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EC number: 204-255-0 | CAS number: 118-48-9
- 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
- Study period:
- 1990-07-10 to 1990-08-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- June 1989
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The guinea pig test was performed in 1989. At that time, a LLNA guideline was not available.
Test material
- Reference substance name:
- 4H-3,1-benzoxazine-2,4(1H)-dione
- EC Number:
- 204-255-0
- EC Name:
- 4H-3,1-benzoxazine-2,4(1H)-dione
- Cas Number:
- 118-48-9
- Molecular formula:
- C8H5NO3
- IUPAC Name:
- 4H-3,1-benzoxazine-2,4(1H)-dione
- Details on test material:
- - Name of test material (as cited in study report): Isatosäureanhydrid (Isatoic anhydride)
- Physical state: solid (powder, beige-brown)
- Analytical purity: 99.81% by HPLC (non-GLP)
- Impurities (identity and concentrations): no data
- Lot/batch No.: 05-0617
- Expiration date of the lot/batch: no data
- Stability under test conditions: yes
- Storage condition of test material: room temperature
No further data
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Lippische Versuchstierzucht, Hagemann GmbH & Co . KG, D-4923 Extertal 1, FRG
- Age at study initiation: no data
- Weight at study initiation: 270 - 326 g
- Housing: 5 per cage (Makrolon, type I V)
- Diet (ad libitum): Kliba 341.4 mm (Kaninchen-Meerschweinchen-Haltungsdiät), Klingentalmühle AG, CH-4303 Kaiseraugst, Switzerland
- Water (ad libitum): tap water, about 2 g of ascorbic acid per 10 L water was added to the drinking water twice a week
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 30-70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: no data
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- olive oil
- Concentration / amount:
- 5% intradermal induction
25 % epicutanoeus induction (occlusive)
10% challenge (occlusive)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- olive oil
- Concentration / amount:
- 5% intradermal induction
25 % epicutanoeus induction (occlusive)
10% challenge (occlusive)
- No. of animals per dose:
- 10 (test group)
5 (control groups 1 and 2) - Details on study design:
- RANGE FINDING TESTS:
- Amount applied: 2 x 2 cm filter paper strips containing the test material were applied to the skin of the flanks under an occlusive dressing. The animals were exposed to about 0.15 g of the test substance formulation.
- Exposure period: The test substance was applied 2 times for 24 hours within a period of 96 hours in order to detect non-specific phenomena that are not caused by a sensitization reaction but could possibly be attributed to a shift in the irritation threshold.
- Site of application: flank, respective on the same area
- Number of test animals: 4 per test concentration
- Readings: about 24 and 48 h after the beginning of application
MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal induction :
- 6 intradermal injections in groups of two per animal
- Injections for the test group:
A) front row: 2 injections each of 0.1 ml Freund's adjuvant without test substance emulsified with 0.9% aqueous NaCl-solution in a ratio of 1:1
B) middle row: 2 injections each of 0.1 ml of the test substance formulation
C) back row: 2 injections each of 0.1 ml Freund's adjuvant / 0.9 % aqueous NaCl-solution (1: 1) with test substance
- Injections for control groups 1 and 2: The animals were given the same injections (A, B, C) but without test substance, only with the formulating agent.
- Site of application: shoulder
- Readings: 24 h after the beginning of application
- Assessment of the skin findings: Draize scheme
- Application of the n-Dodecylsulphate sodium salt: Because of slight skin changes at the original injection sites these areas were treated with a 10% formulation of n-Dodecylsulphate sodium salt in white vaseline one day before the percutaneous induction.
Percutaneous induction:
- Percutaneous induction was carried out one week after intradermal induction
- Amount applied: 2 x 4 cm filter paper strips were applied to the skin of the shoulder under an occlusive dressing. The animals were exposed to about 0.3 g of the test substance formulation.
- The control groups were treated analogously to the test group but only with the solvent without the test substance.
