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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
Three animals were applied 100 µl of the test substance (RESOLIN Rotviolett FBL fl. 3. Umstellung) into the conjunctival sac. After 24 hours the eyes were washed with physiological saline. After 1, 24, 48, 72 hours and 7 days the eyes were scored for cornea, iris, conjunctivae and chemosis according to Draize.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
The animals were housed in wire cages typ III (high) at a room temperature of 22 ± 2° C and a relative humidity of ca. 50%. The dark/light cycle was 12 hours. The animals received a standard nutrition and water ad libitum.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
100 µl
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 animals
Details on study design:
Three animals were applied 100 µl of the test substance (RESOLIN Rotviolett FBL fl. 3. Umstellung) into the conjunctival sac. After 24 hours the eyes were washed with physiological saline. After 1, 24, 48, 72 hours and 7 days the eyes were scored for cornea, iris, conjunctivae and chemosis according to Draize.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: score = 0 at any time point
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: score = 0 at any time point
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Irritant / corrosive response data:
Cornea opacity, iris, conjunctivae and chemosis scores were 0 at any time point (24, 48 and 72 hours).
Other effects:
No data

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Cornea opacity, iris, conjunctivae and chemosis scores were 0 at any time point (24, 48 and 72 hours).
Executive summary:

Three animals were applied 100 µl of the test substance (RESOLIN Rotviolett FBL fl. 3. Umstellung) into the conjunctival sac. After 24 hours the eyes were washed with physiological saline. After 1, 24, 48, 72 hours and 7 days the eyes were scored according to Draize. Cornea opacity, iris, conjunctivae and chemosis scores were 0 at any time point (24, 48 and 72 hours).

RESOLIN Rotviolett FBL fl. 3. Umstellung was not irritating to the eyes.