Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
From 07 SEP 1976 to 23 SEP 1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: FDA guideline, similar to OECD 405.
Cross-reference
Reason / purpose:
reference to same study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: FDA guideline (Federal Register Vol. 38, nr. 187, p. 27019, 1973)
Deviations:
no
GLP compliance:
no
Remarks:
study was performed previous to GLP implementation

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.5 - 2.0 kg
- Housing: single
- Diet: ERKA 8300 (Futtermittelwerke Robert Koch oHG, Hamm, Germany), ad libitum
- Water: ad libitum

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
Duration of treatment / exposure:
24 h after exposure eyes were washed with physiological saline.
Observation period (in vivo):
72 h with observation time points at 1, 7, 24, 48 and 72 h after application.
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 h

SCORING SYSTEM: according to Draize Scale.

TOOL USED TO ASSESS SCORE: loupe / fluorescein (at 48 and 72 h reading)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant since no effect
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: not relevant since no effect
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: #2, #5 and #6 each
Time point:
other: mean of 24, 48 and 72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: #1, #3 and #4 each
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
3
Reversibility:
other: not relevant since no effect
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant since no effect
Irritant / corrosive response data:
Individual animal data for animal #1, #2, #3, #4, #5, #6 at time point 1h / 7h / 24h / 48h / 72 h

cornea score: 0/0/0/0/0 0/0/0/0/0 0/0/0/0/0
0/0/0/0/0 0/0/0/0/0 0/0/0/0/0

iris score: 0/0/0/0/0 0/0/0/0/0 0/0/0/0/0
0/0/0/0/0 0/0/0/0/0 0/0/0/0/0

conjunctivae redness: 1/1/0/0/0 1/1/1/0/0 2/1/0/0/0
1/1/0/0/0 2/1/1/0/0 1/1/1/0/0

chemosis: 0/0/0/0/0 1/0/0/0/0 1/0/0/0/0
1/0/0/0/0 1/0/0/0/0 1/0/0/0/0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material did not show remarkable irritating potential to the eyes of animals under test conditions which are basically in accordance with todays standard methods regarding dosing, exposure duration, scoring system and reading time points. Therefore, it is concluded that the submission substance is not irritating to eyes.
Executive summary:

Test material was subject to a test of eye irritancy according to FDA guidelines (Fed. Reg. Vol. 38, No. 187, p. 27019, 1973). 100 mg of substance were applied to one eye of six animals each. The eyes were washed 24 h after application and eye responses were noted for 72 h after start of the exposure. Only slight effects could be observed (conjunctiva redness score of 1 or 2 one hour after application in all animals, the effect was fully reversible within 48 h; iris score = 0 at all readings; cornea score = 1 in 2 out of 6 animals one hour after application, but effect fully reversible with 7 hours; Chemosis score = 1 in 5/6 animals one hour after application, effect fully reversible within 7 hours). Overall the effects seen were minimal and it is concluded that the test material is not irritating to eyes.