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EC number: 280-472-4 | CAS number: 83524-75-8
- 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
Skin irritation/corrosion: non-irritating, according to OECD TG 404, no GLP compliance, 0.5 ml of the test substance (50 % in water), occlusive, 4 h, rabbit, 1982, K2
Eye irritation: non-irritating, according to OECD TG 405, no GLP compliance, 0.1 ml of the test substance, no washing, rabbit, 1982, K2
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
- Remarks:
- only a 50% aqueous preparation was tested
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler; D-6050 Offenbach/Main, FRG
- Housing: Stainless steel with wire mesh walk floor, floor area: 40 cm x 51 cm
- Diet (e.g. ad libitum): Ovator Solikanin 4 mm; Muskator-Werke, D-4000 Düsseldorf 1, FRG (about 130 g per animal daily)
- Water (e.g. ad libitum): 250 ml tap water per animal daily
- Acclimation period: At least approx. 8 days in the skin laboratory before the beginning of the study; same housing conditions as during the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes (per hr): fully airconditioned rooms
- Photoperiod (hrs dark / hrs light): 12 / 12 - Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- other: untreated skin of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 50% aqueous preparation
Application volume: Wetting of the test patch with a layer of approx. 0.5 ml of the 50% preparation (the test patch measures 2.5 x 2.5 cm and thus about 0.5 g is applied; due to the natural moisture of the skin, distilled water is used for preparing the preparations in order to carry out the test under conditions am physiological as possible. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 30 - 60 minutes after removal of the test patches and 24 hours, 48 hours, 72 hours and 8 days after the beginning of application
- Number of animals:
- 2 females, 1 male
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with Lutrol and Lutrol/water (1:1)
- Time after start of exposure: 4 h
SCORING SYSTEM: Scale for scoring of erythema and edema:
0 = None
1 = Very slight
2 = Well-defined
3 = Moderate to severe
4 = Severe to very severe - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 4 h
- Score:
- 2
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.9
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 4 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- After 4 hours, erythema score 2 (extending beyond the area of exposure) was observed in all animals; edema score 1 was observed in one animal; edema extending beyond the area of exposure in one animal.
After 24 hours, erythema extending beyond the area of exposure (score 1 in two animals and score 2 in one animal). In two animals, the erythema persisted at score 1 until the 72 h time point. reversibvle within 8 days. - Other effects:
- No abnormalities identified at necropsy.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of this study, the test article caused a mild irritation response below the level of regulatory significance and is therefore considered to be not irritating to the rabbit skin.
- Executive summary:
In a skin irritation study following OECD guideline 404, 500 mg of a 50% aequous preparation of the test substance was applied to the left flanks of three Vienna White rabbits. The untreated right flan served as control. The animals were observed for 8 days. An edema extending beyond the area of exposure with a score of 1 was observed in one animal after 4 hours, reversible within 24 hours. In addition, erythema formation (score = 2) was observed in all animals 4 hours after exposure. The erythema extended beyond the area of exposure in all animals at this observation time point. The severity of erythema decreased during the observation period and was fully reversible in all animals within 8 days. The mean (24/48/72 h) erythema and edema scores were 0.9 and 0, respectively. Based on the results of this study, the test article caused a mild irritation response below the level of regulatory significance and is therefore considered to be not irritating to the rabbit skin.
Reference
Overview on results:
Animal 1 | Animal 2 | Animal 3 | ||
erythema | 4 h | 2 | 2 | 2 |
24 h | 2 | 1 | 1 | |
48 h | 1 | 1 | 0 | |
72 h | 1 | 1 | 0 | |
8 d | 0 | 0 | 0 | |
edema | 4 h | 0 | 0 | 1 |
24 h | 0 | 0 | 0 | |
48 h | 0 | 0 | 0 | |
72 h | 0 | 0 | 0 | |
8 d | 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:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler; D-6050 Offenbach/Main, FRG
- Weight at study initiation: 2.79, 2,89 and 2.93 kg (individual weights)
- Housing: Stainless steel with wire mesh walk floor, floor area: 40 cm x 51 cm
- Diet (e.g. ad libitum): Ovator Solikanin 4 mm; Muskator-Werke D-4000 Düsseldorf 1, FRG (about 130 g per animal daily)
- Water (e.g. ad libitum): About 250 ml tap water per animal, daily
- Acclimation period: At least approx. 8 days in the skin laboratory before the beginning of the study; same housing conditions as during the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 -24
- Humidity (%): 30 - 70
- Air changes (per hr): Fully airconditioned room
- Photoperiod (hrs dark / hrs light): 12 / 12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL (ca. 28 mg) - Duration of treatment / exposure:
- one single application, no washing was performed
- Observation period (in vivo):
- 1 h, 24 h, 48 h, 72 h, 8 d after application
- Number of animals or in vitro replicates:
- 2 females, 1male
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 2
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days (one animal had a conjunctivae score of 1 after 8 days)
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- The ocular reactions observed were below the regulatory threshold. The remaining redness at the end of observation in one animal is expected to resolve eventually.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of this study, the test article caused mild ocular reactions below the level of significance and is therefore regarded as not irritating to the rabbit eye.
