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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14-DEC-1999 to 22-MAR-2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This GLP-compliant study was conducted in accordance with OECD guideline 405 and EU method B.5.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Substance type: monoconstituent 
- Physical state: colourless liquid
- Analytical purity: 100%
- Density: 1.64
- Lot/batch No.: 6-99
- Manufacturing date: 24 May 1999
- Expiration date of the lot/batch: May 2001
- Storage condition of test material: at room temperature
Specific details on test material used for the study:
- Name of test material (as cited in study report): Perfluorosulfonyl vinyl-ether
- Purity: 100%
- Impurities, purity test date: no data available
- Physical state: colourless liquid
- Lot/batch No.: 6-99
- Manufacturing date: 24 May 1999
- Expiration date of the lot/batch: May 2001
- Storage condition of test material: at room temperature, away from humidity

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Conelli S.n.c. / Via Milano, 61 - 28041 ARONA (Novara) / ITALY
- Age at study initiation: 2-3 months old when received
- Weight at study initiation: 2.5-2.8 kg when received; on arrival at RBM, all animals were clinically observed and 20% of them were weighed: their weight conformed to that required.
- Housing: in the same room in which the treatment was performed; in metal cages with stainless steel feeders
- Diet: ad libitum with a diet coded "2 RB 15 GLP Certificate" (Charles River Italia's feed licensee Mucedola S.r.l., Settimo Milanese) supplemented by the producer with vitamins and trace elements
- Water: ad libitum, filtered water from municipal water main system
- Acclimation period: from 14-JUL-1999 to 14-DEC-1999

ENVIRONMENTAL CONDITIONS
- Temperature: 19 ± 2°C
- Humidity: 55 ± 10%
- Air changes: about 15-20 per hour filtered on HEPA 99.97%
- Photoperiod: 12 hrs dark / 12 hrs light (7 a.m. - 7 p.m.)

IN-LIFE DATES: From 14-JUL-1999 to 17-DEC-1999

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL

VEHICLE
Not applicable
Duration of treatment / exposure:
Single administration
Observation period (in vivo):
1, 24, 48 and 72 hrs after the test article application
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing and time after start of exposure: at 24 hours post-instillation a washout was performed.
Both eyes of each experimental animal selected for the study were examined within 24 hours of testing. Only animals without eye irritation, ocular defects or pre-existing corneal injury were used. The test article (0. 1 mL) was placed in the conjunctival sac of the right eye of each animal, after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about 3-4 seconds in order to prevent loss of the material. The other eye (the left eye), remaining untreated, served as control.
After the 24-hour reading, the cornea was examined after instillation of one drop of 1% sodium fluorescein and successive washing out with sterile saline solution.

SCORING SYSTEM:
The ocular reactions were scored according to the scale presented in Table 1 below in "any other information on materials and methods incl. tables".
The illustrated guide issued by the U.S. Consumer Product Safety Commission (CPSC) was used as a reference source for evaluating and scoring the reactions. The ocular irritation scores were evaluated in conjunction with the nature and reversibility or otherwise of the responses observed.

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #2 and #3
Time point:
other: 1 hr
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 24 hrs
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #2 and #3
Time point:
other: 24, 48 and 72 hrs
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal: #1, #2 and #3
Time point:
other: 1, 24, 48 and 72 hrs
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2 and #3
Time point:
other: 1, 24, 48 and 72 hrs
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal: #1, #2 and #3
Time point:
other: 1, 24, 48 and 72 hrs
Score:
0
Max. score:
0
Irritant / corrosive response data:
Slight (grade 1) conjunctival redness was noted in all rabbits at the reading carried out 1 hour after treatment. No eye changes were subsequently observed.
Negative results were obtained at the fluorescein staining performed 24 hours after the test article application.
Other effects:
Neither mortality nor adverse general clinical modifications were seen during the study.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to this study, the test article was not classified as an ocular irritant.
Executive summary:

The ocular irritancy potential of the test substance was assessed in vivo in accordance with the standardised guidelines OECD 405 and EU Method B.5 and in compliance with good laboratory practices (GLP).

 

A single ocular application of 0.1 mL of the test substance (purity: 100 %) was instilled into the conjunctival sac of New-Zealand rabbits (3 males). The other eye remained untreated and served as the control. The animals were observed for ocular effects 1, 24, 48 and 72 h after administration of the test material.

 

No general clinical signs were noted in any rabbit. Locally, at the application site, slight conjunctival redness (grade 1) was transiently observed at 1 hr post-instillation in all 3 rabbits (fully reversible within 24 hrs).The mean scores at 24, 48 and 72 hrs of the 3 rabbits were 0 for corneal opacity, 0.66 for iritis, 0 for redness and 0 for chemosis of the conjunctivae.

 

Therefore, in this study, the test article was not an ocular irritant.