Registration Dossier
Registration Dossier
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EC number: 253-057-0 | CAS number: 36483-57-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and appropriate guidelines
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF guidelines (2000)
- Principles of method if other than guideline:
- not available
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,2-dimethylpropan-1-ol, tribromo derivative
- EC Number:
- 253-057-0
- EC Name:
- 2,2-dimethylpropan-1-ol, tribromo derivative
- Cas Number:
- 36483-57-5
- Molecular formula:
- C5H9Br3O
- IUPAC Name:
- 3-bromo-2,2-bis(bromomethyl)propan-1-ol
- Details on test material:
- Identification: FR-513
Mol. formula: C5H9Br3O
Mol. Weight: 324.92
CAS #: 36483-57-5
Description: White flakes
Batch: 039084 (taken from label)
Composition: Tribromoneopentyl alchohol 97%, Dibromoneopentyl glycol < 0.1%
Storage: At room temperature in the dark
Stability under storage conditions: Stable
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Albino Rabbit , New Zealand White (SPF-Quality)
Source: Charles River Deutschland, Kisslegg, Germany
Number of animals: 3 males
Age and body weight: at least 6 weeks old and body weights were at least 1.0 kg.
Housing: Individually in labelled cages with perforated floors.
Acclimatisation: at least 5 days before start of treatment under laboratory conditions.
Diet: Standard laboratory diet
Water: Free access to tap water
Temperature (°C): 21.0 ± 3.0 °C (actual range:16.7-22.3°C)
Humidity (%): 30-70% (actual range 33-74%)
Air changes (per hr): 15
Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: non treated eye serves as control
- Amount / concentration applied:
- 84.6, 84.8 or 84.7 mg (a volume of approx 0.1 ml)
- Duration of treatment / exposure:
- exposure to test material 1 second.
- Observation period (in vivo):
- 1, 24, 48 and 72 hr and 7, 14/21 days after instillation of the test substance.
Mortality/viability: Twice daily
Toxicity: At least once daily
Body weight: Day of treatment (prior to instillation) and at termination - Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- See attached document on scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal #1
- Time point:
- other: 1hr-14d
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal #2
- Time point:
- other: 1hr-21d
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal #3
- Time point:
- other: 1hr-21d
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 21 d
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 1hr-14d
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 1hr-21d
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hr
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 1hr-21d
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hr
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- other: 1hr-14d
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- other: 1hr-21d
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- other: 1hr-21d
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 1hr-14d
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 1hr-21d
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 1hr-21d
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritant / corrosive response data:
- see attached document on results
- Other effects:
- see attached document on results
Applicant's summary and conclusion
- Interpretation of results:
- highly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- FR-513 was found to have effects on the eyes of the rabbits which completely resolved after 7 or 14 days in two animals. In one animal some of the effects persisted until 21 d (the maximal observation period).
- Executive summary:
FR-513 was instilled into the test eyes of 3 NZ white rabbits at a dose of 84.6, 84.8 or 84.7 mg. Each eye was held closed for approx. 1 sec after administration. Observations were made 1, 24, 48 and 72 hours and 7, 14 and/or 21 after instillation.
Under the conditions of the study FR-513 was found to have effects on the eyes of the rabbits, which completely resolved after 7 or 14 days in two animals.
In one animal some of the effects persisted until 21 days (maximum observation period)
Based on the study results, FR-513 is classified as irritating to eyes in the EU.
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