Registration Dossier
Registration Dossier
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EC number: 202-790-4 | CAS number: 99-82-1
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2/3 to 17/3 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: similar to guideline study, non-GLP and no individual data reported
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- p-menthane
- IUPAC Name:
- p-menthane
- Reference substance name:
- 1-isopropyl-4-methylcyclohexane
- EC Number:
- 202-790-4
- EC Name:
- 1-isopropyl-4-methylcyclohexane
- Cas Number:
- 99-82-1
- Molecular formula:
- C10H20
- IUPAC Name:
- 1-methyl-4-(propan-2-yl)cyclohexane
- Details on test material:
- - Name of test material (as cited in study report): p-menthane
- Physical state: liquid
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain: Wilmslow Wistar
- Source: Harlan Winkelmann GmbH, 33167 Borchen
- Age at study initiation: young adults
- Weight at study initiation: average 153 g
- Fasting period before study: 16 hours before application
- Housing: 5 animals/macrolon III cage
- Diet: R10 allein diät Ssniff laboratory rat feed ad libitum
- Water: ad libitum
- Acclimation period: 5 - 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±1
- Humidity (%): 60 ±5%
- Air changes (per hr):15/hr
- Photo period (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 02-03-1989 To: 17-03-1989
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE: NA
MAXIMUM DOSE VOLUME APPLIED: 3.75 cm³/kg bw - Doses:
- 3000 mg/kg bw
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical signs: until 6 hours and daily thereafter
Body weight:on day 0, 1, 7, 14
- Necropsy of survivors performed: yes
- Other examinations performed: macrocopic investigations - Statistics:
- NA limit test
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 3 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality
- Clinical signs:
- other: ventro-lateral recumbency, piloerection and diarrhea in males during first 24 hours.Thereafter, no observations.
- Gross pathology:
- thickening of the forestomach mucosa
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 in rats is >3000 mg/kg bw
- Executive summary:
In a limit test rats received 3000 mg/kg bw of the test substance. No mortality occurred. The LD50 is >3000 mg/kg bw.
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