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EC number: 227-876-9 | CAS number: 6021-61-0
- 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
Endpoint summary
Administrative data
Description of key information
Not skin irritating
Not 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:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Housing: aII animals were housed in single cages.
- Diet: ad libitum. The batch of the diet used for this study was analysed for chemical and microbiological contaminants.
- Health check: 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.
- Acclimation period: all animals were acclimatized to the environment for a period of five days prior to the start of the study.
ENVIRONMENTAL CONDITIONS
- Temperature: 23 ± 2 °C
- Humidity: 50 ± 10 %
- Air changes: maintained at approximately 15 changes/hour.
- Photoperiod: light/dark cycle was 12 hours. - Type of coverage:
- occlusive
- Preparation of test site:
- other: intact and abraded skin
- Vehicle:
- other: DMSO
- Remarks:
- test item was prepared immediately before dosing
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 1.0 ml of the solution.
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- Three males and three females
- Details on study design:
- TEST SITE
- Area of exposure: test item was introduced under a square patch of surgical gauze, measuring 6.5 cm^2.
- Type of wrap if used: the animals were immobilzed with patches secured in place by a plastic patch and the entire trunk was wrapped with a plastic sleeve.
SCORING SYSTEM
After 24 hours, the patches were removed and the resulting reactions were evaluated on the basis of the code of Federal Regulation, title 16, Section 1500.41. - Irritation parameter:
- erythema score
- Basis:
- animal: 6/6
- Time point:
- 24/48/72 h
- Score:
- < 2.3
- Remarks on result:
- no indication of irritation
- Remarks:
- in none of the animals
- Irritation parameter:
- edema score
- Basis:
- animal: 6/6
- Time point:
- 24/48/72 h
- Score:
- < 2.3
- Remarks on result:
- no indication of irritation
- Remarks:
- in none of the animals
- Irritant / corrosive response data:
- The irritation score resulted to be 0.
Test item resulted to be non irritant according to the systen of classification recommended by the ETAD Subcommittee for toxicity. - Interpretation of results:
- other: not classified, according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- Not irritating
- Executive summary:
Six rabbits (three males and three females) were used to test the skin irritation potential of the substance. The abraded and intact skin of rabbits was treated with 1.0 ml of test solution. 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.
Conclusion
The scoring system criteria used to record the severity 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 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 1272/2008).
Reference
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:
- no
- Specific details on test material used for the study:
- Powdered formulation.
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Housing: aII animals were housed in single cages.
- Diet: a standard laboratory diet was provide ad libitum. The batch of the diet used for this study was analysed for chemical and microbiological contaminants.
- Health check: prior to the test, the eyes of each rabbit were examined for pre-existing casual injury.
- Acclimation period: all animals were acclimatized to the environment for a period of five days prior to the start of the study.
ENVIRONMENTAL CONDITIONS
- Temperature: 23 ± 2 °C
- Humidity: 50 ± 10 %
- Air changes: maintained at approximately 15 changes/hour.
- Photoperiod: light/dark cycle was 12 hours. - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 mg of the test material was placed into the conjunctival sac of the right eyes of the animals.
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- Nine rabbits: six rabbits for unwashed eyes and three addtional rabbits whose eyes were washed after instillation.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: in three animals, the treated eye was rinsed with 20 ml lukewarm water.
- Time after start of exposure: after half a minute.
OBSERVATION TIME
The eyes were inspected after 24, 48 and 72 hours.
SCORING SYSTEM:
Reading score 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: 9/9
- Time point:
- 24/48/72 h
- Score:
- < 1
- Remarks on result:
- no indication of irritation
- Remarks:
- in none of the animals
- Irritation parameter:
- iris score
- Basis:
- animal: 9/9
- Time point:
- 24/48/72 h
- Score:
- < 1
- Remarks on result:
- no indication of irritation
- Remarks:
- in none of the animals
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 9/9
- Time point:
- 24/48/72 h
- Score:
- < 2
- Remarks on result:
- no indication of irritation
- Remarks:
- in none of the animals
- Irritation parameter:
- chemosis score
- Basis:
- animal: 9/9
- Time point:
- 24/48/72 h
- Score:
- < 2
- Remarks on result:
- no indication of irritation
- Remarks:
- in none of the animals
- Irritant / corrosive response data:
- The irritation score resulted to be 0.
