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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
Skin irritation / corrosion
Administrative data
- 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
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- 2,9-bis(p-methoxybenzyl)anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone
- EC Number:
- 280-472-4
- EC Name:
- 2,9-bis(p-methoxybenzyl)anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone
- Cas Number:
- 83524-75-8
- Molecular formula:
- C40H26N2O6
- IUPAC Name:
- 7,18-bis[(4-methoxyphenyl)methyl]-7,18-diazaheptacyclo[14.6.2.2²,⁵.0³,¹².0⁴,⁹.0¹³,²³.0²⁰,²⁴]hexacosa-1(23),2,4,9,11,13,15,20(24),21,25-decaene-6,8,17,19-tetrone
- Details on test material:
- Test materials used in this dossier are all considered to fall under the definition of nano-materials according to the European Commission Recommendation 2011/696/EU as the synthesis and manufacturing of this pigment always yields particulate material with a fine particle size distribution.
Constituent 1
Test animals
- 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
Test system
- 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
Results and discussion
In vivo
Resultsopen allclose all
- 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.
Any other information on results incl. tables
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 |
Applicant's summary and conclusion
- 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.
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