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Diss Factsheets
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EC number: 204-171-4 | CAS number: 117-08-8
- 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 (LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented publication (OECD SIAP final draft)
Data source
Referenceopen allclose all
- 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 D.A., Scholes E.W.
- Year:
- 1 992
- Bibliographic source:
- Fd. Chem. Toxicol. 30, 65, 1992
- Reference Type:
- secondary source
- Title:
- SIAR for phthalic anhydride, CAS-No. 85-44-9.
- Author:
- OECD SIDS
- Year:
- 2 005
- Bibliographic source:
- SIAM 20, Final draft, 19-21 Apr 2005.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Principles of method if other than guideline:
- The LLNA was performed similar to OECD guideline 429. Groups of 4 CBA/Ca mice (males and females, age of 8-12 weeks) were treated by daily topical application of 25 µl solution containing 2.5, 5 and 10 % TCPA in acetone/olive oil for 3 consecutive days. 4-5 days after the first topical application all mice were injected with radiolabelled 3H-methylthymidine (3HTdR) via tail vein. After 5 hours the mice were killed and the draining auricular lymph nodes were excised and pooled for each group. A single cell suspension of lymph node cells was prepared and 3HTdR incorporation was measured by ß-scintillation counting.
- GLP compliance:
- not specified
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Phthalic anhydride
- EC Number:
- 201-607-5
- EC Name:
- Phthalic anhydride
- Cas Number:
- 85-44-9
- IUPAC Name:
- 2-benzofuran-1,3-dione
- Details on test material:
- - Name of test material (as cited in study report): Phthalic anhydride
- Analytical purity: > 98%
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 8-12 weeks
Study design: in vivo (LLNA)
- Vehicle:
- other: acetone polyethylene glycol 400 (70:30, v/v)
- Concentration:
- 2.5, 5 and 10 %
- No. of animals per dose:
- 4
- Details on study design:
- MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response: The chemical was regarded as a sensitizer if at least one concentration of the chemical resulted in a threefold or greater increase of labelled thymidine incorporation compared with control values.
TREATMENT PREPARATION AND ADMINISTRATION: Animals were treated by daily topical application of 25 ul solution containing 2.5, 5, 10 % phthalic anhydride in acetone/olive oil for 3 consecutive days. Control mice were treated with the vehicle alone. 4-5 days after the first topical application all mice were injected with radiolabelled 3H-methylthymidine (3HTdR) via tail vein. After 5 hours the mice were killed and the draining auricular lymph nodes were excised and pooled for each group. A single cell suspension of lymph node cells (LNC) were prepared. 3HTdR incorporation was measured by ß-scintillation counting. The proliferative response of LNC was expressed as radioactive disintegrations per min per lymph node (dpm/node), and as the ratio 3HTdR incorporation into LNC of test nodes relative to that recorded for control nodes (test/control ratio). - Positive control substance(s):
- mercaptobenzothiazole (CAS No 149-30-4)
Results and discussion
In vivo (LLNA)
Results
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Ratio of test to control lymphocyte proliferation in 2.5, 5 and 10 % TCPA were 26, 21.5 and 20.9, respectively. No further data.
Any other information on results incl. tables
Based on the results, the test substance can be classified as a potent skin sensitizer (R43/Cat 1 according to EU/GHS standards).
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
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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