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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: Older study: meets scientific standards with acceptable restrictions (limited number of animals in study, partly limited documentation).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972

Materials and methods

Test guideline
Qualifier:
no guideline followed
Guideline:
other: Study from 1972 (no guidelines available at the time the study was performed)
Deviations:
not applicable
Principles of method if other than guideline:
0.1 mL of undiluted sample was placed in the conjunctival sac of the right eye of each of 3 albino male and female rabbits and observations made over a period of 7 days for inflammation. The eyes were rinsed after 24 hrs and the left eye served as control.
Scoring according to Draize et al. (1944) J Pharm Exp Therap 82
GLP compliance:
no
Remarks:
Study from 1972 (GLP was not compulsory at the time the study was performed)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Lot/batch No.: 68 T 1
crude test substance (no further data)

Test animals / tissue source

Species:
rabbit
Strain:
other: albino

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
24 hrs
Observation period (in vivo):
168 hrs
Number of animals or in vitro replicates:
3 male and female NZW rabbits

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 hr
Score:
14
Max. score:
110
Reversibility:
fully reversible within: 120 hrs

Any other information on results incl. tables

Numerical evaluations at the end of ... hrs

Animal / Sex

1

24

48

72

120

168

1 - female

14

10

4

2

0

0

2 - female

14

8

4

2

0

0

3 - female

14

8

4

2

0

0

Average

14

8.6

4

2

0

0

Observations following application:

Immediate

Severe discomfort, with pawing, squealing, and trashing about the stocks

10 min

severe erythema, slight oedema, copious discharge

1 hr

moderate erythema, slight oedema, copious discharge

24 hrs

moderate erythema, very slight oedema, slight discharge

48 hrs

slight erythema and discharge

72 hrs

slight erythema

120 hrs

eyes normal; zero readings

168 hrs

eyes normal; zero readings

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information
Conclusions:
The substance was slighty irritating.
Executive summary:

In this older study 0.1 mL of undiluted sample was placed in the conjunctival sac of the right eye of each of 3 albino male and female rabbits and observations made over a period of 7 days for inflammation. The eyes were rinsed after 24 hrs and the left eye served as control. Scoring according to Draize et al. (1944) J Pharm Exp Therap 82.

With an average maximum score of 14 in one hour (possible: 110) the TS was classed as slightly irritating in male and female rabbits.