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Registration Dossier
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EC number: 203-570-0 | CAS number: 108-30-5
- 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

Dermal absorption
Administrative data
- Endpoint:
- dermal absorption
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- Not specified
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Cyclic acid anhydrides: Human health aspects
- Author:
- World Health Organization (WHO)
- Year:
- 2 009
- Bibliographic source:
- Concise International Chemical Assessment Document 75
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- No method details - three human volunteers had hexahydrophthalic anhydride applied to the dorsum for 48 hours. No details of occlusion are provided. The material was dispersed in petrolatum. Percutaneous absorption was estimated from urinary excretion measurements
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Cyclohexane-1,2-dicarboxylic anhydride
- EC Number:
- 201-604-9
- EC Name:
- Cyclohexane-1,2-dicarboxylic anhydride
- Cas Number:
- 85-42-7
- Molecular formula:
- C8H10O3
- IUPAC Name:
- 3a,4,5,6,7,7a-hexahydro-2-benzofuran-1,3-dione
- Details on test material:
- No details available
Constituent 1
- Specific details on test material used for the study:
- The CICAD data are presented for a variety of cyclic acid anhydrides. Succinic anhydride is part of the general group addressed although studies with succcinic anhydride are not specifically included. Read across from group information is considered appropriate for members of the acid anhydride family, given the close structural similarities and physico-chemical similarities.
- Radiolabelling:
- no
Test animals
- Species:
- human
- Details on test animals or test system and environmental conditions:
- No information - three volunteers exposed for 48 hours but no further details on experimental conditions
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- petrolatum
- Duration of exposure:
- 48 hours
- Doses:
- Not specified
- No. of animals per group:
- Three human volunteers
- Control animals:
- no
- Details on study design:
- Hexahydrophthalic anhydride was applied to the dorsal skin of three human volunteers for 48 hours. Urine was collected from the volunteers for 72 hours and analyzed for the hydrolysis product, hexahydrophthalic acid.
- Details on in vitro test system (if applicable):
- Not applicable
Results and discussion
- Signs and symptoms of toxicity:
- not specified
- Dermal irritation:
- yes
- Remarks:
- Slight erythema noted for subject with highest excretion, suggesting inflamed skin allowed greater penetration
- Absorption in different matrices:
- The excreted amounts of hexahydrophthalic acid were between 1.4% and 4.5%, 0.2% and 1.3%, and 0% and 0.4% of the total applied dose for the three subjects, respectively.
- Total recovery:
- No details
- Conversion factor human vs. animal skin:
- Insufficient information to estimate a conversion factor
Applicant's summary and conclusion
- Conclusions:
- This review supports the conclusion that hexahydrophthalic anhydride is minimally absorbed following dermal exposure. Cyclic anhydrides share structural and physicochemical properties such that toxicokinetic data on hexahydrophthalic anhydride can be used for read-across to succinic anhydride. The hydrolysis product of succinic anhydride is succinic acid, an endogenous substance and food ingredient, that is expected to show minimal absorption by the dermal route. A separate percutaneous absorption study on succinic anhydride is not proposed and cannot be justified based upon animal welfare considerations.
- Executive summary:
The percutaneous absorption of hexahydrophthalic anhydride was very low following application to the skin of three human volunteers. Cyclic anhydrides, such as hexahydrophthalic acid, are readily hydrolyzed to the corresponding dicarboxylic acids and the excreted amounts of hexahydrophthalic acid in the three volunteers were between 0% and 4.5% of the total applied dose. The subject with the highest excretion showed mild skin effects which suggested that inflamed skin may permit higher dermal absorption.
Cyclic anhydrides share structural and physicochemical properties such that toxicokinetic data on hexahydrophthalic anhydride can be used to read-across to succinic anhydride. The hydrolysis product of succinic anhydride is succinic acid, an endogenous substance and food ingredient, that is expected to show minimal absorption by the dermal route. A separate percutaneous absorption study on succinic anhydride is not proposed and cannot be justified based upon animal welfare considerations.
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