Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline compliant

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes
Remarks:
Experimental Toxicology and Ecology, BASF Aktiengesellschaft, 67056 Ludwigshafen/Rhein, Germany

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: Powder
- Storage condition of test material: room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan-Winkelmann GmbH, Borchen, GER
- Age at study initiation: Young adult animals
- Weight at study initiation: 2.99-3.36 kg
- Housing: Single housing in stainless steel wire mesh cages with grating
- Diet: Kliba-Labordiaet, Provimi Kliba SA, Kaiseraugst, Switzerland (about 130 g/animal per day).
- Water: Tap water ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated left eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml bulk volume (about 24 mg of the comminuted test substance)
Duration of treatment / exposure:
applied in a single dose, washed out after 24 hours
Observation period (in vivo):
7 days
Readings: 1 h, 24 h, 48 h, 72 h and 7 d after application
Number of animals or in vitro replicates:
2 males and 1 female
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the substance was washed out with tap water about 24 hours after application (before 24 haur reading).

SCORING SYSTEM: according to OECD 405

TOOL USED TO ASSESS SCORE: not specified

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-72h
Score:
0.2
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-72h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24-72h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24-72h
Score:
1.7
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24-72h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-72h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritant / corrosive response data:
At the 1 hour reading point, chemosis was observed in all three animals, reversible within 72 hours. At this time point, conjunctival redness could not be read because of staining due to the color of the test substance. Corneal opacity (grade 1) was observed in one animal, reversible within 72 hours. At the 24 hour point, conjunctival redness was observed in all three animals with a grading of 2, reversing back to normal within 7 days. The individual average conjunctival scores were 2.0, 2.0 and 1.7, therefore the substance is considered as irritating to the rabbit eye.

Applicant's summary and conclusion

Conclusions:
Based on the average conjunctival redness scores of 2 in two out of three animals, the substance is considered to be irritating to the eye of the rabbit.
Executive summary:

The potential of the test substance to cause damage to the conjunctiva, iris or cornea was assessed in 3 White New Zealand rabbits, subjected to a single ocular application of 0.1 ml bulk volume (about 24 mg) of the test substance. About 24 hours after application the eye was rinsed with tap water. The ocular reactions were assessed approximately 1, 24, 48, 72 hours and 7 days after application. Slight to moderate swelling and discharge were observed in all animals on the day of application. Index for conjunctival redness could not be read in all animals on this day because of staining due to the color of the test substance. 24 hours after application additionally moderate conjunctival redness was noted in all animals and slight corneal opacity was seen in 1 animal. The ocular reactions were reversible in all animals within 7 days after application at latest. The average scores (24 to 72 hours) for irritation were calculated to be 0.2 for corneal opacity, 0.0 for iris, 1.9 for conjunctival redness and 0.7 for chemosis. Based on the average conjunctival redness scores of 2 in two out of three animals, the substance is considered to be irritating to the eye of the rabbit.