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Diss Factsheets
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EC number: 500-109-8 | CAS number: 43011-20-7
- 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:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 06 January 2015-05 March 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study under GLP
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 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 5-Isobenzofurancarboxylic acid, 1,3-dihydro-1,3-dioxo-, reaction products with 1,2-propanediol
- IUPAC Name:
- 5-Isobenzofurancarboxylic acid, 1,3-dihydro-1,3-dioxo-, reaction products with 1,2-propanediol
- Reference substance name:
- 5-Isobenzofurancarboxylic acid, 1,3-dihydro-1,3-dioxo-, polymer with 1,2-propanediol
- EC Number:
- 613-407-9
- Cas Number:
- 63948-88-9
- IUPAC Name:
- 5-Isobenzofurancarboxylic acid, 1,3-dihydro-1,3-dioxo-, polymer with 1,2-propanediol
- Reference substance name:
- ZAN 573
- IUPAC Name:
- ZAN 573
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Name: ZAN 573
Batch/Lot number:130072591
Description:Yellow to brown coarse powder
Molecular formula:C21H12O10
Molecular weight:424.314 g/mol
Purity:100%
Manufacture date:24 January 2014
Expiry date:24 January2016
Storage condition: Controlled room temperature (15-25°C, below 70 RH%)
Safety precautions:Routine safety precautions (gloves, goggles, face mask, lab coat) for unknown materials were applied to assure personnel health and safety
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Species and strain:New Zealand White rabbits
Source:S&K-LAP Kft.2173 Kartal, Császár út 135, HUNGARY
Justification of strain:The New Zealand White albino rabbit is one of the standard strains used for acute irritation toxicity studies.
Animal health:Only animals in acceptable health condition were used for the test.
Number of animals:3
Age of animals at treatment:~12 weeks old
Sex:Male
Body weight range at the beginning of the life phase: 3191-3823 g
at the end of the life phase: 3256-3925 g
Date of receipt: 30 December 2014
Acclimation time: 15days
Lighting periods; 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature range during the study: 20 ± 3 °C
Relative humidity during the study: 25-34 %
Housing/Enrichment: Rabbits were individually housed in AAALAC approved metal wire rabbit cages. Cages were of an open wire structure and cages were placed together to allow some social interaction with rabbit(s) in adjoining cages.
Ventilation: 15-20 air exchanges/hour
The animals received standard diet for rabbits produced by Cargill Takarmány Zrt., H- 5300 Karcag, Madarasi út, Hungary, ad libitum. Animals were provided with the following batch: Y 0550 11 14 0014, expiry date: 26 February 2015
Tap water was provided ad libitum.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- The test item was used as a single dose of 0.5 g, applied to the test area.
- Duration of treatment / exposure:
- Four hours after application, the test item was removed by gently washing with body temperature water.
- Observation period:
- Animals were examined for signs of erythema and oedema, and the responses scored at 60 minutes and then at 24, 48 and 72 hours after patch removal
- Number of animals:
- 3
- Details on study design:
- Approximately 24 hours prior to the test, the hair was clipped from the back and flanks of the animals. Removal of hair was performed in two steps. The majority of hair was clipped with an electronic hair clipper and the remaining hair was moistened with water and shaved with a razor.
The test item was applied to an approximately 6 cm² area of intact skin as follows:
• A single layer of a fine medical gauze (open-weave with large holes) of approximately 5x5 cm was placed over the application area,
• The appropriate amount of test item was carefully spread over the application area (the gauze helped maintain the test item in place),
• Three more layers of gauze were placed over the test item,
• These gauze patches were kept in contact with the skin by a patch of clear plastic with a surrounding adhesive hypoallergenic plaster to ensure continued good contact between the moistened test item and the shaved skin.
• The entire trunks of the animals were wrapped with plastic wrap for 4 hours.
• Medical elastic tubing was placed over the plastic to keep it in place.
Initially, a single animal was treated. As neither a corrosive effect nor a severe irritant effect were observed after the 1-hour observation, the test was completed using the 2 remaining animals with the same dose and an exposure period of 4 hours.
Four hours after application, the test item was removed by gently washing with body temperature water.
Animals were examined for signs of erythema and oedema, and the responses scored at 60 minutes and then at 24, 48 and 72 hours after patch removal.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 1
- Score:
- 0
- Max. score:
- 8
- Remarks on result:
- other: no irritation observed
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24
- Score:
- 0
- Max. score:
- 8
- Remarks on result:
- other: no irritation observed
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 48
- Score:
- 0
- Max. score:
- 8
- Remarks on result:
- other: no irritation observed
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 72
- Score:
- 0
- Max. score:
- 8
- Remarks on result:
- other: no irritation observed
- Irritant / corrosive response data:
- No irritation observed
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- ZAN 573 is not irritating to the skin of rabbits, according to OECD 404 testing. This study is informative for evaluation of the toxicity of members of the cyclic acid anhydride category, and is adequate for filling the data requirement for the registration of this substance. It is valid for hazard classification and risk assessment.
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