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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:
comparable to guideline study with acceptable restrictions
Remarks:
GLP-compliant study, available as unpublished report, adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Draize, J.H., Woodard, G., and Calvery, H.O., 1944
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
BUTASAN, off—white powder
Purity: 99.9 %

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: 1sf: (NZW), Isaac’s Farm, Litchfield, illinois
- Age at study initiation: young adult
- Weight at study initiation: 2.57 — 2.83 kilograms
- Housing: one per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: animals were quarantined for at least five days.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A mass of 39 mg, determined to occupy a volume of 0.1 ml of test material


Duration of treatment / exposure:
A single administration of the test material.
Observation period (in vivo):
Observations for signs of irritation were conducted on the first, second, and third days after dosing.
Number of animals or in vitro replicates:
3 males and 3 females per dose
Details on study design:
SCORING SYSTEM: The method of Draize (1944)

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
0.3
Max. score:
110
Reversibility:
fully reversible within: 48h
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
80
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
10
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.33
Max. score:
20
Reversibility:
fully reversible within: 48 hr
Irritant / corrosive response data:
The cornea and iris score were 0 at all time points in all animals. One rabbit had a conjunctivae score 4 and another a conjunctivae score 2 at 24 hr examination. In both cases irritation was resolved at 48 hr examination.

Applicant's summary and conclusion