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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:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970
Report date:
1970

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
(no details about the test substance; 50 µl instead of 100 µl test substance instilled, eyes were not washed out.)
Principles of method if other than guideline:
Standardized test method (BASF-Test): 50 µL of the test substance were applied to the conjunctival sac of one eye in 2 animals. The animals were observed after 10 min, 1 and 3 h on the day of treatment and up to 8 days afterwards. Findings were recorded daily. The eyes were not washed out after 24 hours as specified in OECD Guideline 405.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS

Source: Gaukler
Weight at study initiation: 2.05 kg (mean)
Diet: ad libitum
Water: ad libitum

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The adjacent eye served as control treated with NaCl.
Amount / concentration applied:
TEST MATERIAL

Amount(s) applied (volume or weight with unit): 50 µL
Duration of treatment / exposure:
Single application (not washed out)
Observation period (in vivo):
72 h (study was interrupted after 72 h due to reversibility of observed effects)
Number of animals or in vitro replicates:
2 animals
Details on study design:
SCORING SYSTEM: Draize scoring system, as recommended by the OECD Testing Guideline 405

TOOL USED TO ASSESS SCORE: fluorescein (at the end of exposure period)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
(animal #1 and #2)
Time point:
other: mean over 24, 48 and 72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
(animal #1 and #2)
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: no effects observed
Irritation parameter:
iris score
Basis:
mean
Remarks:
(animal #1 and #2)
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: no effects observed
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
(animal #1 and #2)
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: no effects observed
Other effects:
No other findings were observed.

Any other information on results incl. tables

Findings animal #1 / #2:

 Time

Redness

10 min

1 / 1

1 h

1 / 1

3 h

1 / 1

24 h

1 / 1

48 h

1 / 1

72 h

0 / 0

Mean (24 – 48 – 72 h)

0.7 / 0.7

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The mean conjuctivae score was 0.7, the mean cornea score was 0, the mean iris score was 0 and the mean chemosis score was 0 (all at 24, 48 and 72 hours) The test substance is not classified as an eye irritant according to EU CLP.
Executive summary:

The eye irritation potential of the test substance was determined in accordance with the OECD Guideline for Testing of Chemicals 405. 50 µl of the test substance was applied in a single application with the adjacent eye acting as a control treated with NaCl. The mean conjuctivae score was 0.7, the mean cornea score was 0, the mean iris score was 0 and the mean chemosis score was 0 (all at 24, 48 and 72 hours) The test substance is not classified as an eye irritant according to EU CLP.