Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992
- 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 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- When this study was performed, the LLNA did not yet exist.
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
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Prior to each intradermal treatment, the test substance was weighed into small glass containers, polyethylene glycol was added (w/w) and subsequently mixed using a mechanical stirrer and/or spatula.
- Prior to each epidermal treatment, the test substance was weighed into a mortar, vaseline was added (w/w) and subsequently mixed using a pestle.
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Himalayan
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: BRL Ltd., Basel, Switzerland
- Age at study initiation: Approx. 8 weeks
- Weight at study initiation: 318 - 450 grams
- Housing: 2 animals per cage
- Diet: standard guinea pig diet, including ascorbic acid (1600 mg/kg), ad libitum and hay, once weekly
- Water: tap-water, diluted with decalcified water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 55
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1992-09-15 To: 1992-10-16
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- 5% (w/w) test substance, 0.1 mL/site
- Day(s)/duration:
- Day 1; once
- Adequacy of induction:
- not specified
- Route:
- intradermal
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- vehicle control; 0.1mL/site
- Day(s)/duration:
- Day 1; once
- Route:
- intradermal
- Vehicle:
- other: Freunds' Complete Adjuvant (FCA)
- Concentration / amount:
- 50:50 with distilled water, 0.1mL/site
- Day(s)/duration:
- Day 1; once
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: vaseline
- Concentration / amount:
- 50% (w/w) test substance; 0.5 mL/site
- Day(s)/duration:
- Day 8; 48h
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: vaseline
- Concentration / amount:
- vehicle control
- Day(s)/duration:
- Day 8; 48h
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: vaseline
- Concentration / amount:
- 10, 25, 50% (w/w) test substance
- Day(s)/duration:
- 24h
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #1
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: vaseline
- Concentration / amount:
- vehicle control
- Day(s)/duration:
- 24h
- No. of animals per dose:
- Preliminary study: 5
Main study: 20 (test item), 10 (control) - Details on study design:
- RANGE FINDING TESTS:
- Intradermal injections: Four Intradermal injections (0.1 ml/site) of one guinea pig with a 5% (w/w) concentration of the test substance in polyethylene glycol. Erythema, necrosis and diameter of effects were recorded 24 and 48 hours later.
- Epidermal applications: The intradermally injected animal was also treated epidermally with approximately 0.5 ml of a 50% (w/w) concentration of the test substance in vaseline. The treated skin was assessed for erythema and oedema 24 and 48 hours after bandage removal.
Four other animals were exposed to 0.05 ml of a 50 %, 25 %, 10 % and 5 % (w/w) concentration of the test substance in vaseline, occlusively. The reaction sites were assessed for erythema and oedema 24 and 48 hours after bandage removal.
MAIN STUDY:
- Doses were chosen based on a preliminary study.
A. INDUCTION EXPOSURE
- Day of induction: Day 1 (intradermal injection); Day 8 (epidermal)
On day 7, approximately 24 hours prior to the epidermal induction application, the scapular area was pretreated with 10 % Sodium-Dodecyl-Sulfate (SDS) in vaseline. The SDS was massaged into the skin with a spatula without bandaging. This concentration of SDS enhances sensitisation by provoking a mild inflammatory reaction.
- Site: clipped area of the dorsal skin from the scapular region
- No. of exposures: 3 pairs (intradermal injection); 3 (epidermal)
- Exposure period: Once (intradermal injection); 48h (epidermal)
- Test groups: 5% (w/w) in polyethylene glycol (intradermal injection); 50% (w/w) in vaseline (epidermal)
- Control group: Freunds' Complete Adjuvant 50:50 with distilled water; polyethylene glycol (intradermal injection); vaseline (epidermal)
- Evaluation: Reaction sites were, assessed for erythema and oedema immediately after removal of the dressings.
