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EC number: 219-348-1 | CAS number: 2421-28-5
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: experimental result in a reliable toxicology laboratory, preceding establishment of guideline and GLP. Documentation is limited.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 969
- Report date:
- 1969
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- no notation of adjuvant; challenge exposure was administered via intradermal injection.
- GLP compliance:
- no
- Remarks:
- precedes establishment of GLP
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The described guinea pig sensitisation test similar to OECD 406 was conducted in 1977 before the guidance for the LLNA (OECD429, first adopted in 2002) was available, and before the method was fully established and validated. And since the result of the non-LLNA test is considered to be scientifically valid, the test was not repeated also taking into account exposure and animal welfare considerations.
Test material
- Reference substance name:
- Benzophenone-3,3':4,4'-tetracarboxylic dianhydride
- EC Number:
- 219-348-1
- EC Name:
- Benzophenone-3,3':4,4'-tetracarboxylic dianhydride
- Cas Number:
- 2421-28-5
- Molecular formula:
- C17H6O7
- IUPAC Name:
- 5-(1,3-dioxo-1,3-dihydro-2-benzofuran-5-carbonyl)-1,3-dihydro-2-benzofuran-1,3-dione
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- no data
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.4 mg over 8 administrations, 0.1% solution (w/v) of BTDA crystalline powder in normal saline.
- Day(s)/duration:
- every other day
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.4 mg over 8 administrations, 0.1% solution (w/v) of BTDA crystalline powder in normal saline.
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 36
- Details on study design:
- The study was undertaken with unwashed, commercial grade BTDA, and also with BTDA washed with acetone. Eighteen guinea pigs received intradermal injections (0.05 ml of 0.1% BTDA unwashed w/v in saline, without adjuvant) every other day for 8 injections. They were allowed a rest period of 3 weeks, after which they received a single challenge dose by intradermal injection. The experiment was repeated with BTDA purified by washing in acetone.
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Group:
- other: unwashed BTDA
- Dose level:
- 0.1%
- No. with + reactions:
- 15
- Total no. in group:
- 18
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Group:
- other: acetone-washed BTDA
- Dose level:
- 0.1%
- No. with + reactions:
- 17
- Total no. in group:
- 18
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Conclusions:
- 1,3-Isobenzofurandione, 5,5'-carbonylbis- (BTDA) was purified by washing in acetone, and commercial-grade (unwashed) and purified BTDA was tested in a non-LLNA skin sensitisation test in guinea pigs. Both the unwashed and washed substance were found to be sensitising in the guinea pig.
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