Registration Dossier

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
Study period:
presumably 1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Methodical details are missing

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
3 male albino rabbits were used. 0.1 mL was instilled once into the left conjunctival sac, while the right eyes were used as controls. Observations were made at 20 min and at 3 – 72 h after application.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
no data

Test animals / tissue source

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

Test system

Vehicle:
not specified
Controls:
other: right eyes were used as controls
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
single application
Observation period (in vivo):
Observations were made at 20 min and at 3 – 72 h after application.
Number of animals or in vitro replicates:
3 m
Details on study design:
SCORING SYSTEM: no data

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Remarks on result:
other: slight irritation was observed

Any other information on results incl. tables

Within 20 min moderate erythema in 2/3 rabbits, which persisted at the 3 h observation period and subsided in 1 of the 2 two rabbits after 5 hours. At 24 h moderate erythema in one rabbit was slightly increased, while the other two rabbits were negative. At 48 and 72 h all the eyes were essentially negative.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information
Conclusions:
ATBC was slightly eye irritating
Executive summary:

3 male albino rabbits were used. 0.1 mL was instilled once into the left conjunctival sac, while the right eyes were used as controls. Observations were made at 20 min and at 3 – 72 h after application.

Within 20 min moderate erythema in 2/3 rabbits, which persisted at the 3 h observation period and subsided in 1 of the 2 two rabbits after 5 hours. At 24 h moderate erythema in one rabbit was slightly increased, while the other two rabbits were negative. At 48 and 72 h all the eyes were essentially negative.