B. CHALLENGE EXPOSURE
- Day of challenge: Two weeks after the epidermal induction application
- No. of exposures: Test and control guinea pigs
- Exposure period: 24h (the dressings and residual test substance were removed using a moistened tissue)
- Test groups: 10, 25, 50% (w/w) in vaseline
- Control group: Vaseline
- Site: 5 x 5 cm clipped area on the left flank of each guinea pig
- Evaluation (hr after challenge): 24 and 48 h (the sites were assessed for redness and swelling)
- Observations: Mortality/Viabillty/Toxicity (once daily); body weights (during acclimatisation and at termination of the study)
- Histopathology: All animals were sacrificed after the termination of observation by carbon dioxide asphyxiation. Immediately thereafter, the four challenge treated skin areas of the last challenge were cut using a surgical scissor. Each skin site was collected in a coded, perforated small cassette and per animal fixed in neutral phosphate buffered 4% formaldehyde solution. Sections were cut from the skin sites of experimental and control animals treated with the highest test substance concentration and with the vehicle. The sections were stained with haematoxylin and eosin. At least one section from each skin site was microscopically examined by a pathologist. No microscopically examination was performed on the skin sites treated with the intermediate concentrations of experimental and control animals. - Challenge controls:
- vehicle
- Positive control substance(s):
- yes
- Remarks:
- Formaldehyde (A positive control experiment is carried out once a year as a sensitivity check of the test system. The most recent test was carried out in April 1991.)
Results and discussion
- Positive control results:
- Clearly positive results were observed in the experimental animals after the challenge with 0.2% (w/w) FORMALDEHYDE in distilled water.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 (vehicle only)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 (vehicle only)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10, 25, 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10, 25, 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Histopathological examination revealed no treatment related differences between the 50% test substance concentration treated- and control-skin areas in both experimental and control animals.
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
TOXICITY SYMPTOMS / MORTALITY:
No symptoms of systemic toxicity were observed in the animals of the main study and no mortality occurred during the preliminary- and main-study.
BODY WEIGHTS:
The average body weight gain of experimental and control animals was considered to be similar.
CHALLENGE:
No skin reactions were evident in response to any of the test substance concentrations and the vehicle control. However, many challenge-sites were difficult to score due to red staining of the skin by the test substance.
HISTOPATHOLOGY
CONTROL GROUP:
- 50% concentration: infiltrates of mononuclear cells in all animals and acanthosis and parakeratosis in some animals.
- Vaseline (vehicle): infiltrates of mononuclear cells in the majority of animals and very slight acanthosis in some animals.
EXPERIMENTAL GROUP:
- 50% concentration: infiltrates of mononuclear cells in the majority of animals and acanthosis and parakeratosis in some animals.
- Vaseline (vehicle): infiltrates of mononuclear cells in the majority of animals and acanthosis and parakeratosis in some animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions of this study, the test substance is considered not skin sensitizing.
- Executive summary:
In order to assess the cutaneous allergenic potential of the test substance (purity 97.5%), a Maximisation Test was performed in 30 (20 test and 10 control) female albino guinea pigs, in accordance with OECD Guideline 406 and GLP. Test substance concentrations selected for the main study were based on the results of a preliminary study. In the main study, animals were intradermally injected with 5% test substance concentration in polyethylene glycol (PEG) on day 1. On day 7 all animals were treated with 10% SDS, followed by epidermal exposure to a 50% concentration of the test substance in vaseline 24 h later. Control animals were similarly treated with each vehicle alone. Two weeks after the epidermal application (induction), all animals were challenged by epidermal exposure to a semiocclusive dressing with the test substance in vaseline (vehicle) at concentrations of 10, 25 and 50% (w/w) and the vehicle control, respectively. The challenge reactions were assessed 24 and 48 hours after bandage removal. The epidermal exposure to the test substance in the challenge phase did not result in positive sensitisation reactions in response to any of the test substance concentrations and the vehicle, respectively. Red staining was observed at the test substance treated skin sites, which made scoring of erythema difficult. Therefore, treated skin was evaluated by histopathology for infiltration of immune cells. Histopathological examination revealed no treatment related differences between the 50% test substance concentration treated- and control-skin areas in both experimental and control animals. Moreover, no differences were found in the microscopical findings between experimental and control animals. From these results it was concluded that no sensitisation was induced by the test substance.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.