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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
June - September 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Information removed from study report
- Age at study initiation: 13 weeks
- Weight at study initiation: 2678 to 2841 g
- Housing: individually in suspended metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 23
- Humidity (%): 33 to 53
- Air changes (per hr): ca. 18
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
Single instillation
Observation period (in vivo):
14 day observation period
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not washed

SCORING SYSTEM: Draize, 1959

TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.3
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.7
Max. score:
4
Reversibility:
other: experiment terminated early due to animal welfare considerations
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.3
Max. score:
2
Reversibility:
other: experiment terminated early due to animal welfare considerations
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
other: experiment terminated early due to animal welfare considerations
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3.3
Max. score:
4
Reversibility:
other: experiment terminated early due to animal welfare considerations
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Remarks on result:
other: Unable to assess reaction due to excessive swelling
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Remarks on result:
other: Unable to assess reaction due to excessive swelling
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
other: experiment terminated early due to animal welfare considerations
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3.7
Max. score:
4
Reversibility:
other: experiment terminated early due to animal welfare considerations
Irritant / corrosive response data:
The test material elicited primarily conjunctival irritation in the pilot animal, although Grade 1 corneal opacity was also evident 48 and 72 hours after instillation. Two more animals were treated based on the findings in the first animal. Corneal lesions, iridial and conjunctival inflammation quickly exceeded that previously observed in the pilot animal and within 48 hours the animals were sacrificed on humane grounds. Due to the severity of these ocular lesions in the two animals, it was not possible to determine their reversibility.
Other effects:
There was no evidence of systemic toxicity to treatment.

Any other information on results incl. tables

Under the conditions of this study the test material elicited corneal opacification, iridial inflammation and well-defined conjunctival irritation and is considered an eye irritant with the potential to cause serious damage to the eyes.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
In the key study for eye irritation, conducted according to OECD Test Guideline 405 and in compliance with GLP, the test material is concluded to be corrosive, based on corneal lesions, and thereafter iridial and conjunctival inflammation. The animals were sacrificed on humane grounds within 48 hours and therefore, it was not possible to determine the reversibility of the effect.