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:
1976
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
The Draize rabbit eye irritation procedure was used to evaluate Myristyl Myristate in six separate studies. In each study, 0.1 ml of diluted or undiluted Myristyl Myristate was instilled into one eye of each rabbit with no subsequent washing;
The untreated eye served as control.
The treated eyes were examined and gradded on the Draize eye irritation scale at 24, 48 and 72 h.
The undiluted ingredient produced only minimal eye irritation.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: flakes

Test animals / tissue source

Species:
rabbit
Strain:
not specified

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
0.1 ml of undiluted ingredient
Duration of treatment / exposure:
72 h
Observation period (in vivo):
24, 48 and 72 h
Details on study design:
The Draize rabbit eye irritation procedure was used to evaluate Myristyl Myristate in six separate studies. In each study, 0.1 ml of diluted or undiluted Myristyl Myristate was instilled into one eye of each rabbit with no subsequent washing;
The untreated eye served as control.
The treated eyes were examined and gradded on the Draize eye irritation scale at 24, 48 and 72 h.
The undiluted ingredient produced only minimal eye irritation.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
not specified
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
ca. 2.67
Max. score:
2.67
Reversibility:
fully reversible
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
48 h
Score:
ca. 1
Max. score:
2.67
Reversibility:
fully reversible
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Score:
ca. 0.33
Max. score:
2.67
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
>= 0.33 - <= 2.67
Max. score:
2.67
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
not specified

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met