Registration Dossier
Registration Dossier
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EC number: 217-110-1 | CAS number: 1742-95-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: data from OECD SIDS report
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- SIDS Initial Assessment Report for Phthalimide
- Author:
- OECD SIDS
- Year:
- 2 005
- Bibliographic source:
- SIDS Initial Assessment Report For SIAM 20, 19-22 April 2005
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- To determine the eye irritation potential of phthalimide in rabbits
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Phthalimide
- EC Number:
- 201-603-3
- EC Name:
- Phthalimide
- Cas Number:
- 85-41-6
- IUPAC Name:
- 1H-isoindole-1,3(2H)-dione
- Reference substance name:
- 1H-Isoindole-1,3 (2H)-dione
- IUPAC Name:
- 1H-Isoindole-1,3 (2H)-dione
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Phthalimide
- Molecular formula : C8H5NO2
- Molecular weight : 147.13 g/mol
- Substance type: Organic
- Physical state: Solid
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- 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 was instilled into the conjunctival sac
- Duration of treatment / exposure:
- no data
- Observation period (in vivo):
- no data
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- no data
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: no data
- Score:
- 0
- Remarks on result:
- other: no irritation observed
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No irritation was observed when the phthalimide was instilled into the eyes of 2 rabbits.
Hence phthalimide can be considered as not irritating to eyes. - Executive summary:
A study was conducted to evaluate the eye irritation potential of phthalimide in rabbits.
50 mg of phthalimide was instilled into the conjunctival sac of 2 rabbits and signs of irritation were observed (duration not mentioned).
No irritation was observed when the phthalimide was instilled into the eyes of 2 rabbits.
Hence phthalimide can be considered as not irritating to eyes.
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