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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; sufficiently documented and acceptable for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
0.1 ml of undiluted compound was placed in the conjunctival sac of the right eye of each of six albino male and female rabbits and observations made over a period of seven days for inflammation. The treated eyes were washed with sodium chloride solution USP after the 24-hour reading. The left eye served as control. The data were scored according to the method of Draize, Woodard and Calvery (Journal of Pharm. and Exp. Therapeutics, Vol. 82, Dec. 1944).
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Name of test material (as cited in study report): Desmodur PF; no further data given

Test animals / tissue source

Species:
rabbit
Strain:
other: albino
Details on test animals or tissues and environmental conditions:
no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the left eye served as control
Amount / concentration applied:
Amount(s) applied: 0.1 ml/animal
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
1, 24, 48, 72 hours and 5, 7 days after instillation
Number of animals or in vitro replicates:
3 males and 3 females
Details on study design:
see "Principles of method"

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
animal: #1, 2, 3, 4, 5, 6
Time point:
other: 24, 48, 72 hours
Score:
8.4
Max. score:
110
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
Observations following application:
Immediate: discomfort was slight
10 min and 1 hour: slight erythema, copius discharge
24 hours: areas of barely perceptible corneal dullness in four animals, slight to moderate erythema, copius discharge
48-120 hours: gradual improvement
168 hours: all scored zero
Other effects:
none

Any other information on results incl. tables

.

Applicant's summary and conclusion

Executive summary:

Mondur PF was not classed as an eye irritant in an eye irritation test on male and female rabbits. Slight to moderate erythema was observed 24 hours after instillation, which was fully reversible within 7 days.