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:
From 11 FEB 1975 to 18 FEB 1975.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report which meets basic scientific principles.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: FDA guideline (Fed. Reg., Vol. 37, No. 38, 1972)
Deviations:
not specified
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 ml
Duration of treatment / exposure:
24 h (5 animals, group 1)
5 min (3 animals, group 2)
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
8
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: with 300 ml water for 2 min
- Time after start of exposure: 24 h (5 animals, group 1) or 5 min (3 animals, group 2)

SCORING SYSTEM: in accordance with OECD TG 405

TOOL USED TO ASSESS SCORE: fluorescein, UV light

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1 (group 1)
Time point:
other: 24, 48, 72 h.
Score:
0.67
Max. score:
4
Reversibility:
fully reversible
Remarks:
72 h after application.
Irritation parameter:
cornea opacity score
Basis:
animal: #2 - #8
Time point:
other: 24, 48, 72 h.
Score:
0
Max. score:
4
Remarks on result:
other: group 1 + group 2
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h.
Score:
0
Max. score:
2
Remarks on result:
other: group 1 + group 2
Irritation parameter:
conjunctivae score
Basis:
animal: #2 (group 1)
Time point:
other: 24, 48, 72 h.
Score:
1
Max. score:
3
Reversibility:
fully reversible
Remarks:
72 h after appl.
Remarks on result:
other: redness
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #3 (group 1)
Time point:
other: 24, 48, 72 h.
Score:
0.67
Max. score:
3
Reversibility:
fully reversible
Remarks:
72 h after appl.
Remarks on result:
other: redness
Irritation parameter:
conjunctivae score
Basis:
animal: #4, #5 (group 1)
Time point:
other: 24, 48, 72 h.
Score:
0.33
Max. score:
3
Reversibility:
fully reversible
Remarks:
48 h after appl.
Remarks on result:
other: redness
Irritation parameter:
conjunctivae score
Basis:
animal: #6 - #8 (group 2)
Time point:
other: 24, 48, 72 h.
Score:
0
Max. score:
3
Remarks on result:
other: redness
Irritation parameter:
chemosis score
Basis:
animal: #2 (group 1)
Time point:
other: 24, 48, 72 h.
Score:
0.33
Max. score:
4
Reversibility:
fully reversible
Remarks:
48 h after appl.
Irritation parameter:
chemosis score
Basis:
animal: #1, #3 - #5 (group 1), #6-#8 (group 2)
Time point:
other: 24, 48, 72 h.
Score:
0
Max. score:
4
Remarks on result:
other: group 1 + group 2
Irritant / corrosive response data:
Application of test substance resulted in conjunctival redness score 1 for all animals of group 1 for up to 48 hours. Additionally, animal #1 (group 1) showed corneal opacity score 1. The animals of group 2 showed one hour after application conjunctival redness score 1. No other responses were noted. 72 h after application no effects were observed.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP regulation
Conclusions:
According to the classification criteria of Regulation (EC) No 1272/2008 the test material is not irritating to eyes under these test conditions. This conclusion is legitimate as five animals (group 1) were tested basically in accordance with today's standard methods regarding dosing, exposure duration, scoring system, reading time points and the observed eye responses were fully reversible 72 hours after application.
Executive summary:

The test material was tested for eye irritancy according to FDA guideline (Fed. Reg., Vol. 37, No. 38, 1972). 0.1 ml test substance was applied to the conjunctival sac of one eye each of eight rabbits (washing after 24 h in 5 animals, group 1, or after 5 minutes in 3 animals, group 2) and eye responses were observed for seven days. Only slight eye responses were noted, fully reversible within 72 h. The test item is not irritating to eyes according to the classification criteria of Regulation (EC) No 1272/2008.