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EC number: 613-407-9 | CAS number: 63948-88-9
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014-2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- other: limit test
- Limit test:
- yes
Test material
- Reference substance name:
- 5-Isobenzofurancarboxylic acid, 1,3-dihydro-1,3-dioxo-, reaction products with 1,2-propanediol
- EC Number:
- 613-407-9
- Cas Number:
- 63948-88-9
- Molecular formula:
- not applicable
- IUPAC Name:
- 5-Isobenzofurancarboxylic acid, 1,3-dihydro-1,3-dioxo-, reaction products with 1,2-propanediol
- Reference substance name:
- ZAN 573
- IUPAC Name:
- ZAN 573
- Test material form:
- solid: particulate/powder
- Details on test material:
- Product name: ZAN 573, 100% purity (UVCB)
Chemical name: 5-Isobenzofurancarboxylic acid, 1,3-dihydro-1,3-dioxo-,
polymer with 1,2-propanediol (85%) and Trimellitic anhydride (15%)
CAS numbers : 63948-88-9: 85% and 552-30-7: 15%
Batch number: 130072591
Appearance: Yellow to brown solid, coarse powder
Purity: treated as 100% (for more details see above)
Manufacturing date: 24 January 2014
Expiry date: 24 January 2016
Storage conditions: Controlled room temperature (15-25°C, below 70 RH%)
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:CRL, RMS Germany Gmbh, Sandhofer Weg 7, D-97633 Sulzfeld.
- Age at study initiation:
- Weight at study initiation: males 221-251 g, females: 208-236 g.
- Fasting period before study: no data
- Diet (e.g. ad libitum): ssniff® SM R/M "Autoclavable complete diet for rats and mice – breeding and maintenance". ssniff Spezialdiäten GmbH, D-59494 Soest Germany (Batch no.: 190 1786, expiry date: January 2015), ad libitum,
- Water): tap water from the municipal supply, ad libitum.
- Acclimation period: 6 days
- Housing: Individual caging
- Cage type: Type II. polypropylene/polycarbonate
- Bedding: Lignocel Bedding for Laboratory Animals was available to animals during the study.
- Light: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
- Temperature: 20.5 – 25.0 °C
- Relative humidity: 42 – 68 %
- Ventilation: 15-20 air exchanges/hour
- Enrichment: Rodents were housed with deep wood sawdust bedding to allow digging and other normal rodent activities.
IN-LIFE DATES: From:15 October 2014 To: 29 Oct 2014.
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: once per day
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight.
The back of each animal was shaved (approximately 10 % area of the total body surface) approximately 24 hours prior to treatment. The test item was applied as a single dose as supplied to the shaved skin and remained in contact with the skin for the 24-hour exposure period. A sufficient amount of water was used to dampen the test material to ensure good contact with the skin. Sterile gauze pads were placed on the skin of rats to cover the test item. These gauze pads were kept in contact with the skin by a patch with adhesive hypoallergenic plaster. The entire trunk of the animal was then wrapped with semi occlusive plastic wrap for 24 hours.
At the end of the exposure period, the area of skin treated with the test item was washed with water of body temperature.
Macroscopic examination was performed on all animals. All animals were anaesthetised with Euthasol® 40 % (details in 3.1.3.) and exsanguinated. After examination of the external appearance, the cranial, thoracic and abdominal cavities were opened and the appearance of the tissues and organs was observed. All macroscopic changes were recorded. - Statistics:
- none
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No deaths observed
- Mortality:
- no deaths
- Clinical signs:
- other: Erosion of the skin with crust formation: 2/5 males, 1/5 females Oedema of the skin: 1/5 males, 1/5 females Erythema in 1/5 females
- Gross pathology:
- No adverse effects were seen which are attributable to test material exposure.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- In an acute dermal toxicity test in Wistar rats, the LD50 of ZAN 573 was greater than 2000 mg/kg bw. The substance is not classified according to EU Regulation No. 1272/2008.
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