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EC number: 416-250-2 | CAS number: 84632-59-7
- 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:
- 1993-05-13 - 1993-06-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD TG 404) performed under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted on 17 July 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 416-250-2
- EC Name:
- -
- Cas Number:
- 84632-59-7
- Molecular formula:
- C26 H28 N2 O2
- IUPAC Name:
- 3,6-bis(4-tert-butylphenyl)-1H,2H,4H,5H-pyrrolo[3,4-c]pyrrole-1,4-dione
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GMBH, Chemisch-pharmazeutische Fabrik, Biberach/Riss, Germany
- Age at study initiation: No data
- Weight at study initiation: 2300 - 2870 g
- Housing: Individually in metal cages.
- Diet: standard rabbit pellet – Nafag No. 814, Gossau, Switzerland, ad libitum
- Water: Fresh water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/- 3 °C
- Humidity: 30 - 70 %
- Air changes: No data
- Photoperiod: 12 hours light cycle day
IN-LIFE DATES: From: 1993-05-18 To: 1993-05-21
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g, moistened with 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours after patch removal (assessment of skin reactions at 1, 24, 48 and 72 hour(s) after patch removal)
- Number of animals:
- 3 males
- Details on study design:
- TEST ITEM PREPARATION
- 0.5 g (per animal) of the test item was moistened with 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80 before application.
TEST SITE
- 24 hours before treatment, both flanks were shaved
- Area of exposure: at least 36 cm² on the right flank
- Coverage: 6 cm² of the intact skin
- Type of wrap: Moistened surgical gauze patch (ca. 12– 16 cm²) with the test item - applied to approximately 6 cm² of the intact skin of the clipped area - covered with an occlusive dressing, dressing was wrapped around the abdomen and anchored with tape.
REMOVAL OF TEST SUBSTANCE
- No washing performed
SCORING SYSTEM: OECD scoring system
OBSERVATIONS
- Viability/Mortality: Daily
- Clinical signs: Daily
- Body weights: recorded at start and on day 3 of the test
- Necropsy: no
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No scoring possible in the 2 remaining rabbits at 24 h.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- IRRITATION:
The test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0). The mean values from 24 to 72 hours were therefore 0 for erythema and 0 for oedema.
CORROSION:
No irreversible alterations of the treated skin were observed nor were corrosive effects evident on the skin.
COLORATION
One hour after patch removal in all animals and 24 hours after patch removal in two animals a possible erythema reaction could not be evaluated because of test item-related orange staining.
Any other information on results incl. tables
VIABILITY/MORTALITY/CLINICAL SIGNS
No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
BODY WEIGHTS
The body weights of all rabbits were considered to be within the normal range of variability.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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