Registration Dossier
Registration Dossier
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EC number: 939-237-8 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1111
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 1981
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Alcohols, C6-12
- EC Number:
- 271-642-9
- EC Name:
- Alcohols, C6-12
- Cas Number:
- 68603-15-6
- IUPAC Name:
- octan-1-ol
- Details on test material:
- Tradename Lial 111 Type A
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Nossan-Correzzana, Milan, Italy
- Weight at study initiation: 200g (+- 20 g)
- Fasting period before study: fasted
- Housing:
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):
IN-LIFE DATES: From: To:
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- undiluted
- Doses:
- 5000 mg/kg
- No. of animals per sex per dose:
- 5M, 5F
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations made at frequent intervals on the day of dosing then daily. Body weights were recorded at the end of the observation period and compared to controls.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- All animals survived to the end of the 14 day observation period.
- Clinical signs:
- None observed.
- Body weight:
- There were no adverse effects on bodyweight.
- Gross pathology:
- None reported.
- Other findings:
- No target organs identified, no sex-specific differences detected.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The rat oral LD50 for Lial 111 is >5000 mg/kg. There were no signs of toxicity.
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