Registration Dossier
Registration Dossier
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EC number: 255-485-3 | CAS number: 41669-30-1
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03 - 20 Jan 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP-guideline study with acceptable restrictions. Lack of detail on test material.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- adopted in 1987
- Deviations:
- yes
- Remarks:
- lack of detail on test material
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Isooctadecyl isooctadecanoate
- EC Number:
- 255-485-3
- EC Name:
- Isooctadecyl isooctadecanoate
- Cas Number:
- 41669-30-1
- Molecular formula:
- C36H72O2
- IUPAC Name:
- 2-methylheptadecyl 3-methylheptadecanoate
- Details on test material:
- - Name of test material (as cited in study report): [only trade name given]
- Physical state: liquid
- Analytical purity: no data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: IFFA CREDO (L'Arbresle, FRANCE)
- Age at study initiation: 2 months old
- Weight at study initiation: 171.9 ± 3.3 g (males) and 159.8 ± 6.2 g (females)
- Fasting period before study: 16 hours
- Housing: 5 animals per sex were housed in Makrolon boxes (45.5 x 31 x 19 cm) whose floor was covered with soft wood sawdust (UAR 96360 Villemoison)
- Diet: feed UAR A04C, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): 14
- 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:
- other: not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed for clinical signs immediately after test item administration upto 3 h and then daily observations were made upto 14 days. Animals were also observed for mortality at least twice a day and were weighed on day 0, 3 , 7 and 14.
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality or clinical signs were observed at this dose level
- Mortality:
- There was no mortality during the study period.
- Clinical signs:
- other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.
- Gross pathology:
- Necropsy examination revealed no substance-related findings.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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