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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:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: METHOD: FEDERAL REGISTER 38 No.187 § 1500.42 (EYE) PAGE 27019; SEPT. 27, 1973
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Korantin SC 9437 (now: Korantin MAT)
- Physical state: liquid
- Analytical purity: ca. 100 % (UVCB)

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: about 3 to 4 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: more than 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 2 °C
- Humidity (%): 55 +- 10
- Air changes (per hr): completely air-conditioned, 100 % of fresh air, filtered through Class C fine filter
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animals
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
single application, not washed out
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
not washed out

SCORING SYSTEM: as described in OECD 405 guideline

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
1.17
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: mean scores: 0.33 in 2/6 animals, 1 in 2/6 animals, 1.67 in 1/6 animals, 2.67 in 1/6 animals
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
0.83
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: mean scores: 0 in 1/6 animals, 1 in 5/6 animals
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
1.73
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: mean scores: 0.67 in 1/6 animals, 1.67 in 1/6 animals, 2 in 4/6 animals
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
2.67
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: mean scores: 0.67 in 1/6 animals, 1 in 1/6 animals, 2.33 in 2/6 animals, 3 in 1/6 animals, 3.67 in 1/6 animals

Any other information on results incl. tables

1 h after application: slight reddening rabbits, severe or very severe swelling with vesication and severe or very severe discharge from

the conjunctivae. In addition, slight opacity of the cornea in all rabbits and congestion of the iris in 2 rabbits.

2 to 3 d after application: purulent discharge in 5 rabbits.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU