Registration Dossier
Registration Dossier
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EC number: 214-604-9 | CAS number: 1163-19-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Performed prior to international guidelines. Accepted under the EU RAR (2002).
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 002
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Principles of method if other than guideline:
- consistent with current guidelines
- GLP compliance:
- yes
Test material
- Reference substance name:
- Bis(pentabromophenyl) ether
- EC Number:
- 214-604-9
- EC Name:
- Bis(pentabromophenyl) ether
- Cas Number:
- 1163-19-5
- Molecular formula:
- C12Br10O
- IUPAC Name:
- bis(pentabromophenyl) ether
- Details on test material:
- DE 83R commercial product
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 100 mg/rabbit
- Duration of treatment / exposure:
- once
- Observation period (in vivo):
- see below
- Number of animals or in vitro replicates:
- see below
- Details on study design:
- each animal served as its own control
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- other: all animals at all time points
- Time point:
- other: all
- Score:
- 0
- Max. score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- DecaBDE is not an eye irritant.
- Executive summary:
DecaBDe was instilled in the right eye of each of 6 rabbits. Observations were recorded at 1, 24, 48 and 72 hrs post treatment. No positive ocular scores were recorded over the course of the study. In consultation with the sponsor, the study was terminated at 72 hours. Based on the observations, DecaBDE is not an eye irritant.
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