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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 26 AUG 1976 to 16 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
- Housing: single
- Diet: ERKA 8300, Robert Koch oHG/ Hamm, Germany, ad libitum
- Water: tap water ad libitum

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 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

TOOL USED TO ASSESS SCORE: loupe / fluorescein (for 24 and 48 h reading)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #3 and #4 each
Time point:
other: mean of 24, 48 and 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
cornea opacity score
Basis:
animal: #2 and #5 each
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant since no effect
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
other: mean of 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: the shortened observation period of 72 h
Remarks on result:
other: considered to be reversible within a prolonged observation period of 7 days
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: #1, #2, #3, #4 and #5 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:
conjunctivae score
Remarks:
redness
Basis:
animal #6
Time point:
other: mean of 24, 48 and 72 h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: the shortened observation period of 72 h
Remarks on result:
other: considered to be reversible within a prolonged observation period of 7 days
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 data for animal #1, #2, #3, #4, #5 and #6 after 1h / 7h / 24h / 48h / and 72h

cornea score: 1/1/1/0/0, 1/1/0/0/0, 2/1/1/0/0, 1/1/1/0/0, 0/0/0/0/0, 1/1/1/1/1
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, 0/0/0/0/0, 1/0/0/0/0, 1/1/0/0/0, 1/0/0/0/0, 0/1/1/1/1
conjunctivae chemosis: 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, 0/1/0/0/0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material was not irritating to eyes in all 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. The eyes were washed 24 h after application and eye responses were noted for 72 h after start of the exposure. No iridial effects were observed in any animal, and only 1/6 animals had a chemosis score of 1 in the 7 h reading which was completely reversible within 24 h. Slight to moderate corneal effects were visible in 5/6 animals. Apart from 1 animal these effects were completely reversible within the observation time. Conjunctivae redness was observed in 4/6 animals, the effect was also reversible within 72 h for all animals apart from one. It can be concluded that a longer observation period would have resulted in a complete reversibility.