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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
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: The method of procedure is that suggested by Dr. Draize and described in "Appraisal of the safety of chemicals in foods, drugs amd cosmetics" published by the Association of Food and Drug Officials of the United States.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
Test material name (as stated in the report): GIV 81-1543=Musc 174

Test animals / tissue source

Species:
rabbit
Strain:
other: albino rabbits
Details on test animals or tissues and environmental conditions:
Three normal, healthy albino rabbit were used in this experiment

Test system

Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1mL of test materia
Duration of treatment / exposure:
instillation
Observation period (in vivo):
14 days after instillation
Number of animals or in vitro replicates:
3 rabbits
Details on study design:
Ecah animal had 0.1 mL of test sample instilled into the right eye with no further treatment.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal:
Remarks:
animal #1 ; animal #2 and animal 3#
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Na
Irritation parameter:
iris score
Basis:
animal: animal #1 ; animal #2 and animal 3#
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Na
Irritation parameter:
conjunctivae score
Basis:
animal: animal #1 ; animal #2 and animal 3#
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 72h
Irritation parameter:
chemosis score
Basis:
animal: animal #1 ; animal #2 and animal 3#
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Na
Irritation parameter:
other: Ulceration
Basis:
animal: animal #1 ; animal #2 and animal 3#
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Na

Any other information on results incl. tables

The scorings recorded were made according to the Draize scale for scoring ocular lesions.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
CERVOLIDE does not meet the criteria to be as Eye irritant Category 2  according to the CLP Regulation (EC) No. 1272/2008.
Executive summary:

The CERVOLIDE was tested in this study to determine his eye irritant potential according to the procedure is that suggested by Dr. Draize and described in "Appraisal of the safety of chemicals in foods, drugs amd cosmetics" published by the Association of Food and Drug Officials of the United States.

Observations and scoring by the Draize method were conducted immediately and 1 hour, 24 hours, 48 hours, 72 hours, 7 days and 14 days later. With 10%, conjunctival redness was observed in 3/3 animals at 1 hour and 24 hours. Reactions were absent by 48 hours. With 30%, conjunctival redness was observed in 3/3, 3/3 and 1/3 animals at 1 hour, 24 hours and 48 hours, respectively. Reactions were absent by 72 hours.With the neat material, conjunctival redness was observed in 3/3, 1/3 and 3/3 animals at 1 hour, 24 hours and 48 hours, respectively. Moderate conjunctival redness was observed in 2/3 animals at 24 hours. Chemosis was observed in 3/3 animals at 24 hours. Dose: 100 % Effects: eye effects; irritant effects Results: moderate conjunctival irritation which cleared within 72 hours

CERVOLIDE does not meet the criteria to be as Eye irritant Category 2  according to the CLP Regulation (EC) No. 1272/2008.