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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
Endpoint summary
Administrative data
Description of key information
Non skin irritating
Non eye irritating
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin 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
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system 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.
ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 2 °C
- Humidity: 30 - 70 %
- Air changes: approximately 15 changes/hour.
- Photoperiod: 12 hrs dark / 12 hrs light. - Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- - Amout: 1.0 ml
- Vehicle: the substance was used diluted in 50 % water. - Duration of treatment / exposure:
- 4 hour
- Observation period:
- 72 hours
- Number of animals:
- Three male rabbits.
- Details on study design:
- TEST SITE
- Area of exposure: 24 hours prior to the test, the skin on the back of the animals was clipped by means of an electric clipper and the skin was investigated for pre-existing injuries. Test item was introduced under a square patch of surgical gauze measuring 6.5 cm2.
- Type of wrap if used: the animals were immobilized with patches secured in place by a plastic patch and the entire trunk was wrapped with a plasic sIeeve for the 4 hour exposure.
SCORING SYSTEM:
The irritation was measured by patch test technique on intact skin.
After 4 hours, the patches were removed and the resulting reactions were evaluated on the basis of the code of Federal Regulations, Title 16, Section 1500.41. - Irritation parameter:
- erythema score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 2.3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 2.3
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The irritation score was 0.0
The substance can be considered as non irritating, according to the ETAD-Subcommittee for Toxicology and also according to the EC-Regulation. - 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 skin irritation potential of the substance. The skin of rabbits was treated with 1.0 ml of test item, which was used diluted in 50 % water. The irritation was measured by patch test technique on the intact skin. After 4 hours, the patches were removed and the resulting reactions were evaluated on the basis of the code of Federal Regulations, Title 16, Section 1500.41.
None of the animals showed any observable response to treatment throughout the 72 hours observation period.
The irritation score was 0.0 and the substance has been judged to be non irritating, according to the ETAD-Subcommittee for Toxicology and also according to the EC-Regulation.
Conclusion
The scoring system criteria used to record the hardness of the skin reactions followed in the current test are the same as those reported into the OECD guideline, therefore it is possible to re-evaluate the results in accordance with the CLP Regulation (EC) No 1272/2008.
None of the animals showed any observable response to treatment throughout the 72 hours observation period, thus it can be concluded that the test item does not meet the criteria to be classified as irritating, according to the CLP Regulation (EC) No 1272/2008.
Reference
Animal | Reaction | 30 min | 24 hrs | 48 hrs | 72 hrs |
6 male | Erythema | 0 | 0 | 0 | 0 |
Oedema | 0 | 0 | 0 | 0 | |
7 male | Erythema | 0 | 0 | 0 | 0 |
Oedema | 0 | 0 | 0 | 0 | |
8 male | Erythema | 0 | 0 | 0 | 0 |
Oedema | 0 | 0 | 0 | 0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- not specified
- 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. - 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). - 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. - 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.
Reference
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 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
SKIN IRRITATION
The skin irritation potential of Acid Black 222 was assayed in two experiments, which were performed on test item with a different purity degree and dilution.
In both cases, three male rabbits were used and the irritation was measured by patch test technique on the intact skin. After 4 hours, the patches were removed and the resulting reactions were evaluated on the basis of the code of Federal Regulations, Title 16, Section 1500.41.
In both cases, none of the animals showed any observable response to treatment throughout the 72 hours observation period.
EYE IRRITATION
The eye irritation potential of Acid Black 222 was assayed in two experiments, which were performed on test item with a different purity degree and dilution.
Three male rabbits were used in both cases. The eyes were inspected after 30 minutes, 24, 48 and 72 hours and the 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).
In both cases, no reactions were scorded for corneal opacity, iritis and conjunctival chemosis. In case of test item with an higher purity degree, conjunctival redness was recorded in all tested animals; anyway, the mean for gradings was lower than 2 and all the effects were fully reversible within 72 hours.
Justification for classification or non-classification
According to the CLP Regulation (EC) No 1272/2008, 3.2 Skin corrosion/irritation section, skin irritation means the production of reversible damage to the skin following the application of a test substance for up to 4 hours.
The mean values from gradings at 24, 48 and 72 hours after patch removal were lower than 2.3 in all animals for both erythema/eschar and oedema reactions.
According to the CLP Regulation (EC) No 1272/2008, serious eye damage means the production of tissue damage in the eye, or serious physical decay of vision, following application of a test substance, which is not fully reversible within 21 days of application.
The 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 oedema, in all the tested animals. In addition, all the recorded effects were fully reversible within 72 hours.
In conclusion, the substance does not meet the criteria to be classified for eye/skin irritation, according to the CLP Regulation (EC) No 1272/2008.
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