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Reaction mass of trisodium [m[7-[[4'-[[6-benzamido-1-hydroxy-3-sulpho-2-naphthyl]azo]-3,3'-dihydroxy[1,1'-biphenyl]-4-yl]azo]-8-hydroxynaphthalene-1,6-disulphonato(7-)]]dicuprate(3-) and trisodium [m[4-[[4'-[[6-benzamido-1-hydroxy-3-sulpho-2-naphthyl]azo]-3,3'-dihydroxy[1,1'-biphenyl]-4-yl]azo]-3-hydroxynaphthalene-2,7-disulphonato(7-)]]dicuprate(3-)
EC number: 947-266-2 | 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
- 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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- 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: all animals were housed in single cages.
- Diet: a standard laboratory diet was provided ad libitum. The batch of the diet used for this study was analysed for chemical and microbiological contaminants.
- Water: water was provided ad libitum.
- 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: the room temperature was maintained within a median of 21 ± 2 °C recorded by a maximum-minimum thermometer.
- Humidity: 30 - 70 %, measured by a hygrometer.
- Air changes: the rate of air exchange was maintained at approximately 15 changes/hour.
- Photoperiod: the light/dark cycle was 12 hours. - Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- other: the substance was diluted with WEM (50 %)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 1.0 ml of solution
- Duration of treatment / exposure:
- 4 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 and the skin was investigated for pre-existing injuries. Test item was applied by 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 plastic sleeve.
SCORING SYSTEM
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 Regulation, 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 resulted 0.00, thus the substance was considered to be non-irritant.
- Interpretation of results:
- other: not classified, according to the CLP Regulation (EC) No 1272/2008
- Conclusions:
- Non-irritant
- Executive summary:
Three male rabbits were used to assay the skin irritation potential of the test item. 1.0 ml of the solution (test item diluted with WEM (50 %)) were placed on the surgical gauze and place in contact with skin over a period of 4 hours. 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 Regulation, Title 16, Section 1500.41.
The irritation score resulted 0.00, thus the substance was considered to be non-irritant.
Conclusion
Although the criteria for the evaluation of the skin irritation potential followed in the test are different from those reported into the OECD guideline, the scoring system is the same. Because the raw tables are included into the study report, it is possible to re-evaluate the results according to the CLP Regulation (EC) No 1272/2008. The mean values from gradings at 24, 48 and 72 hours were lower than 2.3 for both the erythema and oedema. Thus the substance does not meet the criteria to be classified as skin irritating, according to the CLP Regulation (EC) No 1272/2008.
Reference
Individual reactions
Animal | Reaction | 30 min | 24 hrs | 48 hrs | 72 hrs | Mean 24/48/72 hrs |
Animal 1 | Erythema | 0 | 0 | 0 | 0 | 0 |
Animal 2 | Erythema | 0 | 0 | 0 | 0 | 0 |
Animal 3 | Erythema | 0 | 0 | 0 | 0 | 0 |
Animal 1 | Oedema | 0 | 0 | 0 | 0 | 0 |
Animal 2 | Oedema | 0 | 0 | 0 | 0 | 0 |
Animal 3 | Oedema | 0 | 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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Housing: all animals were housed in single cages.
- Diet: a standard laboratory diet was provided ad libitum. The batch of the diet used for this study was analysed for chemical and microbiological contaminants.
- Water: water was provided ad libitum.
- Acclimation period: all animals were acclimatized to the environment for a period of five days prior to the start of the study.
- Health check: prior to the test, the eyes of each rabbit were examined for pre-existing casual injury.
ENVIRONMENTAL CONDITIONS
- Temperature: the room temperature was maintained within a median of 21 ± 2 °C recorded by a maximum-minimum thermometer.
- Humidity: 30 - 70 %, measured by a hygrometer.
- Air changes: the rate of air exchange was maintained at approximately 15 changes/hour.
- Photoperiod: the 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:
- Three male rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: eyes unwashed.
SCORING SYSTEM
The eyes were inspected after 30 min, 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 Safet 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: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 2
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- chemosis score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 2
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The irritation score resulted 0.67, thus the substance was considered to be non-irritant.
- Interpretation of results:
- other: not classified, according to the CLP Regulation (EC) No 1272/2008
- Conclusions:
- Non-irritant
- Executive summary:
Three male rabbits were used to assay the eye irritation potential of the test item. 100 mg of the substance were placed into the conjunctival sac of the right eyes of the animals. Eye were not washed; they were were inspected after 30 min, 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 Safet of Chemicals in Foods, Drugs and Cosmetics).
The irritation score resulted 0.67, thus the substance was considered to be non-irritant.
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. Because the raw tables are included into the study report, it is possible to re-evaluate the results according to the CLP Regulation (EC) No 1272/2008. 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, thus the substance does not meet the criteria to be classified as eye irritating, according to the CLP Regulation (EC) No 1272/2008.
