Registration Dossier
Registration Dossier
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EC number: 616-261-4 | CAS number: 75782-87-5
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Alcohols, C14-16
- EC Number:
- 269-790-4
- EC Name:
- Alcohols, C14-16
- Cas Number:
- 68333-80-2
- IUPAC Name:
- pentadecan-1-ol
- Details on test material:
- Tradename Isalchem 145 C14-16 alcohols Type A. Equivalent to Alcohols, C14-15-branched and linear (no CAS).
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: 200 g (+- 20g)
- Fasting period before study:
- Housing: transparent polycarbonate cages, 5 animals per cage
- Diet: pelleted complete diet
- Water: filtered tap water, ad libitum
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-1
- Humidity (%): 55 +/-15
- Air changes (per hr): min. 8
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- undiluted
- Details on oral exposure:
- Not reported.
- 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 signs and mortality several times during day 1 after dosing and daily thereafter. Survivors were weighed at the end of the observation period.
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- No animals died.
- Clinical signs:
- other: No signs of intoxication.
- Gross pathology:
- Unremarkable.
- Other findings:
- POTENTIAL TARGET ORGANS: None identified.
SEX-SPECIFIC DIFFERENCES: None.
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 Isalchem 145 was >5000 mg/kg. There were no clinical signs of intoxication and findings at gross autopsy were unremarkable.
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