Registration Dossier

Administrative data

Endpoint:
eye irritation, other
Remarks:
OECD 405 included
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:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Qualifier:
according to
Guideline:
other: JMAFF guidelines (2000)
Principles of method if other than guideline:
not available
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

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.