Registration Dossier
Registration Dossier
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EC number: 247-987-6 | CAS number: 26762-92-5
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12/04 to 11/05 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline study under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- p-menthane hydroxyperoxide
- IUPAC Name:
- p-menthane hydroxyperoxide
- Reference substance name:
- Menthane, monohydroperoxy derivative
- EC Number:
- 247-987-6
- EC Name:
- Menthane, monohydroperoxy derivative
- Cas Number:
- 26762-92-5
- Molecular formula:
- C10H20O2
- IUPAC Name:
- menthane, monohydroperoxy derivative
- Details on test material:
- - Name of test material (as cited in study report): p-menthane hydroperoxide
- Physical state: liquid
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: Hsd/Win:WU
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, 33167 Borchen
- Age at study initiation: young adults
- Weight at study initiation: Males 148-184 g; Females 131-144
- Fasting period before study: 16 hours before application until 3 hours after application
- Housing: 5 animals/macrolon III cage
- Diet: Ssniff standard laboratory rat feed ad libitum
- Water: ad libitum
- Acclimation period: > 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 30-70%
- Air changes (per hr):15/hr
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 12-04-1994 To: 11-05-1994
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 2.2 mL/kg bw
- Doses:
- 2000 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 at 0.5, 1, 2 ,3, 4, 5, 6 hours post dosing and daily thereafter for 14 days
body weight on day 0, 7 and 14
- Necropsy of survivors performed: yes, macroscopic examination - Statistics:
- not applicable
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- none
- Clinical signs:
- other: Males: abnormal gait, hunched posture ,flat body posture, ventro-lateral recumbency, piloerection, ataxia, diarrhea hypothermia in all males until day 4 abnormal gait, hunched posture and piloerection persisting in one male until day 14 Females: abnorma
- Gross pathology:
- adhesions of abdominal organs to the peritoneum and cartilage like thickening of peritoneum
gastrointestrinal tract adhesions
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD50 > 2000 mg/kg bw
- Executive summary:
Rats received the test substance at 2000 mg/kg bw by oral gavage. No mortality was observed. The oral LD50 is > 2000 mg/kg bw.
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