Test item resulted to be non irritant according to the systen of classification recommended by the ETAD Subcommittee for toxicity. - Interpretation of results:
- other: not classified, according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- Not irritating
- Executive summary:
Nine rabbits (New Zealand White Rabbits) were used in the test: six animals for unwashed eyes and three animals whose eyes were washed after instillation. Prior to the test, the eyes of each rabbit were examined for pre-existing casual injury.
100 mg of the test material was placed into the conjunctival sac of the right eyes of the animals. In three animals, the treated eye was rinsed after half a minute. The eyes were inspected after 24, 48 and 72 hours. Reading score 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, thus, the test item was judged to be non irritant, according to the systen of classification recommended by the ETAD Subcommittee for toxicity.
Conclusion
The scoring system criteria used to record the hardness of the skin reactions followed in the current test are strictly comparable to those reported into the OECD guideline, thus it is possible to re-evaluate the results in accordance with the CLP Regulation (EC 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 1272/2008).
Reference
Reactions - unwashed eyes
Animal | Reaction | 24 hrs | 48 hrs | 72 hrs | |
Male 701 | Cornea | (A) density | 0 | 0 | 0 |
(B) area | 0 | 0 | 0 | ||
A×B×5 | 0 | 0 | 0 | ||
Iris | (C) | 0 | 0 | 0 | |
C×5 | 0 | 0 | 0 | ||
Conjunctiva | (D) secretion | 0 | 0 | 0 | |
(E) swelling | 0 | 0 | 0 | ||
(F) redness | 0 | 0 | 0 | ||
(D+E+F)×2 | 0 | 0 | 0 | ||
Male 702 | Cornea | (A) density | 0 | 0 | 0 |
(B) area | 0 | 0 | 0 | ||
A×B×5 | 0 | 0 | 0 | ||
Iris | (C) | 0 | 0 | 0 | |
C×5 | 0 | 0 | 0 | ||
Conjunctiva | (D) secretion | 0 | 0 | 0 | |
(E) swelling | 0 | 0 | 0 | ||
(F) redness | 0 | 0 | 0 | ||
(D+E+F)×2 | 0 | 0 | 0 | ||
Male 703 | Cornea | (A) density | 0 | 0 | 0 |
(B) area | 0 | 0 | 0 | ||
A×B×5 | 0 | 0 | 0 | ||
Iris | (C) | 0 | 0 | 0 | |
C×5 | 0 | 0 | 0 | ||
Conjunctiva | (D) secretion | 0 | 0 | 0 | |
(E) swelling | 0 | 0 | 0 | ||
(F) redness | 0 | 0 | 0 | ||
(D+E+F)×2 | 0 | 0 | 0 | ||
Male 704 | Cornea | (A) density | 0 | 0 | 0 |
(B) area | 0 | 0 | 0 | ||
A×B×5 | 0 | 0 | 0 | ||
Iris | (C) | 0 | 0 | 0 | |
C×5 | 0 | 0 | 0 | ||
Conjunctiva | (D) secretion | 0 | 0 | 0 | |
(E) swelling | 0 | 0 | 0 | ||
(F) redness | 0 | 0 | 0 | ||
(D+E+F)×2 | 0 | 0 | 0 | ||
Male 705 | Cornea | (A) density | 0 | 0 | 0 |
(B) area | 0 | 0 | 0 | ||
A×B×5 | 0 | 0 | 0 | ||
Iris | (C) | 0 | 0 | 0 | |
C×5 | 0 | 0 | 0 | ||
Conjunctiva | (D) secretion | 0 | 0 | 0 | |
(E) swelling | 0 | 0 | 0 | ||
(F) redness | 0 | 0 | 0 | ||
(D+E+F)×2 | 0 | 0 | 0 | ||
Male 706 | Cornea | (A) density | 0 | 0 | 0 |
(B) area | 0 | 0 | 0 | ||
A×B×5 | 0 | 0 | 0 | ||
Iris | (C) | 0 | 0 | 0 | |
C×5 | 0 | 0 | 0 | ||
Conjunctiva | (D) secretion | 0 | 0 | 0 | |
(E) swelling | 0 | 0 | 0 | ||
(F) redness | 0 | 0 | 0 | ||
(D+E+F)×2 | 0 | 0 | 0 |
Reactions - washed eyes
Animal | Reaction | 24 hrs | 48 hrs | 72 hrs | |
Male 707 | Cornea | (A) density | 0 | 0 | 0 |
(B) area | 0 | 0 | 0 | ||
A×B×5 | 0 | 0 | 0 | ||
Iris | (C) | 0 | 0 | 0 | |
C×5 | 0 | 0 | 0 | ||
Conjunctiva | (D) secretion | 0 | 0 | 0 | |
(E) swelling | 0 | 0 | 0 | ||
(F) redness | 0 | 0 | 0 | ||
(D+E+F)×2 | 0 | 0 | 0 | ||
Male 708 | Cornea | (A) density | 0 | 0 | 0 |
(B) area | 0 | 0 | 0 | ||
A×B×5 | 0 | 0 | 0 | ||
Iris | (C) | 0 | 0 | 0 | |
C×5 | 0 | 0 | 0 | ||
Conjunctiva | (D) secretion | 0 | 0 | 0 | |
