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EC number: 413-920-6 | CAS number: 88949-33-1
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Erythema could not be scored due to staining of the skin by the test substance.
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 413-920-6
- EC Name:
- -
- Cas Number:
- 88949-33-1
- Molecular formula:
- C30 H20 N2 O2
- IUPAC Name:
- 3,6-bis({[1,1'-biphenyl]-4-yl})-1H,2H,4H,5H-pyrrolo[3,4-c]pyrrole-1,4-dione
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- - Substance type: Organic
- Physical state: Solid
- Lot/batch No.: Z-2281/1,2,4,5
- Expiration date of the lot/batch: April 01, 1997
- Storage condition of test material: at room temperature in the dark
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Albino, SPF-Quality
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: Approx. 12 weeks
- Weight at study initiation: 2287 - 2600 grams
- Housing: individual
- Diet: Standard laboratory rabbit diet, approx. 100 g per day
- Water: Tap-water diluted with decalcified water, ad libitum
- Acclimation period: At least 5 days before start of treatment.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 55
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1992-11-24 To: 1992-11-27
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- The powdery test substance was applied with the aid of a patch. The patch was moistened with distilled water, immediately before application, to ensure close contact of the test substance to the animal's skin. - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h (Observations were made 1, 24, 48 and 72 hours after exposure)
- Number of animals:
- 3 male rabbits
- Details on study design:
- TEST SITE
- Approximately 24 hours before treatment, the dorsal fur was shaved with electric clippers
- Area of exposure: approximately 150 square centimeters (10 cm X 15 cm).
- Type of wrap if used: moistened Scotchpak-non-woven patch, mounted on Micropore tape. The dressing was wrapped around the abdomen and secured with an elastic bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the remaining test substance was removed using a tissue moistened with tap-water and subsequently a dry tissue
- Time after start of exposure: 4h
SCORING SYSTEM: Draize
- ERYTHEMA AND ESCHAR FORMATION
0 No erythema
1 Very slight erythema (barely perceptible)
2 Well defined erythema
3 Moderate to severe erythema
4 Severe erythema (beet redness) to slight eschar formation (injuries in depth)
- OEDEMA FORMATION
0 No oedema
1 Very slight oedema (barely perceptible)
2 Slight oedema (edges of area well defined by definite raising)
3 Moderate oedema (raised approximately 1 mm)
4 Severe oedema (raised more than 1 mm and extending beyond area of exposure)
Results and discussion
In vivo
Results
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- - Erythema: Erythema could not be scored due to staining of the skin by the test substance.
- Microscopic findings: No abnormalities were detected in either the treated skin-sites and reference control skin-sites by microscopical examination. The absence of microscopical detectable lesions in the skin, 72 hours after exposure, indicate that no or negligible irritation has occurred during the study period.
- Corrosion: There was no evidence of a corrosive effect on the skin. - Other effects:
- Toxicity symptoms / mortality: No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Any other information on results incl. tables
Table 1: Individual findings
Observation time | Rabbit no. 4266 | Rabbit no. 4268 | Rabbit no. 4270 | |||
Erythema | Oedema | Erythema | Oedema | Erythema | Oedema | |
1 Hour | - | 0 | - | 0 | - | 0 |
24 Hours | - | 0 | - | 0 | - | 0 |
48 Hours | - | 0 | - | 0 | - | 0 |
72 Hours | - | 0 | - | 0 | - | 0 |
Mean Value | - | 0.0 | - | 0.0 | - | 0.0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The facts that no oedema was observed during the study and microscopical examination of the treated skin sites after 72 hours revealed no abnormalities indicate that the test substance is not irritanting to skin.
- Executive summary:
A GLP conform in vivo study was performed to assess the acute dermal irritation/corrosion potential of the test substance (purity 97.5%) in White New Zealand rabbits according to the OECD guideline 404. Three male rabbits were exposed to 0.5 g of the test substance that was applied onto shaved skin using a semi-occlusive dressing. After 4 hours, the remaining test substance was removed. Observations were made 1, 24, 48 and 72 hours after exposure. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred. No oedema in the treated skin-areas of the rabbits were observed. Erythema could not be scored due to red staining of the skin by the test substance. However, microscopical examination revealed no abnormalities in either the treated skin-sites and reference control skin-sites 72 hours after exposure. The absence of microscopical detectable lesions in the skin indicate that no or negligible irritation has occurred during the study period. Therefore, the test substance is considered as non-irritating when applied to intact rabbit skin.
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