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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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
no guideline available
Version / remarks:
Conducted according to the method published by the FDA (Fed.Reg.28 (119), 5582, 1963) and Draize and Kelly (Drug Cosmet.Industr.71 (1952) 36).
Principles of method if other than guideline:
Conducted according to the method published by the FDA (Fed.Reg.28 (119), 5582, 1963) and Draize and Kelly (Drug Cosmet.Industr.71 (1952) 36).
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
11-oxahexadecan-16-olide
EC Number:
222-225-5
EC Name:
11-oxahexadecan-16-olide
Cas Number:
3391-83-1
Molecular formula:
C15H28O3
IUPAC Name:
11-oxahexadecan-16-olide
Test material form:
liquid
Specific details on test material used for the study:
Batch: T-02437, Number 148983.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period: 5 days

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
24hr, 48hr, 72hr
Number of animals or in vitro replicates:
6 rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not completed.
- Time after start of exposure: 0hr, 24hr, 48hr, 72hr.

SCORING SYSTEM:
- Method of calculation: As per Draize standard scoring scheme.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
At 24 hours only, 2 rabbits out of 6 rabbits scored 1 for redness out of 4. The score for both of these rabbits was 0 at 48 hours.
Other effects:
No local or systemic affects were observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Musk R1 did not cause eye irritation after a single application of 0.1 mL of neat substance after 72 hours and does not fulfill the criteria for classification.

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