Registration Dossier
Registration Dossier
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EC number: 232-102-8 | CAS number: 7786-67-6
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 008
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 434 (Acute Dermal Toxicity - Fixed Dose Procedure)
- GLP compliance:
- no
- Test type:
- fixed dose procedure
Test material
- Reference substance name:
- Isopulegol
- EC Number:
- 201-940-6
- EC Name:
- Isopulegol
- Cas Number:
- 89-79-2
- IUPAC Name:
- 2-isopropenyl-5-methylcyclohexanol
- Reference substance name:
- 5-methyl-2-(1-methylvinyl)cyclohexan-1-ol
- EC Number:
- 232-102-8
- EC Name:
- 5-methyl-2-(1-methylvinyl)cyclohexan-1-ol
- Cas Number:
- 7786-67-6
- Molecular formula:
- C10H18O
- IUPAC Name:
- 5-methyl-2-(prop-1-en-2-yl)cyclohexan-1-ol
- Details on test material:
- Name of test material: L-Isopulegol
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- occlusive
- Details on dermal exposure:
- The skin was abraded in one animal/sex of each dosage group.
- Duration of exposure:
- The test sites were occluded for 24 h with a dental dam.
Observations were made 24 h after dosing and daily thereafter for 14 days. - Doses:
- A single 24-h, dermal application of neat isopulegol at 1.25, 2.5, 5.0 and 10 ml/kg/body weight (1.25, 2.5, 5 and 10.0 g/kg/body weight).
- No. of animals per sex per dose:
- 2
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 3 000 mg/kg bw
- Mortality:
- At 5 ml/kg, death occurred in one abraded female rabbit at 24 h; the remaining three rabbits surviving the 5.0 ml/kg dose exhibited ataxia.
At 10 ml/kg all the animals died, with two males dead at 24 h and two females at 48 h. - Gross pathology:
- Gross pathologic findings consisted of hyperemia of the stomach and post mortem change.
Gross necropsy of the surviving animals revealed dehydration and hemorrhage involving the dermis and epidermis
Applicant's summary and conclusion
- Conclusions:
- The acute dermal LD50 in rabbits was determined to be approximately 3000 mg/kg of body weight
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