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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 May 2007 to 31 October 2007
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no
Remarks:
The study was not commissioned with compliance with REACH as a goal, rather the study was commissioned during early product development.

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2,3,3,4,4,5,5-octafluoropentyl methacrylate
EC Number:
206-596-0
EC Name:
2,2,3,3,4,4,5,5-octafluoropentyl methacrylate
Cas Number:
355-93-1
Molecular formula:
C9H8F8O2
IUPAC Name:
2,2,3,3,4,4,5,5-octafluoropentyl 2-methylprop-2-enoate
Test material form:
liquid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 08230AB
- Purity: 99.8%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kuiper Rabbit Ranch (Gary, IN)
- Age at study initiation: 4 months of age
- Weight at study initiation: 2.84-3.09 kg
- Housing: housed individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.9 - 21.2°C
- Humidity (%): 27-401%
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: 16 May 2007 To: 24 May 2007

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 mL of undiluted test substance
Duration of treatment / exposure:
single exposure; the treated eye of each rabbit was rinsed with water 24 hours after dosing.
Observation period (in vivo):
1, 24, 48, 72-hours after test substance administration
Duration of post- treatment incubation (in vitro):
Not applicable
Number of animals or in vitro replicates:
3 animals
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: the treated eye of each rabbit was rinsed with water
- Time after start of exposure: 24 hours after dosing.

SCORING SYSTEM: according to EEC grading guidelines

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
animal: 1, 2, 3
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24 h
Remarks on result:
probability of weak irritation
Remarks:
conjunctiva discharge score of 1 at 1 hour in 1 animal
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Slight, clear fluid was discharged on the fur below the eye of two animals at the 1-hour time point. The animals were recovered from the signs of discharge at the 24-hour time point.
Other effects:
Throughout the study, no deaths occurred and none of the animals were found moribund.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The mean eye irritation score at 24, 48, and 72 hours for corneal opacity, iris lesion, conjunctival redness and chemosis were all 0 for 3 animals.
Executive summary:

Undiluted test substance was placed in the conjunctival sac of the right eye of each of the three female rabbits used in the study. The untreated left eye of each rabbit served as a control for comparison purposes. The treated eye of each rabbit was rinsed with water 24 hours after administration of the test substance and scored for irritation at 1, 24, 48, and 72 hours post-dose. 

 

Slight, clear fluid was discharged on the fur below the eyes of two animals at the 1-hour scoring interval. The rabbits completely recovered from signs of ocular discharge at the 24-hour scoring interval. 

The mean scores for corneal opacity, iris lesion, conjunctival redness and chemosis were all 0. 

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