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Diss Factsheets

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study, to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Details on test material:
- Substance type: technical product
- Physical state: red viscous liquid
- Expiration date of the lot/batch: April 2007
- Storage condition of test material: Room temperature
- Other: pH of 5 of a 10% mixture of test substance in water

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Covance Research Products Inc., Denver, PA
- Age at study initiation: 13-14 weeks
- Weight at study initiation: 2.5-2.85 kg
- Housing: Individually housed in suspended stainless steel and wire mesh cages with absorbent paper below
- Diet (e.g. ad libitum): PMI certified rabbit diet 5322. The amount of feed administered to the animals was limited on a daily basis. The animals received new feed each day and the old feed, if any, was discarded.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 16 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 29 May 2002 To: 10 June 2002

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml

Duration of treatment / exposure:
The upper and lower lids were gently held together for approximately 1 second to prevent loss of the substance, and the treated eyes of the three animals remained unwashed
Observation period (in vivo):
10 days
Number of animals or in vitro replicates:
3 males
Details on study design:
SCORING SYSTEM:
Draize standard eye irritation grading scale

TOOL USED TO ASSESS SCORE: fluorescein dye under UV light

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Time point:
other: mean of 24, 48 and 72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Time point:
other: mean of 24, 48 and 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Time point:
other: mean of 24, 48 and 72 h
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
1.4
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean of 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean of 24, 48 and 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean of 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0.8
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
cornea opacity score
Remarks:
(opacity)
Basis:
animal #1
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Remarks:
(opacity)
Basis:
animal #2
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Remarks:
(opacity)
Basis:
animal #3
Time point:
other: mean of 24, 48 and 72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
cornea opacity score
Remarks:
(opacity)
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0.2
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritant / corrosive response data:
Exposure to 0.1 ml elicited conjunctival responses in all animals. Redness of Grade 1 was evident for all animals at the 1 h evaluation, which had increased to Grade 2 in two animals at 24 h. Redness decreased slightly at the 48 and 72 h evaluations, when two animals had redness of Grade 1 and one animal Grade 2. No redness was observed at day 7. Chemosis of Grade 1 was evident for one animal and chemosis of Grade 2 was evident for two animals at 24 h. Chemosis of Grade 1 was evident for two animals at the 48 h evaluation. White discharge of Grade 2 or 3 was evident for two animals at 24 h. Signs of conjunctival irritation were not evident at day 7. No necrosis or ulceration of the conjuctiva or nictitating membranes was seen.

Signs of irritation of the iris were not evident.

Corneal reponses were evident for two animals during the study. Corneal opacity of Grade 1 was evident for one animal at the 24 and 48 h evaluations. Dye retention (Grade 1 or 2) was evident for two animals at the 24 h and 48 h observations, and in one of these animals at 72 h. Stippling (area of pinpoint roughening) was observed in the eyes of two animals at the 72 h evaluation only. Corneal responses were not evident by day 7.

All changes were fully reversible within 7 days
Other effects:
All animals survived to study termination and were free of clinical signs during the study

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
In a GLP study conducted according to OECD guideline 407, instillation of undiluted substance (0.1 ml) into the conjuctival sac of one eye of each of three rabbits (unwashed) caused moderate (but reversible) irritation to the conjuctiva, no irritation to the iris, and mild (but reversible) irritation to the cornea. In accordance with the EU CLP Regulation, the substance does not require classification as an eye irritant.
Executive summary:

In a GLP study conducted according to OECD guideline 405, undiluted EC# 457-320-2 test substance (0.1 ml) was instilled into the conjuctival sac of the right eye of three New Zealand White rabbits. The upper and lower lids were gently held together for approximately one second to prevent loss of the test material, and the eyes of the three animals remained unwashed. The untreated eye served as the control. Signs of ocular irritation (using the Draize scoring method) were assessed at 1, 24, 48 and 72 h post-instillation, and on days 7 and 10.

Conjuctival responses (redness, chemosis and discharge) were elicited in all three animals (Grades 1 to 3) at 1, 24, 48 and/or 72 h timepoints, but no signs of conjuctival irritation were observed by day 7. No signs of irritation to the iris was observed throughout the study. Corneal responses (opacity, dye retention and stippling) were seen in two animals (Grades 1 or 2) at 24, 48 and/or 72 h observation periods, but no signs of corneal irritation were seen at day 7. All animals survived and were free of clinical signs during the study.

In conclusion, instillation of the substance (0.1 ml) into the conjuctival sac of one eye of each of three rabbits caused moderate but reversible irritation to the conjuctiva, no irritation to the iris, and mild but reversible irritation to the cornea. In accordance with EU CLP regulations, the substance would not require classification as an eye irritant.