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Diss Factsheets
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EC number: 213-879-2 | CAS number: 1047-16-1
- 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
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Endpoint summary
Administrative data
Description of key information
Skin irritation/Corrosion:
Pigment violet 19 (nano and not specified form): not irritating
Eye irritation:
Structure analogue: Pigment violet 19 (nano form): not irritating (OECD 405)
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 2 APR 1979 to 5 APR 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given: comparable to guidelines
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- other: FDA guideline (Federal Register 38, No. 187, 27.9.1973)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: in house breeding (Hoe:HIMK(SPFWiga))
- Weight at study initiation: 1.5 to 2.5 kg
- Housing: single caged
- Diet: standard diet ERKA 8300 (Futtermittelwerk Robert Koch oHG, Hamm/Westfalen, Germany), ad libitum
- Water: ad libitum - Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped, partially scarified
- Vehicle:
- other: polyethylene glycol 400
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg of test substance pasted with 0.7 mL of of PEG400 - Duration of treatment / exposure:
- 24 h
- Observation period:
- 72 h
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm²
- Type of wrap if used: occlusive elastic bandage
- test item was applied to intact as well as scarified skin of each animal
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h
SCORING SYSTEM: described in § 1500.41 in Fed. Reg. 38, No. 187, 27.09.1973, p.27019, in accordance with OECD TG 404.
Scores were assessed 24, 48 and 72 h after start of exposure, which lasted for 24 h. For classification, the readings are stated here as immediately, 24 and 48 h after end of exposure. - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: result for intact as well as scarified skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: result for intact as well as scarified skin
- Irritant / corrosive response data:
- - none of the animals showed oedema or erythema at the intact or scarified skin at any time point (immediately, 24 and 48 hours after end of exposure)
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP regulation
- Conclusions:
- According to the classification criteria of Regulation (EC) No 1272/2008 the test material is not irritating to skin under these test conditions. This conclusion is legitimate although the testing regime differs from today's standard methods (e.g., exposure of intact and scarified skin, application period 24 hours instead of 4 hours, deviating reading times, scoring system is identical to the currently used system), because no skin reactions were observed in any animal at any timepoint. The test material contains relevant amounts of the submission substance. Therefore the test results are considered adequate to fulfil the endpoint requirements.
- Executive summary:
Test material was subject to an acute dermal irritation/corrosion test in 6 Himalayan albino rabbits according to FDA guideline. Both intact and scarified skin sites of six rabbits were exposed to 500 mg test substance (pasted in 0.7 mL PEG 400) for 24 h under occlusive conditions and the skin responses were watched for up to 48 hours after end of exposure. No skin reactions were observed. Therefore, the test item has not to be classified for skin irritation according to Regulation (EC) No 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
- Study period:
- From 2 AUG 1988 to 5 AUG 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD TG 405)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hoechst Ag, Kastengrund, conventional breeding
- Age at study initiation: approx. 3 to 5 months
- Weight at study initiation: 3.2 to 3.7 kg
- Housing: single caged in fully conditioned rooms
- Diet: Altromin 2123 rabbit diet (Altromin GmbH, Lage/Lippe, Germany), ad libitum; hay, approx. 15 g/d
- Water: deionised, chlorinated water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-3
- Humidity (%): 50 +/-20
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: with physiological solution of sodium chloride (37 °C)
- Time after start of exposure: 24 h (and at every reading when discharge of the eyes occurred or sodium-fluorescein was used for scoring)
SCORING SYSTEM: according to OECD TG 405
TOOL USED TO ASSESS SCORE: at 48 and 72 h reading 1 drop of sodium-fluorescein (0.1%) added for scoring - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: redness
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Remarks on result:
- other: redness
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: redness
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- - Conjunctival redness was observed in 3/3 animals at one hour after instillation of the test item (score (redness): 1) as well as in 2/3 animals at the 24 h reading. This effect was fully reversible by 48 hours after application.
- No effects on cornea, iris, or chemosis occurred (score 0 at every time point) - Other effects:
- There was discharge observed in all animals one hour after instillation of the test material.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP regulation
- Conclusions:
- According to the classification criteria of Regulation (EC) No 1272/2008 the test material is not irritating to eyes under these test conditions. Test material contains relevant amounts of the submission substance. Therefore the test results are considered adequate to fulfil the endpoint requirements.
- Executive summary:
Test material was subject to an acute eye irritation/corrosion test in 3 rabbits according to OECD TG 405. No corneal or iridial effects were observed. Chemosis was not found likewise. Conjunctival redness was observed in 3/3 animals at one hour after instillation of the test item (score (redness): 1) as well as in 2/3 animals at the 24 h reading. This effect was fully reversible by 48 hours after application. As the mean values of the observed eye responses fall below the critical values for classification according to the criteria of Regulation (EC) No 1272/2008, the test material is not irritating to eyes and has not to be classified for eye irritation.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
No classification
The test material was not irritant to skin and eyes in in vivo assays in rabbits.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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