Registration Dossier
Registration Dossier
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EC number: 201-898-9 | CAS number: 89-32-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- other: cross reference to literature data
- Adequacy of study:
- weight of evidence
- Study period:
- not specified
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- Standard Draize Test
- Deviations:
- no
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Benzene-1,2:4,5-tetracarboxylic dianhydride
- EC Number:
- 201-898-9
- EC Name:
- Benzene-1,2:4,5-tetracarboxylic dianhydride
- Cas Number:
- 89-32-7
- Molecular formula:
- C10H2O6
- IUPAC Name:
- 5,11-dioxatricyclo[7.3.0.0³,⁷]dodeca-1,3(7),8-triene-4,6,10,12-tetrone
- Test material form:
- solid: crystalline
- Details on test material:
- - Colour: colourless
- Odour: odourless
- CAS-Number: 89-32-7
- Molecular formula: C10 H2 O6
- Molecular weight: 218.12
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- no data
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 50 mg
- Duration of treatment / exposure:
- 24 hours in standard draize test
- Observation period (in vivo):
- 24, 48 and 72 hours (up to 21 days) in strandard draize test
- Duration of post- treatment incubation (in vitro):
- no data
- Number of animals or in vitro replicates:
- no data
- Details on study design:
- no data
Results and discussion
In vivo
Results
- Irritation parameter:
- other: not specified
- Basis:
- other: not specified
- Time point:
- other: not specified
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- The substance was observed to cause severe eye irritation, leading to a classification as serious eye damage (Cat. 1).
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The substance needs to be considered as severe eye irritant, cat. 1.
- Executive summary:
Substance is listed in the consolidated version of EU Regulation 1272/2008 as corrosive, leading to a classification as serious eye damage (Cat. 1). The substance is highly reactive and hydrolyzes in contact with water or body fluids to the corresponding pyromellitic acid; measured ph-value of hydrolyzed material in water is 2. In literature, the substance is reported to be severly irritant to eyes in a standard Draize test, therefore it was decided to take over this classification and to conduct no further studies.
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