(E) swelling | 0 | 0 | 0 | ||
(F) redness | 0 | 0 | 0 | ||
(D+E+F)×2 | 0 | 0 | 0 | ||
Male 709 | Cornea | (A) density | 0 | 0 | 0 |
(B) area | 0 | 0 | 0 | ||
A×B×5 | 0 | 0 | 0 | ||
Iris | (C) | 0 | 0 | 0 | |
C×5 | 0 | 0 | 0 | ||
Conjunctiva | (D) secretion | 0 | 0 | 0 | |
(E) swelling | 0 | 0 | 0 | ||
(F) redness | 0 | 0 | 0 | ||
(D+E+F)×2 | 0 | 0 | 0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
SKIN IRRITATION
The potential for skin irritation of Disperse Red 054 was assessed in rabbits. The irritation was measured by patch test technique on the intact and abraded skin. The 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.
Additional experiments, conducted on Direct Red 054, are available; however, they were performed using a sample with a limited content of test item, thus, they are here reported just as a supporting studies.
In both the supporting studies, the procedures employed were those prescribed by the consumer product safety commission of the U.S.A, according to the ETAD method No 002.
In one case, the primary irritation index was found to be 0.8 and the substance was judged to be slightly irritating, according to the ETAD-Subcommittee for Toxicology.
In the other case, very slight oedema only was observed in the intact and abraded sites of two animals at the 24 hours reading; similar reactions were observed in one of these animals at the 72 hours reading. However, four animals did not show any observable response to treatment throughout the 72 hours observation period. The primary irritation index was estimated to be 0.3 and the substance was judged to be non irritating, according to the ETAD-Subcommittee for Toxicology.
EYE IRRITATION
The potential for eye irritation of Disperse Red 054 was assessed in rabbits. Nine animals were used in the test: six animals for unwashed eyes and three animals whose eyes were washed after instillation. The eyes were inspected after 24, 48 and 72 hours and the reading score 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, thus, the test item was judged to be non irritant, according to the system of classification recommended by the ETAD Subcommittee for toxicity.
In addition a second experiment, conducted on Direct Red 054 , is available; however, it was performed using a sample with a limited content of test item, thus, it is here reported just as a supporting study. The substance was tested in six rabbits, which were treated with 66 mg of test item. The ocular reactions were scored by the method described by J.H. Draize in "Appraisal of the Safety of Chemicals in Foods, Drugs ond Cosmetics" p 51, 1959 and categorized from the mean values as recommended by the ETAD Sub-committee for Toxicology. Mild conjunctival inflammation was observed in three animals 24 hours after instillation only. Three animals did not show any observable response to treatment throughout the 7 day observation period. The mean Draize score at days 1, 2 and 3 resulted to be 0.2 and the test item was judged to be "non irritant".
Justification for classification or non-classification
According to the CLP Regulation (EC 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.
In the key experiment, 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 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 of the tested animals.
In conclusion, the substance does not meet the criteria to be classified for the eye/skin irritation, according to the CLP Regulation (EC 1272/2008).
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