Registration Dossier
Registration Dossier
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EC number: 401-700-2 | CAS number: 3100-36-5 CYCLOHEXADECENON; CYCLOHEXADECENONE
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- No mentioning of clinical and body weight observations, irritation readings only after 24 and 72 hours
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- yes
- Remarks:
- No mentioning of clinical and body weight observations, irritation readings only after 24 and 72 hours
- GLP compliance:
- yes
Test material
- Reference substance name:
- A mixture of cis- and trans-cyclohexadec-8-en-1-one
- EC Number:
- 401-700-2
- EC Name:
- A mixture of cis- and trans-cyclohexadec-8-en-1-one
- Cas Number:
- 3100-36-5
- Molecular formula:
- C16H28O
- IUPAC Name:
- (8E)-cyclohexadec-8-en-1-one; (8Z)-cyclohexadec-8-en-1-one
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Albino rabbits
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Not specified
- Weight at study initiation: 3.0 kg (average)
- Housing: Individually
- Diet: Ad libitum (Altromin standard diet for rabbits)
- Water: Ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 2
- Humidity (%): 50-60
- Air changes (per hr): Not specified
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From day 0 to day 7
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Remarks:
- Shaved and scarified
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- The test item was used undiluted and applicated dermally after warmed up in a waterbath.
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g - Duration of treatment / exposure:
- 24 hours
- Observation period:
- After 24 hours (directly after removing the patch) and after 72 hours. After 7 days, localizations were controlled finally.
- Number of animals:
- 5 animals
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm^2
- Type of wrap: Cellulose patch which was fixed by means of leucoplast. All the trunk of the animals was wrapped with a rubber cloth for 24 hours.
OBSERVATION TIME POINTS
24 hours, 72 hours and 7 days after start of treatment
SCORING SYSTEM:
- Method of calculation: According to Draize (1959, see "Any other information on materials and methods incl. tables). Substances with an index of primary irritation of 2 or less are no to mild stimulating substances, those with an index of 2 to 5 moderate ones and those with an index of 5 more are strong stimulants.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no irritation observed
- Remarks on result:
- no indication of irritation
- Remarks:
- Irritation was only checked at 24 and 72 hours.
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no irritation observed
- Remarks on result:
- no indication of irritation
- Remarks:
- Irritation was only checked at 24 and 72 hours.
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no irritation observed
- Remarks on result:
- no indication of irritation
- Remarks:
- Irritation was only checked at 24 and 72 hours.
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no irritation observed
- Remarks on result:
- no indication of irritation
- Remarks:
- Irritation was only checked at 24 and 72 hours.
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no irritation observed
- Remarks on result:
- no indication of irritation
- Remarks:
- Irritation was only checked at 24 and 72 hours.
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no irritation observed
- Remarks on result:
- no indication of irritation
- Remarks:
- Irritation was only checked at 24 and 72 hours.
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no irritation observed
- Remarks on result:
- no indication of irritation
- Remarks:
- Irritation was only checked at 24 and 72 hours.
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no irritation observed
- Remarks on result:
- no indication of irritation
- Remarks:
- Irritation was only checked at 24 and 72 hours.
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no skin irritation observed
- Remarks on result:
- no indication of irritation
- Remarks:
- Irritation was only checked at 24 and 72 hours.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no irritation observed
- Remarks on result:
- no indication of irritation
- Remarks:
- Irritation was only checked at 24 and 72 hours.
- Other effects:
- - Other adverse local effects: No
- Other adverse systemic effects: No
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an in vivo skin irritation study in rabbits according to OECD guideline 404 and GLP, no skin irritation was observed under the conditions of the study.
- Executive summary:
The test compound was tested undiluted in a primary skin irritation test in rabbits according to OECD 404 and GLP. No irritation could be observed after 24 and 72 hours under the conditions of the study. The index of primary irritations (mean of 24- and 72-hour values) was 0, therefore the compound is considered to be non-irritant. After 7 days, the skin of the animals was checked again and no signs of irritation was observed.
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