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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:
January 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Froxfield (UK)
- Age at study initiation: 13 weeks if age
- Weight at study initiation: 2.9 kg
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: yes but no details

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 °C
- Humidity (%): 30-70%
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
100 mg of the test substance was placed into the lower everted lid of one eye of each animal.
The eyelids were ten gently held together for one second before releasing. The contralateral eye remained untreated.
Duration of treatment / exposure:
1 h
Observation period (in vivo):
1 hour and 1 day after exposure
Number of animals or in vitro replicates:
1 animal
Details on study design:
The eyes were examined prior to instillation of the test substance to ensure that there was no pre-existing corneal damage, iridial or conjunctival inflammation.
One animal was treated initially, to ensure that if a severe response was produced, no further animals would be exposed. On this occasion, due to the severity of the reactions, no further animals were used.
The animal was observed daily for signs of ill health or toxicity.
Examination of the eyes was made after 1 hour and on two occasions one day after instillation. Observation of the eyes was aided by the use of a handheld light.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Remarks:
associated with necrosis and haemorrhage
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Remarks:
associated with nictating membrane swollen
Irritant / corrosive response data:
Corneal opacities developed one day after instillation.
Iridial inflammation (grade 2) was observed.
A diffuse crimson or beefy red colouration of the conjunctivae accompanied by swelling with the eyelids more than half closed was seen. Necrosis and haemorrhage was seen on the nictating membrane and lower eyelid. A red/brown discharge was also seen before the animal was killed.
Due to the severity of the reactions, the animal was killed one day after instillation and no further animals were treated.
Other effects:
There were no signs of toxicity or ill health in any rabbit during the observation period.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Based on the available results, the test substance is considered as severely eye irritating to the rabbit.
Executive summary:

A study was performed to assess the eye irritation of the test substance to the rabbit. One rabbit was administered a single ocular dose of 100 mg of the test substance and observed for one day after instillation. A single installation of the test substance into the eye of the rabbit elicited corneal opacification, severe iridial inflammation and conjunctival reactions. The animal was killed one day after instillation. Based on the available results, the test substance is considered as severely eye irritating to the rabbit.