- Executive summary:
In an eye irritation study following OECD guideline 405, 0.1 ml of the test substance was applied undiluted into the eyes of three Vienna White rabbits. The test animals were observed for eight days and irritation scores were recorded 1, 24, 48 and 72 hours and 8 days after the instillation. No effects in the cornea and iris were observed at any observation time point. The mean scores (24, 48, 72 hours) for conjunctival redness and chemosis were 1.3 and 0.3, respectively. One animal displayed a conjunctival redness of at the end of the observation period with a score of 1 (full reversibility is expected after longer observation). Chemosis was fully reversible within 48 hours. Based on the results of this study, the test article caused mild ocular reactions below the level of significance and is therefore regarded as not irritating to the rabbit eye.
Reference
Overview of results:
Animal 1 | Animal 2 | Animal 3 | ||
cornea | 1 h | 0 | 0 | 0 |
24 h | 0 | 0 | 0 | |
48 h | 0 | 0 | 0 | |
72 h | 0 | 0 | 0 | |
8 d | 0 | 0 | 0 | |
redness | 1 h | 2 | 2 | 2 |
24 h | 2 | 2 | 2 | |
48 h | 1 | 1 | 1 | |
72 h | 1 | 1 | 1 | |
8 d | 1 | 0 | 0 | |
chemosis | 1 h | 1 | 1 | 1 |
24 h | 1 | 1 | 1 | |
48 h | 0 | 0 | 0 | |
72 h | 0 | 0 | 0 | |
8 d | 0 | 0 | 0 | |
Iris | 1 h | 0 | 0 | 0 |
24 h | 0 | 0 | 0 | |
48 h | 0 | 0 | 0 | |
72 h | 0 | 0 | 0 | |
8 d | 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
In a skin irritation study following OECD guideline 404, 500 mg of a 50% aequous preparation of the test substance was applied to the left flanks of three Vienna White rabbits (BASF AG, 1982). The untreated right flan served as control. The animals were observed for 8 days. An edema extending beyond the area of exposure with a score of 1 was observed in one animal after 4 hours, reversible within 24 hours. In addition, erythema formation (score = 2) was observed in all animals 4 hours after exposure. The erythema extended beyond the area of exposure in all animals at this observation time point. The severity of erythema decreased during the observation period and was fully reversible in all animals within 8 days. The mean (24/48/72 h) erythema and edema scores were 0.9 and 0, respectively. Based on the results of this study, the test article caused a mild irritation response below the level of regulatory significance and is therefore considered to be not irritating to the rabbit skin.
Eye irritation
In an eye irritation study following OECD guideline 405, 0.1 ml of the test substance was applied undiluted into the eyes of three Vienna White rabbits (BASF AG, 1982). The test animals were observed for eight days and irritation scores were recorded 1, 24, 48 and 72 hours and 8 days after the instillation. No effects in the cornea and iris were observed at any observation time point. The mean scores (24, 48, 72 hours) for conjunctival redness and chemosis were 1.3 and 0.3, respectively. One animal displayed a conjunctival redness of at the end of the observation period with a score of 1 (full reversibility is expected after longer observation). Chemosis was fully reversible within 48 hours. Based on the results of this study, the test article caused mild ocular reactions below the level of significance and is therefore regarded as not irritating to the rabbit eye.
Further toxicological data of category members:
Reliable data from several studies on irritation are available for the test article and for other members of the "perylene based pigments" category (see attached category justification). All of these data are taken into account for the evaluation and assessment of the irritation potential of the test article. Studies concerning the irritating potential for skin and eyes are available for all category members. In no study evidence for irritating or corrosive effects of the substances was observed. The category members can therefore all considered as not irritating to the skin and eyes.
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. An OECD 404 study is available for skin irritation. An OECD 405 study is available for eye irritation. In both studies, the scores for the test item treated tissues were below the thresholds for classification as an irritant. As a result, the substance is not considered to be classified for skin or eye irritation under Regulation (EC) No. 1272/2008, as amended for the fourteenth time in Regulation (EC) No. 2020/217.
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