Registration Dossier
Registration Dossier
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EC number: 222-225-5 | CAS number: 3391-83-1
Skin irritation / corrosion
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:
- 1 980
- 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
- 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
Constituent 1
- 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.
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