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Diss Factsheets
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EC number: 201-607-5 | CAS number: 85-44-9
- 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
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: No solvent control, details of the reading not given, number of animals not given, poor documentation
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Comparison of local lymph node assay with the guinea-pig maximization test for the detection of a range of contact allergens
- Author:
- Basketter DA, Scholes EW (1992). Comparison of local lymph node assay with the guinea-pig maximization test for the detection of a range of contact allergens. Fd. Chem. Toxicol. 30, 65-69.
- Year:
- 1 992
- Bibliographic source:
- Fd. Chem. Toxicol. 30, 65-69.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- Guinea pigs were treated by a series of 6 intradermal injections in the shoulder region to induce sensitization. After 6-8 days, sensitization was boosted by a 48 h occluded patch placed over the injection site. 12-14 days later, the animals were challenged on the flank by a 24 h occluded patch at the maximum non-irritant concentration. Challenge sites were scored for erythema and edema 24 and 48 h after removal of the patches
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Published study (1992). At this time an OECD guideline for a LLNA was not available.
Test material
- Reference substance name:
- Phthalic anhydride
- EC Number:
- 201-607-5
- EC Name:
- Phthalic anhydride
- Cas Number:
- 85-44-9
- Molecular formula:
- C8H4O3
- IUPAC Name:
- 1,3-dihydro-2-benzofuran-1,3-dione
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- not specified
- Details on test animals and environmental conditions:
- no data
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: acetone /polyethylene glycol 400 = 70:30
- Concentration / amount:
- induction injection: 0.1%
induction patch: 25%
challenge patch: 10%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: acetone /polyethylene glycol 400 = 70:30
- Concentration / amount:
- induction injection: 0.1%
induction patch: 25%
challenge patch: 10%
- No. of animals per dose:
- no data
- Details on study design:
- 1st application: Induction 0.1 % intracutaneous
2nd application: Induction 25 % occlusive epicutaneous
3rd application: Challenge 10 % occlusive epicutaneous
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: Not specified
- Group:
- test chemical
- Dose level:
- Not specified
- Remarks on result:
- other: 90 % of the tested guinea pigs were judged to be positive. Classification: extreme sensitizing (no further details given)
- Reading:
- other: Not specified
- Group:
- negative control
- Remarks on result:
- other: Dextran, 10% in challenge experiment
- Reading:
- other: Not specified
- Group:
- positive control
- Remarks on result:
- other: m-Aminophenol, 5% in challenge
Any other information on results incl. tables
90 % of the tested guinea pigs were judged to be positive. Classification: extreme sensitizing (no further details given).
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Executive summary:
Guinea pigs were treated by a series of 6 intradermal injections in the shoulder region to induce sensitization. After 6-8 days, sensitization was boosted by a 48 h occluded patch placed over the injection site. 12-14 days later, the animals were challenged on the flank by a 24 h occluded patch at the maximum non-irritant concentration. Challenge sites were scored for erythema and edema 24 and 48 h after removal of the patches. 90% of the animals were judged to be positive, resulting in the overall assessment of extremely sensitizing.
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.
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