Registration Dossier
Registration Dossier
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EC number: 246-115-1 | CAS number: 24271-12-3
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29 Aug - 27 Sep 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted in 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted in 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- adopted in 2002
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayrisches Landesamt für Gesundheit und Lebensmittelsicherheit, Schwabach, Germany
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Octadecyl docosanoate
- EC Number:
- 246-115-1
- EC Name:
- Octadecyl docosanoate
- Cas Number:
- 24271-12-3
- Molecular formula:
- C40H80O2
- IUPAC Name:
- octadecyl docosanoate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl:WI (Han) rats
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 - 10 weeks
- Weight at study initiation: step 1: 160 - 170 g; step 2: 164 - 179 g
- Fasting period before study: animals were fasted 16 - 19 h prior to administration
- Housing: group-caged in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding
- Diet: Altromin 1324 maintenance diet for rats and mice, ad libitum
- Water: tap water, sulphur acidified to a pH value of approx. 2.8, ad libitum (analysis were performed)
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.2 g/mL
- Amount of vehicle: 10 mL/kg bw
- Justification for choice of vehicle: non-toxic characteristic
- Lot/batch no.: MKCC0462
MAXIMUM DOSE VOLUME APPLIED: 10 mL
CLASS METHOD
- Rationale for the selection of the starting dose: no rationale given in the report - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 females per step (2 steps performed)
- Control animals:
- no
- Remarks:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: On the day of dosing animals were observed for general clinical signs, morbidity and mortality (at least once during the first 30 min and with more attention during the first 4 h, then once daily). Body weights were determined on Day 1 prior to dosing, on Day 8 and Day 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, macroscopical examination for grosspathological changes
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed during the study period.
- Clinical signs:
- No clinical signs were observed during the study period.
- Body weight:
- Normal body weight gain was observed in all animals (17 - 28% at the end of the study period).
- Gross pathology:
- No abnormal morphological findings were observed in any animal.
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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