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Diss Factsheets
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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
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Endpoint summary
Administrative data
Description of key information
The substance is subject to EC harmonization (Index No. 607-100-00-9); thus it will be classified according to Regulation EC no. 1272/2008 as an eye irritant, Category 2, and respiratory irritant, STOT-SE, Category 3.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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:
- other: guideline study, precedes establishment of GLP. Documentation is limited.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: 16 CFR 1500.41, Federal Hazardous Substances Act, USA
- Deviations:
- no
- Principles of method if other than guideline:
- Dermal exposure to intact and abraded skin of rabbits under occlusive patch for 24 hours, with an observation period of 72 hours after application.
- GLP compliance:
- no
- Remarks:
- preceeds establishment of GLP
- Species:
- rabbit
- Strain:
- other: albino
- Details on test animals or test system and environmental conditions:
- male and female.
Animals were housed individually in metal cages suspended above the droppings.
Food and water were available ad libitum. - Type of coverage:
- occlusive
- Preparation of test site:
- other: intact and abraded
- Vehicle:
- other: 25% ethanol
- Controls:
- no
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 24 hour exposure
- Observation period:
- 72 hours after administration of material
- Number of animals:
- 6 each, abraded and intact skin
- Details on study design:
- The skin of each rabbit was prepared for treatment by prior close clipping of the hair with an electric clipper. The skin of rabbits in one of the two groups was abraded by producing shallow incisions with a scalpel blade over an area of skin measuring one inch by one inch.
The paste was applied to a rubber dental dam and placed in contact with the prepared abdominal skin of each rabbit. Adhesive tape was placed over the dental dam and the entire abdomen was wrapped with an elastic bandage to insure constant contact of the compound for a 24-hour period.
At the end of the 24 hour period of drug contact, and at 48 and 72 hours, the bandages were removed and the skin reactions were graded. - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24
- Score:
- 0
- Max. score:
- 8
- Remarks on result:
- other: Duration of exposure was 24 hours.
- Irritant / corrosive response data:
- BTDA did not produce any irritating properties when applied to the skin of rabbits.
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- 1,3-Isobenzofurandione, 5,5'-carbonylbis- (BTDA) was tested for skin irritation in the intact and abraded skin of albino rabbits, under occlusive conditions, for 24 hours. The results indicate the substance is not irritating.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: guideline study; precedes establishment of GLP. Documentation is limited.
- Qualifier:
- according to guideline
- Guideline:
- other: 16 CFR 1500.42, Federal Hazardous Substances Act, USA
- Principles of method if other than guideline:
- Test material is placed in one eye of six albino rabbits, and the eyes are examined and graded for ocular irritation 24, 48 and 72 hours after administration.
- GLP compliance:
- no
- Remarks:
- preceeds establishment of GLP
- Species:
- rabbit
- Strain:
- other: albino
- Details on test animals or tissues and environmental conditions:
- male and female.
Individually housed in metal cages suspended above the droppings.
Food and water were available ad libitum. - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 3 mg applied to one eye.
- Duration of treatment / exposure:
- 7 days.
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- The untreated eye of each rabbit served as the control. Prior to application of the compound and again at the termination of the 7-day observation period, the eyes of each animal were examined with the use of 2% sodium fluorescein and a small-window ultraviolet, quartz, mercury pencil lamp. Other observations for eye irritation were made frequently on the day of application and again at 24, 48 and 72 hours, and at 4 and 7 days thereafter. Eye irritation was graded and recorded according the method of Draize in "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics", 1959.
The treated eye was not washed. - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 h and later
- Score:
- 0.1
- Max. score:
- 8
- Reversibility:
- fully reversible within: 24 h
- Irritant / corrosive response data:
- One rabbit showed mild irritation of the exposed eye one hour after instillation of the test material. This reaction appeared normal within 24 hours.
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- 1,3-Isobenzofurandione, 5,5'-carbonylbis- (BTDA) was tested for eye irritation in albino rabbits, and evaluated for up to 7 days. The results indicate the substance is not irritating.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
1,3-Isobenzofurandione, 5,5'-carbonylbis- (BTDA) was tested for eye and skin irritation in albino rabbits. The results indicate the substance is not irritating to either eye or skin. However, an EC harmonized classification exists for eye irritaton, Category 2, at concentrations greater than 1%. It is also classified as a respiratory irritant, Specific Target Organ Toxicity, single exposure, Category 3. Therefore, the substance is classified.
Justification for classification or non-classification
Experimental data indicates the substance has not demonstrated irritation to either eye or skin. However, as the substance is subject to EC harmonization (index # 607 -100 -00 -9), it will be classified according to the Regulation EC No. 1272/2008 as an eye irritant, Category 2, and Specific Target Organ Toxicity, single exposure, Category 3.
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.
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