Registration Dossier
Registration Dossier
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EC number: 207-951-2 | CAS number: 502-72-7
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study predating GLP and modern guidelines, limited reporting, but sufficient to derive LD50.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
- Principles of method if other than guideline:
- Cyclopentadecanone was administered dermally at the limit dose of 5000 mg/kg bw to 10 rabbits. Animals were observed for 14 days for mortality and clinical signs.
- GLP compliance:
- no
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Cyclopentadecanone
- EC Number:
- 207-951-2
- EC Name:
- Cyclopentadecanone
- Cas Number:
- 502-72-7
- Molecular formula:
- C15H28O
- IUPAC Name:
- cyclopentadecanone
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 75-20
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 10/dose (sex unspecified)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs - Statistics:
- Not applied.
Results and discussion
Effect levels
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- One rabbit out of 10 died on day 6 post-application.
- Clinical signs:
- Slight or moderate redness was observed in 2 and 2 rabbits out of 10, respectively. Slight edema was noted in 3 out of 10 animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of the study, acute dermal LD50 of cyclopentadecanone is > 5000 mg/kg bw.
- Executive summary:
In the study predating GLP and OECD guidelines, cyclopentadecanone of unspecified purity was administered to 10 rabbits of unspecified sex and strain via dermal route. Animals were observed for 14 days for mortality and clinical signs. There was one death at day 6. Clinical signs were limited to slight or moderate erythema in 4 out of 10, and slight edema in 3 out of 10 rabbits. Based on the results of the study, acute dermal LD50 of cyclopentadecanone exceeds 5000 mg/kg bw.
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