Registration Dossier
Registration Dossier
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EC number: 629-757-0 | CAS number: 1224966-15-7
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Old report, non-GLP. Limited detail reported.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- No body weight recording; No addtional group of the other sex was dosed.
- GLP compliance:
- no
- Remarks:
- Pre-GLP; signed authentication form present
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Fatty acids, C18 unsaturated, reaction product with ammonia-ethanolamine reaction by-products
- EC Number:
- 629-757-0
- Cas Number:
- 1224966-15-7
- Molecular formula:
- UVCB, no structural formula can be set
- IUPAC Name:
- Fatty acids, C18 unsaturated, reaction product with ammonia-ethanolamine reaction by-products
- Details on test material:
- Name: BEROLAMINE AA15, a amide/imidazoline of Berolamine 20 and a fatty acid (Product name for Fatty acids, C18 unsaturated, reaction product with ammonia-ethanolamine reaction by-products)
Described: dark brown highly viscous liquid.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Bantin and Kipman Ltd; caesarian-derived, outbread SD
- Age at study initiation:
- Weight at study initiation: 121-145 g
- Fasting period before study: 16 hrs
- Housing: groups of 6 animals in suspended plastic cages
- Diet (e.g. ad libitum): expanded autoclaved small animal diet (Spratt's Lab. Diet No. 1); ad lib
- Water (e.g. ad libitum): source not specified; ad lib
- Acclimation period: 1 week for range finder; 3 weeks for main study.
ENVIRONMENTAL CONDITIONS: not indicated
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): constant volume of 20 ml/kgBW
- Concentration in vehicle: dose between 1.0 to 8 g/kgBW, thus concentration between 50 - 400 g/L
- Justification for choice of vehicle: Leads to acceptable emulsion
- Lot/batch no. (if required): not indicated
- Purity: not indicated
MAXIMUM DOSE VOLUME APPLIED: constant volume of 20 ml/kgBW - Doses:
- Range finder: 1 , 2, 4, 6, 8 g/kgBW
Main study: 2.25, 2.92, 3.80, 4.94, 6.42 g/kgBW - No. of animals per sex per dose:
- Range finder: 2 animals/group
Main study: 6 animals/group - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: not indicated. No BW measured
- Necropsy of survivors performed: yes/no
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Clinical signs at least daily. Macroscopic post mortem examination. - Statistics:
- LD50 calculated according to Thompson WR (1947) Bact. Reviews 11, 115.
Results and discussion
- Preliminary study:
- dose-range study with 5 dose levels: 1.0, 2.0, 4.0, 6.0 and 8.0 g/kgBW
At 1.0 and 2.0 g/kg no deaths occurred. At higher levels all animals died. (See table for further information)
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 4 000 mg/kg bw
- 95% CL:
- 3 400 - 4 800
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- LD50 = 4 g/kgBW
- Executive summary:
The acute oral toxicity of Berolamine AA15 was investigated in male Sprague Dawley rats. The Median Lethal Dose and its 95% confidence limits were calculated to be 4.0 (3.4 -4.8) g/kg. As such this material may be classified as category 5 for acute toxicity hazard (GHS).
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