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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1980
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 by Draize (J.Pharm.Exptl.Therap.82 (1944) 377-390.
Principles of method if other than guideline:
Conducted according to the method by Draize (J.Pharm.Exptl.Therap.82 (1944) 377-390.
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:
1,7-dioxacycloheptadecan-8-one
Test material form:
liquid
Specific details on test material used for the study:
Batch: T-02437, Number 148983.

Test animals

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

Test system

Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.5 mL of neat solution
Duration of treatment / exposure:
24 hour exposure
Observation period:
0hr, 24hr, 48hr, 72hr.
Number of animals:
6 rabbits
Details on study design:
TEST SITE
- Area of exposure: 1 inch x 1 inch
- Type of wrap if used: Impervious material to maintain the test patches in position and to retard evaporation of volitile substances.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not completed.

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) : 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:
erythema score
Basis:
mean
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of weak irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Score:
1.2
Max. score:
4
Reversibility:
not specified
Remarks:
Only tested up to 72 hours
Remarks on result:
probability of weak irritation
Other effects:
No other local or systemic affects observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Musk R1 caused only slight skin irritation after a single application of 0.1 mL of neat substance after 72 hours and does not fulfill the criteria for classification.
Executive summary:

Musk R1 caused only slight skin irritation and does not fulfill the criteria for classification.