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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well reported study, no information about housing

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: FDA-Richtlinien (Federal Register, Vol. 38, No. 187, 1973)
Principles of method if other than guideline:
0.1 ml of the product has been applied in the conjunctival sac of the rabbits eye and observations has been done untill after 72 hours.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
SPF-Albino-Himalayan-Kaninchen

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: 2nd eye serves as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with NaCl solution
- Time after start of exposure: after 24h


SCORING SYSTEM: FDA-Richtlinien Klassifizierung


TOOL USED TO ASSESS SCORE: magnifying glass / slit lamp / fluorescein

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72
Score:
0.08
Max. score:
8
Reversibility:
fully reversible
Remarks on result:
other: Score 0.0 - 0.5 considered not irritating

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information