Reference
Individual reaction
Animal | Reaction | 30 min | 24 hrs | 48 hrs | 72 hrs | mean 24/48/72 hrs |
Animal 1 | Corneal opacity | 0 | 0 | 0 | 0 | 0.00 |
Animal 2 | Corneal opacity | 0 | 0 | 0 | 0 | 0.00 |
Animal 3 | Corneal opacity | 0 | 0 | 0 | 0 | 0.00 |
Animal 1 | Iris | 0 | 0 | 0 | 0 | 0.00 |
Animal 2 | Iris | 0 | 0 | 0 | 0 | 0.00 |
Animal 3 | Iris | 0 | 0 | 0 | 0 | 0.00 |
Animal 1 | Conjunctival redness | 0 | 0 | 0 | 0 | 0.00 |
Animal 2 | Conjunctival redness | 0 | 1 | 0 | 0 | 0.33 |
Animal 3 | Conjunctival redness | 0 | 2 | 1 | 0 | 1.00 |
Animal 1 | Conjunctival chemosis | 0 | 0 | 0 | 0 | 0.00 |
Animal 2 | Conjunctival chemosis | 0 | 0 | 0 | 0 | 0.00 |
Animal 3 | Conjunctival chemosis | 0 | 0 | 0 | 0 | 0.00 |
Animal | Findings | 30 min | 24 hrs | 48 hrs | 72 hrs | |
Animal 1 | Cornea | (A) density | 0 | 0 | 0 | 0 |
(B) area | 0 | 0 | 0 | 0 | ||
AxBx5 | 0 | 0 | 0 | 0 | ||
Iris and aspect |
(C) | 0 | 0 | 0 | 0 | |
Cx5 | 0 | 0 | 0 | 0 | ||
Conjuntiva | (D) secretion | 0 | 0 | 0 | 0 | |
(E) swelling | 0 | 0 | 0 | 0 | ||
(F) redness | 0 | 0 | 0 | 0 | ||
(D+E+F) x 2 | 0 | 0 | 0 | 0 | ||
Animal 2 | Cornea | (A) density | 0 | 0 | 0 | 0 |
(B) area | 0 | 0 | 0 | 0 | ||
AxBx5 | 0 | 0 | 0 | 0 | ||
Iris and aspect | (C) | 0 | 0 | 0 | 0 | |
Cx5 | 0 | 0 | 0 | 0 | ||
Conjuntiva | (D) secretion | 0 | 0 | 0 | 0 | |
(E) swelling | 0 | 0 | 0 | 0 | ||
(F) redness | 0 | 1 | 0 | 0 | ||
(D+E+F) x 2 | 0 | 2 | 0 | 0 | ||
Animal 3 | Cornea | (A) density | 0 | 0 | 0 | 0 |
(B) area | 0 | 0 | 0 | 0 | ||
AxBx5 | 0 | 0 | 0 | 0 | ||
Iris and aspect | (C) | 0 | 0 | 0 | 0 | |
Cx5 | 0 | 0 | 0 | 0 | ||
Conjuntiva | (D) secretion | 0 | 0 | 0 | 0 | |
(E) swelling | 0 | 0 | 0 | 0 | ||
(F) redness | 0 | 2 | 1 | 0 | ||
(D+E+F) x 2 | 0 | 4 | 2 | 0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
SKIN IRRITATION
Three male rabbits were used to assay the skin irritation potential of Direct Blue 251. 1.0 ml of the solution (test item diluted with WEM (50 %)) were placed on the surgical gauze and place in contact with skin over a period of 4 hours. After 4 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. The irritation score resulted 0.00, thus the substance was considered to be non-irritant.
Although the criteria for the evaluation of the skin irritation potential followed in the test are different from those reported into the OECD guideline, the scoring system is the same. Because the raw tables are included into the study report, it is possible to re-evaluate the results according to the CLP Regulation (EC) No 1272/2008.
EYE IRRITATION
Three male rabbits were used to assay the eye irritation potential of the Direct Blue 251. 100 mg of the substance were placed into the conjunctival sac of the right eyes of the animals. Eye were not washed; reading scores for ocular lesions were made according to the recommendations of the USA Food and Drug officials, published in 1959 (Appraisal of the Safet of Chemicals in Foods, Drugs and Cosmetics). The irritation score resulted 0.67, thus the substance was considered to be non-irritant.
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. Because the raw tables are included into the study report, it is possible to re-evaluate the results according to the CLP Regulation (EC) No 1272/2008.
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 were lower than 2.3 for both the erythema and oedema, thus the substance does not meet the criteria to be classified as skin irritating.
According to the CLP Regulation (EC) No1272/2008, 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. Eye irritation means the production of changes in the eye, which are 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; all the reactions recorded were fully reversible within 72 hours. Thus, the substance does not meet the criteria to be classified as eye irritating.
In conclusion, the substance does not meet the criteria to be classified for the skin/eye irritation potential, according to the CLP Regulation (EC) No 1272/2008.
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