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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:
From 12 October 1992 To 16 October 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
Deviations:
no
Principles of method if other than guideline:
Draize test.
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: white powder
- Storage condition of test material: room temperature under silica gel

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheschire, U.K.
- Age at study initiation: 12-16 weeks old
- Weight at study initiation: 2.61-3.18 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-19
- Humidity (%): 53-55
- Air changes (per hr): 15
- Photoperiod : 12 hrs dark / 12 hrs light


IN-LIFE DATES: From: 12 October 1992 To: 16 October 1992

Test system

Vehicle:
not specified
Controls:
other: left eye was used for control purposes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): a volume of 0.1 ml of the test material, which was found to weight approximately 93 mg was placed into the conjunctival sac of the right eye
Duration of treatment / exposure:
not rinsed
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6 (4 males and 2 females)
Details on study design:

SCORING SYSTEM: Draize scale for scoring ocular irritation


TOOL USED TO ASSESS SCORE: examination of the eye was facilitated by use of the light source from a standard ophtalmoscope

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 hr
Score:
0.28
Max. score:
4
Reversibility:
fully reversible within: 72 hr
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hr
Score:
0.17
Max. score:
2
Reversibility:
fully reversible within: 24 hr
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 hr
Score:
0.83
Max. score:
3
Reversibility:
fully reversible within: 72 hr
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24,48 and 72 hr
Score:
0.55
Max. score:
4
Reversibility:
fully reversible within: 72 hr
Irritant / corrosive response data:
A single application of the test material to a right eye of six rabbits produced diffuse corneal opacity, iridial inflammation and moderate conjunctival irritation. Dulling of the normal lustre of the corneal surface was confined to one treated eye one hour after treatment. All treated eyes appeared normal 72 hours after treatment.
Other effects:
None

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

score at time point/ Reversibility Cornea
Max. score:4
Iris
Max. score:2
Conjunctivae
Max. score:3
Chemosis
Max. score:4
1h 0/0/0/d/0/0 1/1/1/1/1/1 2/2/2/2/2/2 2/2/2/2/2/2
24h 0/0/1/1/1/0 0/0/1/1/1/0 2/1/2/1/2/1 1/1/2/1/1/1
48h 0/0/1/1/0/0 0/0/0/0/0/0 1/1/1/1/1/1 1/0/1/0/1/0
72h 0/0/0/0/0/0 0/0/0/0/0/0 0/0/0/0/0/0 0/0/0/0/0/0
Average 24h, 48h, 72h 0.28 0.17 0.83 0.55
 Reversibility *)  c.  c.  c.  c.

d = dulling of the normal lustre of the corneal surface

c. = completely reversible

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this test, ITC 288 is slightly irritating to eyes. However, no classification is required according to the EU legislation (CLP regulation (1272/2008) and Directive 67/548/EEC).
Executive summary:

In a primary eye irritation study (Tuffnell, 1992), six New Zealand rabbits were exposed to ITC 288. Animals were observed for 3 days. Irritation was scored by the draize scale. Dulling of the normal lustre of the cornea surface was noted in one treated eye one hour after treatment. Diffuse corneal opacity was noted in three treated eyes at the 24 -hour observation and in two treated eyes at the 48 -hour observation. No other adverse corneal effects were noted. Iridial inflammation was noted in all treated eyes one hour after treatment and in three treated eyes at the 24 -hour observation. No other adverse iridial effects were noted. Moderate conjunctival irritation was noted in all treated eyes one hour after treatment with minimal to moderate conjunctival irritation at the 24 -hour observation and minimal conjunctival irritation at the 48 -hour observation. All treated eyes appeared normal 72 -hours after treatment. A single application of ITC 288 to the intact eye of six rabbits produced mild irritation which desappeared. Under the test conditions of this study, ITC 288 is slightly irritating to eyes but no classification is required according to the EU legislation (CLP regulation (1272/2008) and Directive 67/548/EEC).

This eye irritation study is classified as acceptable. It satifies the guideline requirement for an eye irritation study in the rats.