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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:
1996-03-18 to 1996-03-01
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

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:
solid: crystalline

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Chemical pharmaceutical factory Dr. K Thomae 88400 Biberach
- Weight at study initiation: 2.7 - 3.0 kg
- Housing: in fully air-conditioned rooms in separate cages arranged in a battery
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 50±20
- Photoperiod (hrs dark / hrs light):12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
1, 24, 48 and 72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with isotonic saline at 37°C
- Time after start of exposure: 24 hours

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.66
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.66
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
One and 24 hours after application the conjuntivae of the animals showed a diffuse beefly red colour and obvious swellings up to swellings with lids about half closed. The iris was sporadically reddned. One hour after application clear, colourless eye discharge was noted. 24 hours after application the cornea showed diffuse opacity areas. 48 hours after application definitely injected blood vessels were observed in two animals. 72 hours after application all signs of irritation were reversible.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the testing for primary eye irritation in the rabbit, the substance is slightly irritating to eye. But the effect does not result in a classification of the test item.
Executive summary:

The test item was subject to an Acute Eye Irritation/Corrosion Test in the rabbit according to OECD TG 405. For this purpose 100 mg of test material were instilled in the left conjunctival sac of three New Zealand white rabbits. 24 hours after application the treated eyes were washed out thoroghtly with isotonic saline at 30°C. The eyes were examined 1, 24, 48, and 72 hours after application of the test item. One and 24 hours after application the conjuntivae of the animals showed a diffuse beefly red colour and obvious swellings up to swellings with lids about half closed. The iris was sporadically reddned. One hour after application clear, colourless eye discharge was noted. 24 hours after application the cornea showed diffuse opacity areas. 48 hours after application definitely injected blood vessels were observed in two animals. 72 hours after application all signs of irritation were reversible.

Based on the testing for primary eye irritation in the rabbit, the substance is slightly irritating to eye. But the effect does not result in a classification of the test item.