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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:
August 16, 2000
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:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
February 24, 1987
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Remarks:
Crl:KBL(NZW)BR
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, KiBlegg
- Age at study initiation: about 18 weeks
- Weight at study initiation: 3.37 kg
- Housing: separately in special rabbit cages (manufacturer: Becker; type K99/30 KU, floor area about 5400 cm2, a shelter with an integrated sitting board of about 1820 cm2; overall height: 60 cm;) with plastic grids placed on mobile racks
- Diet: ad libitum, diet for rabbits No. 814 and No. 5697, Eberle Nafag
- Water: ad libitum), tap water
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 21
- Humidity (%): 62 to 73
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 g


Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: No

SCORING SYSTEM: according to Draize

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

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Max. score:
2
Remarks on result:
probability of severe irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritant / corrosive response data:
Strong local irritations were seen, the study was finished, and the rabbit was humanely sacrificed. Immediately after instillation opacity (score 4) of the cornea was observed. The iris was not visible. The conjunctivae showed redness (score 3), chemosis (score 4) and discharge (score 3). The untreated eye was unchanged.
Other effects:
Results of Pretest:
The test material was screened for its irritating potential with the hen's egg test on the chorioallantoic membrane (HET-CAM). Fertile hen eggs on day 10 of incubation provided the test system. The egg shell was entered above the air cell by a dentist's rotary and then pared off. The shell with attached outer membrane and inner egg membrane was carefully opened. After the membrane had been moistened with isotonic sodium chloride solution, it was removed to expose the chorioallantoic membrane (CAM) of the fertilized egg, which lies immediately below. The chorioallantoic membrane (CAM) of fertilized and incubated hen eggs provides a suitable model for membranes with an intact and functional vascular system. The CAM has no nerve fibers in the early stages of development and is, thus, regarded as being insensitive to pain. The cumulative irritation score was 8.84. This revealed a moderate irritating potential and the animal study was started with one rabbit.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
The substance was regarded as corrosive to the eyes.
Executive summary:

A study according OECD TG 405 was conducted. According to the guideline the exposure of one animal is recommended if it is suspected that the test material might produce severe irritation. Therefore the study was started with one rabbit. For the primary eye irritation test, 0.1 g test material was applied into the conjunctival sac of the rabbit.

The first examination of the eyes followed immediately after instillation. No signs of pain were observed. Strong local irritations were seen, the study was finished, and the rabbit was sacrificed.

Immediately after instillation opacity (score 4) of the cornea was observed. The iris was not visible. The conjunctivae showed redness (score 3), chemosis (score 4) and discharge (score 3).The untreated eye was unchanged.

The substance was regarded as corrosive to the eyes.