Registration Dossier
Registration Dossier
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EC number: 614-682-8 | CAS number: 68647-95-0
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:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
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 Dec. 2001
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted May 2008
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- adoopted Dec. 2002
- Qualifier:
- according to guideline
- Guideline:
- other: Japan MAFF Testing Guideline of 12 Nosan No. 8147
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Fatty acids, C18-unsatd., dimers, compds. with coco alkylamines
- EC Number:
- 614-682-8
- Cas Number:
- 68647-95-0
- Molecular formula:
- Not applicable (UVCB substance)
- IUPAC Name:
- Fatty acids, C18-unsatd., dimers, compds. with coco alkylamines
- Details on test material:
- - Name of test material (as cited in study report): Fatty acids, C18-unsatd., dimers, compds. with coco alkylamines
- Physical state: highly viscous amber liquid
- Analytical purity: The test item is a complex mixture of isomers and homologues components, so no purity can be stated. (For details see analytical report BASF study-No.: 11S05363)
- Purity test date: 2012-08-08
- Lot/batch No.: BI514173
- Expiration date of the lot/batch: 2013-04-18
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: app. 10 weeks
- Weight at study initiation: 175.7 - 203.7g
- Fasting period before study: 16h, water available ad lib.
- Housing: single in Makrolon type III cages
- Diet (e.g. ad libitum): VRF1(P) ad libitum; SDS Special Diets Services, 67122 Altrip, Germany
- Water (e.g. ad libitum): tap water ad lib.
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 30-70%
- Air changes (per hr): app. 10
- Photoperiod (hrs dark / hrs light): 12h/12h
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 2.22mL/kg b.w.
DOSAGE PREPARATION (if unusual): the test item was heated at 70°C for app. 1h for better handling, and administered luke warm - Doses:
- 2000
- No. of animals per sex per dose:
- 6 (in two experiments with 3 animals each)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: several times on the day of application, at least once daily on workdays thereafter
- Frequency of weighing: shortly before administration, weekly thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality occured
- Mortality:
- No mortality occured
- Clinical signs:
- other: In the first experiment, impaired general state and dyspnoe occured in all animals for up to 4h during the first day. Salivation right after application and piloerection (2h - 4h after application) was observed in two animals. The second test group showed
- Gross pathology:
- No abnormalities observed.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
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