- Duration of exposure: 48 hours
- Site of application: shoulder, same area as in the case of the previous intradermal application
- Readings: 48 h after the beginning of application
- Assessment of the skin findings: Draize scheme
B. CHALLENGE EXPOSURE
- Test concentration: non-irritant concentration
- Challenge 21 days after intradermal induction.
- Amount applied: 2 x 2 cm filter paper strips were applied to the skin of the flank under an occlusive dressing. The animals were exposed to about 0.15 g of the test substance formulation.
- Challenge: treatment of the test group and of control group 1 with the test substance formulation. Additionally olive oil DAB 9 was applied as a vehicle. Control group 2 only received olive oil DAB 9.
- Duration of exposure: 24 hours
- Site of application: intact clipped flank
- Readings: 24 and 48 h after the removal of the patch
- Assessment of the skin findings: Draize scheme - Challenge controls:
- no data
Study design: in vivo (LLNA)
- Statistics:
- no data
Results and discussion
- Positive control results:
- no data
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- scaling, superficial scabbing
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: scaling, superficial scabbing.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- vehicle control
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: vehicle control. No with. + reactions: 6.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- vehicle control
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: vehicle control. No with. + reactions: 4.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- vehicle control
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: vehicle control. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- vehicle control
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: vehicle control. No with. + reactions: 0.0. Total no. in groups: 5.0.
Any other information on results incl. tables
Induction findings:
After intradermal induction distinct erythema and edema were observed at the injection sites of the control and test animals, at which only Freund's adjuvant / saline (1:1) was applied. Injection of the test substance preparation in olive oil DAB 9 resp. in Freund's adjuvant / saline (1:1) caused distinct erythema and edema in the test animals. The control animals injected with olive oil DAB 9 (vehicle) showed distinct erythema .
After percutaneous induction incrustation, partially open (caused by the intradermal induction) in addition to distinct erythema and edema could be observed in the test animals. The animals of control group 1 and 2 which were injected with olive oil DAB 9 (vehicle) exhibited incrustation, partially open (caused by the intradermal induction) in addition to distinct erythema and edema.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- Classification: sensitizing
- Executive summary:
Report Summary
The substance Isatosäureanhydrid was tested for its sensitizing effect on the skin of the guinea pig in the maximization test based on the method of Magnusson and Kligman.
After intradermal induction distinct erythema and edema were observed at the injection sites of the control and test animals, at which only Freund's adjuvant / 0.9% aqueous NaCl-solution (1:1) was applied. Injection of the test substance preparation in olive oil DAB 9 resp. in Freund's adjuvant / 0.9 % aqueous NaCl-solution (1:1) caused distinct erythema and edema in the test animals. The control animals injected with olive oil DAB 9 (vehicle) showed distinct erythema.
After percutaneous induction incrustation, partially open (caused by the intradermal induction) in addition to distinct erythema and edema could be observed in the test animals. The animals of control group 1 and 2 which were injected with olive oil DAB 9 (vehicle) exhibited incrustation, partially open (caused by the intradermal induction) in addition to distinct erythema and edema.
The number of animals with skin findings after the challenge (21 days after intradermal induction) is summarized in the following table:
Challenge 10% in olive oil DAB 9 olive oil DAB 9 Control group 1 0/5 0/5 Control group 2 * no application of test substance 0/5 Test group 10/10 6/10 x/y: number of positive reactions/number of animals tested; readings 24 h after the removal of the patch
Control group 2 that had been intended for a potential 2nd challenge was not needed, since a 2nd challenge was not necessary on the basis of the unambiguous results of the 1st challenge.
After the challenge with the 10% test substance preparation in olive oil DAB 9 in 4 out of 10 test animals severe erythema in addition to slight edema could be observed. 6 out of 10 test animals showed distinct erythema. The animals of control group 1 did not show any skin reactions.
Olive oil DAB 9, which was applied as a vehicle caused slight erythema in 6 out of 10 test animals. Control group 1 and 2 did not show any skin reactions.
Under these test conditions and following the results described above Isatosäureanhydrid (i.e. isatoic anhydride) has a sensitizing effect on the skin of the guinea pig.
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