Registration Dossier

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

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted 1981
Deviations:
no
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

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, Fuellinsdorf, Switzerland
- Age at study initiation: 14 - 15 weeks
- Weight at study initiation: 2.4 - 2.5 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: four days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): 10 - 15
- 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 (volume or weight with unit): 0.1 g
- Concentration (if solution): undiluted

Duration of treatment / exposure:
Eyes not washed out
Observation period (in vivo):
1-, 24-, 48- and 72 hours
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: according to OECD Guideline 405

TOOL USED TO ASSESS SCORE: hand-slit lamp and diagnostic-lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3 animals
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
3 animals
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
3 animals
Time point:
other: 24, 48, 72 hours
Score:
0.53
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
3 animals
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
After 1 hour of treatment a redness and chemosis score of 2 was found in all animals. After 24 hours the chemosis was fully reversible and a mean conjunctival redness score of 1.3 (2/1/1) was found. After 48 hours only one animal showed a conjunctival redness score of 1 which was reversed after 72 hours. In the area of application no discoloration of the cornea and conjunctivae was observed which could be related to effects of the test article. No corrosion was observed at each of the measuring intervals.
Other effects:
No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred. The body weight gain of all rabbits was similar.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met