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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:
1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
February 24, 1987
Deviations:
not specified
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
impurity
Type:
impurity
Type:
impurity
Test material form:
liquid
Specific details on test material used for the study:
TEST MATERIAL NAME (as stated in study report): TK 12437 (Trade Name: Irgastab CH 302)

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor; Batch No. 08520495
- Expiration date of the lot/batch: July, 1996
- Purity: within the product specifications

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GMBH, Chemisch-pharmazeutische Fabrik, D-7950 Biberach/Riss
- Weight at study initiation: 2430 to 2600 g
- Housing: individually in metal cages
- Diet (e.g. ad libitum): Standard rabbit pellet - Nafag No. 814, Gossau, Switzerland; ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-3 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
Single dose to left eye. The lids were then held together for about bne second in order to prevent loss of the test article.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 male animals
Details on study design:
SCORING SYSTEM: per guideline

TOOL USED TO ASSESS SCORE: slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Reversibility:
fully reversible within: 24 hours
Irritant / corrosive response data:
No corneal, or iridal effects were seen in this study. Conjunctival redness was seen in all 3 treated eyes 1 hour after instillation (Grade 2), and in 2 of 3 treated eyes at 24 hours (Grade 1). Grade 1 chemosis was seen in all 3 treated eyes 1 hours after instillation. All eyes were normal at 48 hours post-treatment. See attached data table.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Not classified by CLP criteria
Conclusions:
In a guideline (OECD 405) in vivo eye irritation study, Irgastab CH 302 was not irritating to the rabbit eye. No corneal, or iridal effects were seen in this study. Conjunctival redness was seen in all 3 treated eyes 1 hour after instillation (Grade 2), and in 2 of 3 treated eyes at 24 hours (Grade 1). Grade 1 chemosis was seen in all 3 treated eyes 1 hours after instillation. All eyes were normal at 48 hours post-treatment.