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EC number: 619-817-4 | CAS number: 52671-72-4
- 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: Test performed prior to the implementation of the current acknowledged OECD testing and GLP guidelines . The test was conducted according to the method of Magnusson and Kligman.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Magnusson & Kligman
- GLP compliance:
- no
- Remarks:
- pre-guideline study
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 2,4-dioxo-3-oxatricyclo[7.3.1.0⁵,¹³]trideca-1(13),5,7,9,11-pentaene-8,10-dicarboxylic acid
- EC Number:
- 619-817-4
- Cas Number:
- 52671-72-4
- Molecular formula:
- C14H6O7
- IUPAC Name:
- 2,4-dioxo-3-oxatricyclo[7.3.1.0⁵,¹³]trideca-1(13),5,7,9,11-pentaene-8,10-dicarboxylic acid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright-White
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
-Strain specifics: Hoe: DHPK (SPFLac)
- Source: Hoechst AG, breeding colony
- Weight at study initiation: mean 332 g (range: 240-580 g)
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: Freund's Adjuvant
- Concentration / amount:
- INDUCTION EXPOSURE: 500 mg test item was mixed with 10 mL Freund's Adjuvant
0.05 mL were injected respectively
CHALLENGE EXPOSURE: 0.5 % in 2 % starch mucilage (non-irritant concentration determined in pilot test and preliminary patch test)
0.5 mL were administered via patch (occlusive) respectively
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Freund's Adjuvant
- Concentration / amount:
- INDUCTION EXPOSURE: 500 mg test item was mixed with 10 mL Freund's Adjuvant
0.05 mL were injected respectively
CHALLENGE EXPOSURE: 0.5 % in 2 % starch mucilage (non-irritant concentration determined in pilot test and preliminary patch test)
0.5 mL were administered via patch (occlusive) respectively
- No. of animals per dose:
- PILOT TEST (for determination of a primary non-irritant concentration range):
6 concentrations / 1 animal per concentration
PRELIMINARY PATCH TEST (for determination of a primary non-irritant concentration for challenge exposure):
5 concentrations / 1 animal per concentration
MAIN STUDY:
1 concentration / 15 animals per concentration - Details on study design:
- RANGE FINDING TESTS:
PILOT TEST for determination of a primary non-irritant concentration range:
test item concentrations in 2 % starch mucilage: 40 %, 20 %, 10 %, 5 %, 1 %, 0.1 %
0.5 mL were administered to the shaved flank respectively
PRELIMINARY PATCH TEST determination of a primary non-irritant concentration for challenge exposure:
test item concentrations in 2 % starch mucilage: 8 %, 5 %, 3 %, 1 %, 0.5 %
0.5 mL were administered via patch respectively
MAIN STUDY:
A. INDUCTION EXPOSURE
- No. of exposures: 10 intradermal injections within 14 days
- Exposure period: 15 days without treament
- Site: shaved flank measuring about 30 cm^2 for intradermal injections
- Concentrations: see above
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 28 of study
- Site: untreated flank
- Concentrations: primary non irritent concentration of 0.5% according to the PRELIMINARY PATCH TEST
- Evaluation (hr after challenge): 24 h, 48 h and 72 h - Challenge controls:
- no controls reported
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other:
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 %
- No. with + reactions:
- 15
- Total no. in group:
- 15
- Clinical observations:
- distinct erythema
- Remarks on result:
- other: Reading: other:. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5 %. No with. + reactions: 15.0. Total no. in groups: 15.0. Clinical observations: distinct erythema.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 %
- No. with + reactions:
- 13
- Total no. in group:
- 15
- Clinical observations:
- slight or distinct erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5 %. No with. + reactions: 13.0. Total no. in groups: 15.0. Clinical observations: slight or distinct erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 0.5 %
- No. with + reactions:
- 6
- Total no. in group:
- 15
- Clinical observations:
- slight erythema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 0.5 %. No with. + reactions: 6.0. Total no. in groups: 15.0. Clinical observations: slight erythema.
Any other information on results incl. tables
During the induction exposure intradermal injections with a mixture of 500 mg test substance + 10 ml Freund's adjuvant caused severe erythema at the entire flanks as well as injection site necrosis in all animals within 8 days. Lesions partly healed, but erythema persisted until the end of the subsequent 15 days rest period.
For the challenge exposure 0.5 % test substance in 2 % starch mucilage were administered via patch/occlusive bandage to the untreated flanks respectively. All animals showed distinct erythema after 24 h. 48 h p.a. slight or distinct erythema were observed in 13 animals, 72 h p.a. slight erythema were still present in 6 animals.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- In a guinea pig maximisation test according to the method of Magnusson and Kligman, the test item caused distinct skin reactions in all 15 animals of the treatment group after challenge exposures. Based on the results of this study the test item showed some evidence for sensitising properties although the reliablity is restricted by missing positive and negative controls.
- Executive summary:
Testing for sensitizing properties of the test item was performed in 15 male guinea pigs according to the method of Magnusson & Kligman. Intradermal induction was performed using 5 % test item preparation in Freund's adjuvant. Within 8 days of the induction exposure severe erythema and injection sites necroses were recorded in all animals. After a rest period of 15 days challenge treatment was carried out with 0.5 % test item in 2 % starch mucilage. The challenge treatment caused distinct erythema in all 15 animals of the treatment group after 24 h. Slight erythema were still present in 6 animals 72 h p.a.
Therefore the test substance was considered to be a skin sensitiser, category 1 according to regulation (EC) No 1272/2008.
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