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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
other: EEC Directive 79/381, annex V, Part B
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG CH 4414 Fuellinsdorf I Switzerland
- Age at study initiation: l4 - 15 weeks
- Weight at study initiation: 2.5 - 2.8 Kg
- Housing: housed individually in stainless steel cages equipped with an automatic cleaning and drinking system
- Diet: The diet consisted of pelleted standard Kliba #341 rabbit maintenance diet, Batch 92/83 ad lihitum.
- Water: Tap water ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 55 ± 10 %
- Air changes (per hr): 10 - 15 air changes per hour.
- Photoperiod: 12 hour cycle dark/light with artificial fluorescent light

Test system

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


Observation period (in vivo):
1, 24, 48 and 72 hours
Number of animals or in vitro replicates:
2 male and 1 female

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1 and #2
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: not rinsed eye
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.67
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: not rinsed eye
Irritation parameter:
iris score
Basis:
animal: #1, #2 and #3
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: not rinsed eye
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: #1 and #3
Time point:
24/48/72 h
Score:
0.67
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: not rinsed eye
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: not rinsed eye
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Reversibility:
fully reversible within: 48 hour
Remarks on result:
other: not rinsed eye
Irritation parameter:
chemosis score
Basis:
animal: #2 and #3
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible within: 72 hour
Remarks on result:
other: not rinsed eye
Other effects:
In the area of application a brown discoloration of the conjunctivae which could be related to effects of the teat article was observed during the observation period.

TOXIC SYMPTOMS / MORTALITY
No acute toxic aymptoma were observed in the animals during the teat period, and no mortality occurred.

NECROPSY
Due to the reaults obtained, no macroscopic organ examination was indicated.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified according to the CLP Regulation (EC 1272/2008)
Conclusions:
The substance is not irritating for rabbit eyes.
Executive summary:

The substance has been tested for eye irritation according to the OECD guideline 405 and EEC Directive 79/381, annex V, Part B. During the test 2 male and 1 female rabbits are treated with 0.1 g of the test compound.

Mean values at 24, 48 and 72 hours corneal opacity were 0.00 in two animals (#1 and #2) and 0.67 in one animal (#3). Mean values at 24, 48 and 72 hours for iris were 0.00 in all three animals. The conjunctivae scores as mean values at 24, 48 and 72 hours were: for redness 0.67 in animals #1 and #3 and 1 in animal #2; for chemosis 0.33 in animal #1 and 1 in animals #2 and #3. All effects observed were fully reversible within the end of the 72 -hour study period, except in one animal (animal #2 showed a redness score 1 at 72 hours). None of the treated eyes was rinsed after the test item application. Moreover, the substance is a powder and thus it is even more necessary to rinse the eye in order to exclude any effects that could occur due to its physical state. In addition, a fully reversibility was observed within 72 hours in all animals besides one animal (#2). Therefore, it is reasonable to expect that reversibility within 21 days will occur also in animal #2 even if it a fully reversibility was not possible to be observed within the 72 hours study period.