Registration Dossier
Registration Dossier
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EC number: 204-677-5 | CAS number: 124-07-2
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Octanoic acid
- EC Number:
- 204-677-5
- EC Name:
- Octanoic acid
- Cas Number:
- 124-07-2
- Molecular formula:
- C8H16O2
- IUPAC Name:
- octanoic acid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Sultzfeld, Germany
- Age at study initiation: 7 weeks
- Weight at study initiation: males: 206-230 g; females: 170-181 g
- Fasting period before study: overnight (prior to dosing) until approximately 3.5 hours after administration
- Housing: individually in polycarbonate cages containing purified sawdust as bedding material
- Diet: standard pelleted laboratory animal diet (RMH-B, Hope Farms, Woerden, The Netherlands)
- Water: tap-water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21
- Humidity (%): 50 - 60
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for any signs of toxicity approximately once every two hours after dosing and once daily thereafter for 14 days. Individual bodyweights were measured weekly.
- Necropsy of survivors performed: Yes, at the end of the study (day 14), all animals were anaesthetised by CO2/O2 inhalation, subsequently killed by CO2 and subjected to necropsy
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: No signs of systemic toxicity were observed during the 14 day observation period.
- Gross pathology:
- Macroscopic examination of animals at termination revealed firm and/or small white/greyish irregular patches in the forestomach of all animals.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- CLP: not classified
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