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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
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- Nanomaterial pour density
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- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
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- 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
Eye Irrit. 2, H319
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
- Study period:
- From December 13rd to 20th, 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Males
- Type of coverage:
- semiocclusive
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- Three rabbits
- Details on study design:
- TEST SITE
- Area of exposure: intact skin.
SCORING SYSTEM
Skin reactions were recorded 1,24,48,72 hours and 7 days after administration. The reactions were assessed according to the Draize J H (1959) "Dermal Toxicity" in Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. Assoc. of Food and Drug Officials of the US, Austin, Texas p47.
Primary Irritation Index / Classification
0 Non-iritant
> 0 - 2 Mild initant
> 2 - 5 Moderate initant
5 - 8 Severe initant - Irritation parameter:
- erythema score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 2.3
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 2.3
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Primary Irritation Index: 2.8
Very slight to well-defined erythema and very slight to slight oedema were noted at all treated skin sites. No other signs of skin irritation were noted. Pink coloured staining was noted at all treated skin sites. - Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- Moderate irritant
- Executive summary:
The study was performed to assess the irritation of the test material to the skin of the New Zealand White rabbit (SPL Standard Test Method 540.06). The method followed OECD Guidelines for Testing of Chemicals (1992) No. 404 "Acute Dermal Initation/Corrosion" and Method B4 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC). A single 4-hour semi-occluded application (0.5 g) of the test material was administered to the intact skin of three rabbits. Skin reactions were recorded 1, 24, 48, 72 hours and 7 days after administration.
Very slight to well-defined erythema and very slight to slight oedema were noted at all treated skin sites. No other signs of skin irritation were noted. Pink coloured staining was noted at all treated skin sites. Primary Irritation Index resulted to be 2.8.
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.
Conclusion
The test material did not meet the criteria for classification as irritant or corrosive according to the CLP Regulations EC 1272/2008. No symbol and risk phrase are required.
Reference
Individual Skin Reactions Following 4-hour Exposure Period
Animal No. Sex | Skin reaction | 1 hr | 24 hrs | 48 hrs | 72 hrs | 7 days | Mean 24, 48, 2 hrs |
124 M | Erythema | 1 STA | 2 STA | 2 STA | 1 STA | 0 | 1.7 |
141 M | Erythema | 2 STA | 2 STA | 2 STA | 1 STA | 0 | 1.7 |
145 M | Erythema | 2 STA | 2 STA | 2 STA | 1 STA | 0 | 1.7 |
Total | (5) | 6 | (6) | 3 | 0 | - | |
124 M | Oedema | 1 | 2 | 2 | 1 | 0 | 1.7 |
141 M | Oedema | 2 | 2 | 2 | 1 | 0 | 1.7 |
145 M | Oedema | 2 | 2 | 1 | 0 | 0 | 1.0 |
Total | (5) | 6 | (5) | 2 | 0 | - |
STA = Pink coloured staining
( ) = Total values not used for calculation of primary irritation index
Sum of 24 and72 How Readings (S): 17
Primary Irritation Index (S/6) and Classification*: 2.8; moderate irritant
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
- Study period:
- From December 17th, 2001 to January 28th, 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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
- Species:
- rabbit
- Strain:
- New Zealand White
- 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. - 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. - 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.
Reference
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
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
SKIN IRRITATION/CORROSION
A study was performed to assess the irritation of the Acid Violet 090 (AV090) to the skin of the New Zealand White rabbit. A single 4-hour semi-occluded application (0.5 g) of the test material was administered to the intact skin of three rabbits. Very slight to well-defined erythema and very slight to slight oedema were noted at all treated skin sites. No other signs of skin irritation were noted. Pink coloured staining was noted at all treated skin sites (Clariant SE, 2002).
An available summary reported some toxicological characteristics of AV090 (85 %; remaining composition sodium chloride and sodium sulfate) and included information on irration supports the study outcomes. Unfortunately the original study report is no more available. The information included in the toxicological characteristics sheet indicate the substance as not skin irritating (BASF SE, 1976).
EYE IRRITATION
The eye irritation potential of AV090 has been investigated following the OECD Guidelines 405 testing procedures. 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 substance was judged as at least a moderate irritant (class 5 ona 1- 8 scale) (Clariant SE, 2002).
The experiment conclusions agree with the information included into an available summary, which reports some toxicological characteristics of AV090 (85 %; remaining composition sodium chloride and sodium sulfate). Unfortunately the original study report is no more available. The information included in the toxicological characteristics sheet indicate the substance as slightly eye irritating (BASF SE, 1976).
REFERENCE
BASF SE. 1976. Ergrbnis der gewerbetoxikologischen vorprüfung. Testing laboratory: BASF AG. Date: 1976-11-26
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.
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 Regulation 1272/2008 (CLP) substances that have the potential to induce reversible eye irritation are classified in Category 2 (irritating to eyes) if, when applied to the eye of an animal, a substance produces at least in 2 of 3 tested animals, a positive response of corneal opacity ≥ 1 and/or iritis ≥ 1, and/or conjunctival redness ≥ 2 and/or conjunctival oedema (chemosis) ≥ 2, calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days.
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 three animals tested;
- iris score was equal to 1 in all three rabbits;
- redness and oedema scores were equal/higher than 2 in all three rabbits.
All the reactions resulted to be reversible within 21 days.
In conclusion, Acid Violet 090 is not classified for the skin irritation. On the contrary, it is classified as Eye. Irrit. 2 (H319), according to the CLP Regulation (EC 1272/2008).
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