Registration Dossier

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: Study comparable to guideline with acceptable restrictions (reduced reporting)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1959
Report Date:
1959

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Approximately 0.1 g of the test substance was applied to the conjuntival sac of two white Vienna rabbits. The other eye treated with physiological saline served as a control. Substance was not washed out and reading was performed 10 min, 1, 3, and 24, and 48 hours after instillation of the test substance. Scores given for ocular reactions were compatible to the Draize criteria.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 4,4´-Diamino-3,3´-dimethyl-diphenylmethan = o-"Toluidinbase", destilled, grinded
- Physical state: crystalline powder, creme-like coloured
- Analytical purity: 99-100%

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
not reported

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: one drop of saline into the other eye
Amount / concentration applied:
Amount applied: 100 mg
Duration of treatment / exposure:
single application
Observation period (in vivo):
2 days
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washed

SCORING SYSTEM: Descriptive scores were converted into Draize scores

Results and discussion

Results of in vivo studyopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-48 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-48 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24-48 h
Score:
0
Max. score:
3
Remarks on result:
other: slight erythema (score 1) observed on readings 10 min to 3 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-48 h
Score:
0
Max. score:
4

Any other information on results incl. tables

Slight, barely perceptible erythema was observed at observation times <24 hours. Ocular reaction reversed completely within 24 hours after instillation of the test substance.

Applicant's summary and conclusion