: standard laboratory diet, ad libitum. The batch of diet used was analysed for chemical and microbiological contaminants.
- Water: ad libitum. The water bottles were withdrawn two hours prior and four hours after dosing.
- Acclimation period: 5 days.
- Health check: prior to the test, the eyes of each rabbit were exami ned for pre-existing casual injury.
ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 2 °C
- Humidity: 30 - 70 %
- Air changes: approximately 15 changes/hour.
- Photoperiod: 12 hrs dark / 12 hrs light.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 mg of test material was placed into the conjunctival sac.
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- Three male rabbits
- Details on study design:
- SCORING SYSTEM
The eyes were inspected after 30 minutes, 24, 48 and 72 hours.
Reading scores for ocular lesions were made according to the recommendations of the USA Food and Drug officials, published in 1959 (Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 1
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 1
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal:
- Time point:
- 24/48/72 h
- Score:
- < 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal:
- Time point:
- 24/48/72 h
- Score:
- < 2
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The irritation score resulted to be 0.83.
The substance can be considered as non irritating, according to the ETAD-Subcommittee for Toxicology and also according to the EC-Regulation.
Any other information on results incl. tables
Summary of ocular findings
Animal | Reaction | 30 min | 24 hrs | 48 hrs | 72 hrs | Mean 24/48/72 hrs |
1 male | Corneal opacity | 0 | 0 | 0 | 0 | 0.00 |
Iris | 0 | 0 | 0 | 0 | 0.00 | |
Conjunctival redness | 0 | 1 | 1 | 0 | 0.67 | |
Conjunctival chemosis | 0 | 0 | 0 | 0 | 0.00 | |
2 male | Corneal opacity | 0 | 0 | 0 | 0 | 0.00 |
Iris | 0 | 0 | 0 | 0 | 0.00 | |
Conjunctival redness | 0 | 1 | 1 | 0 | 0.67 | |
Conjunctival chemosis | 0 | 0 | 0 | 0 | 0.00 | |
3 male | Corneal opacity | 0 | 0 | 0 | 0 | 0.00 |
Iris | 0 | 0 | 0 | 0 | 0.00 | |
Conjunctival redness | 0 | 1 | 0 | 0 | 0.33 | |
Conjunctival chemosis | 0 | 0 | 0 | 0 | 0.00 |
Reactions scored
Animal | Reaction | 30 min | 24 hrs | 48 hrs | 72 hrs | |
1 male | Cornea | (A) dendity | 0 | 0 | 0 | 0 |
(B) area | 0 | 0 | 0 | 0 | ||
A×B×5 | 0 | 0 | 0 | 0 | ||
Iris | (C) | 0 | 0 | 0 | 0 | |
C×5 | 0 | 0 | 0 | 0 | ||
Conjunctiva | (D) secretion | 0 | 0 | 0 | 0 | |
(E) swelling | 0 | 0 | 0 | 0 | ||
(F) redness | 0 | 1 | 1 | 0 | ||
(D+E+F)×2 | 0 | 2 | 2 | 0 | ||
2 male | Cornea | (A) dendity | 0 | 0 | 0 | 0 |
(B) area | 0 | 0 | 0 | 0 | ||
A×B×5 | 0 | 0 | 0 | 0 | ||
Iris | (C) | 0 | 0 | 0 | 0 | |
Cx5 | 0 | 0 | 0 | 0 | ||
Conjunctiva | (D) secretion | 0 | 0 | 0 | 0 | |
(E) swelling | 0 | 0 | 0 | 0 | ||
(F) redness | 0 | 1 | 1 | 0 | ||
(D+E+F)x2 | 0 | 2 | 2 | 0 | ||
3 male | Cornea | (A) dendity | 0 | 0 | 0 | 0 |
(B) area | 0 | 0 | 0 | 0 | ||
AxBx5 | 0 | 0 | 0 | 0 | ||
Iris | (C) | 0 | 0 | 0 | 0 | |
C×5 | 0 | 0 | 0 | 0 | ||
Conjunctiva | (D) secretion | 0 | 0 | 0 | 0 | |
(E) swelling | 0 | 0 | 0 | 0 | ||
(F) redness | 0 | 1 | 0 | 0 | ||
(D+E+F)×2 | 0 | 2 | 0 | 0 | ||
Score 10 : 12 = 0.83 |
0 | 6 | 4 | 2 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified, according to the CLP Regulation (EC) No 1272/2008
- Conclusions:
- Non irritating
- Executive summary:
Three male rabbits were used to test the eye irritation potential of the substance. 100 mg of undiluted test material were placed into the conjunctival sac. The eyes were inspected after 30 minutes, 24, 48 and 72 hours. Reading scores for ocular lesions were made according to the recommendations of the USA Food and Drug officials, published in 1959 (Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics).
The irritation score resulted to be 0.83. The substance can be considered as non irritating, according to the ETAD-Subcommittee for Toxicology and also according to the EC-Regulation.
Conclusion
Although the criteria for the evaluation of the eye irritation potential followed in the test are different from those reported into the OECD guideline, the scoring system is the same. Raw tables are included into the study report, thus it is possible to re-evaluate the results according to the CLP Regulation (EC) No 1272/2008.
Mean values from gradings at 24, 48 and 72 hours were lower than 1 for corneal opacity, lower than 1 for iritis, lower than 2 for both conjunctival redness and chemosis, in all tested animals, thus the substance does not meet the criteria to be classified as eye irritating, according to the CLP Regulation (EC) No 1272/2008.
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