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EC number: 263-319-6 | CAS number: 61916-41-4
- 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
- Study period:
- From December 17th, 2001 to January 28th, 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Acid Violet 090
- IUPAC Name:
- Acid Violet 090
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 ml (85 mg) of the test material was administered to the non inigated eye. - Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- Three rabbits (1 female and 2 males)
- Details on study design:
- SCORING SYSTEM
Ocular reactions were recorded 1, 24, 48 and 72 hours, 7, 14 and 21 days after administration.
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 - < 3
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- >= 2
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- >= 2
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Maximum Group Mean Score: 41.0; at least a moderate irritant (class 5 ona 1- 8 scale).
The test material produced scattered or diffuse to translucent corneal opacity, iridial inflammation and moderate to severe conjunctival irritation. Other ocular effects noted were petechial haemorrhage of the nictitating membrane or haemorrhage of the nictitating and lower conjunctival membranes.
Any other information on results incl. tables
Individual and Mean Scores for Cornear lris and Conjunctivae for EU Labelling Regulations
33 Female | Mean 24/48/72 hrs | 18 Male | Mean 24/48/72 hrs | 25 Male | Mean 24/48/72 hrs | |||||||
Time After Treatment | 24 hrs | 48 hrs | 72 hrs | 24 hrs | 48 hrs | 72 hrs | 24 hrs | 48 hrs | 72 hrs | |||
Degree of Comeal Opacity | 2S | 2S | 1 | 1.7 | 1 | 1 | 1 | 1.0 | 1S | 2S | 2S | 1.7 |
Iridial Inflammation |
1S | 1S | 1 | 1.0 | 1 | 1 | 1 | 1.0 | 1S | 1S | 1S | 1.0 |
Conjunctival Redness | 2S | 2S | 2H | 2.0 | 2SPt | 2S | 2 | 2.0 | 3S H* | 3S H* | 2S H* | 2.7 |
Conjunctival Chemosis | 2 | 2 | 2 | 2.0 | 3 | 2 | 1 | 2.0 | 3 | 3 | 2 | 2.7 |
Individual Scores for Ocular Irritation
33 Female | 18 Male | 25 Male | ||||||||||||||||||
Time After Treatment | 1hr | 24 hrs | 48 hrs | 72 hrs | 7 dy | 14 dy | 21 dy | 1hr | 24 hrs | 48 hrs | 72 hrs | 7 dy | 14 dy | 1hr | 24 hrs | 48 hrs | 72 hrs | 7 dy | 14 dy | 21 dy |
Degree of Comeal Opacity (E) | ?s | 2S | 2S | 1 | 0 | 0 | 0 | ?s | 1 | 1 | 1 | 0 | 0 | ?s | 1S | 2S | 2S | 1S | 1 | 0 |
Area of Corneal Opacity (F) | ?s | 2 | 1 | 1 | 0 | 0 | 0 | ?s | 4 | 3 | 2 | 0 | 0 | ?s | 4 | 4 | 3 | 2 | 1 | 0 |
Score (ExF)x5 | 0-80 | 20 | 10 | 5 | 0 | 0 | 0 | 0-80 | 20 | 15 | 10 | 0 | 0 | 0-80 | 20 | 40 | 30 | 10 | 5 | 0 |
Iridial Inflammation (D) |
?s | 1S | 1S | 1 | 0 | 0 | 0 | ?s | 1 | 1 | 1 | 1 | 0 | ?s | 1S | 1S | 1S | 1S | 1 | 0 |
Score (Dx5) | 0-10 | 5 | 5 | 5 | 0 | 0 | 0 | 0-10 | 5 | 5 | 5 | 5 | 0 | 0-10 | 5 | 5 | 5 | 5 | 5 | 0 |
Conjunctival Redness (A) | ?s | 2S | 2S | 2H | 1H | 1H | 0 | ?s | 2SPt | 2S | 2 | 1 | 0 | ?s | 3S H* | 3S H* | 2S H* | 2 H* | 1 | 0 |
Conjunctival Chemosis (B) | 2 | 2 | 2 | 2 | 0 | 0 | 0 | 2 | 3 | 2 | 1 | 1 | 0 | 2 | 3 | 3 | 2 | 1 | 1 | 0 |
Conjunctival Discharge (C) | 3Sf | 3Sf | 2Sf | 1Sf | 0Sf | 0Sf | 0Sf | 3Sf | 3Sf | 2 | 1 | 0Sf | 0Sf | 3Sf | 3Sf | 3Sf | 2Sf | 1Sf | 0Sf | 0Sf |
Score (A+B+C)x2 | 10-16 | 14 | 12 | 10 | 2 | 2 | 0 | 10-16 | 16 | 12 | 8 | 4 | 0 | 10-16 | 18 | 18 | 12 | 8 | 4 | 0 |
Total Score | 10-106 | 39 | 27 | 20 | 2 | 2 | 0 | 10-106 | 41 | 32 | 23 | 9 | 0 | 10-106 | 43 | 63 | 47 | 23 | 14 | 0 |
IPR = initial pain reaction
?s = purple/pink caloured staining prevented evalualion
S = purple/pink caloured staining
Sf = purple/pink caloured staining of the fur
H* = two areas of haemorrhage, approximately 2 mm x 2 mm in size, on edge of the nictitating membrane and lower conjunctival membrane
Pt = Petechial haemorrhage over the nictitating membrane
Applicant's summary and conclusion
- Interpretation of results:
- other: Eye Irrit. 2 (H319) according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- Eye irritant
- Executive summary:
The study was performed to assess the irritation of the test material to the eye of the New Zealand White rabbits (SPL Standard Test Method 560.07). The method followed OECD Guidelines for Testing of Chemicals (1987) No. 405 "Acute Eye Irritation/Corrosion" and Method B5 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).
A single application of 0.1 ml (85 mg) of the test material was administered to the eye of three rabbits. Ocular reactions were recorded 1, 24, 48 and 72 hours, 7, 14 and 2l days after administration.
Maximum Group Mean Score: 41.0; at least a moderate irritant (class 5 ona 1- 8 scale). The test material produced scattered or diffuse to translucent corneal opacity, iridial inflammation and moderate to severe conjunctival irritation. Other ocular effects noted were petechial haemorrhage of the nictitating membrane or haemorrhage of the nictitating and lower conjunctival membranes.
The mean values from gradings at 24, 48 and 72 hours were:
- cornea score was equal/higher than 1 and lower than 3 in all the animals tested;
- iris score was equal to 1 in all rabbits;
- redness and oedema scores were equal/higher than 2 in all rabbits.
All the reactions resulted to be reversible within 21 days.
Conclusion
The test material meets the criteria for classification as eye irritant, category 2 (H319) of the CLP Regulations EC 1272/2008.
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