Registration Dossier
Registration Dossier
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EC number: 700-316-5 | CAS number: 1155405-88-1
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January to February 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
Test material
- Reference substance name:
- Tri-C18-22 (even numbered)-alkyl 2-hydroxypropane-1,2,3-tricarboxylate
- EC Number:
- 700-316-5
- Cas Number:
- 1155405-88-1
- Molecular formula:
- HO-C(CH2COOR)2COOR R= -C18H37 or -C20H41 or -C22H45
- IUPAC Name:
- Tri-C18-22 (even numbered)-alkyl 2-hydroxypropane-1,2,3-tricarboxylate
- Reference substance name:
- 1155405-88-1
- Cas Number:
- 1155405-88-1
- IUPAC Name:
- 1155405-88-1
- Details on test material:
- - Name of test material (as cited in study report): Softenol 3352
- Substance type: product
- Physical state: white powder
- Stability under test conditions: not indicated
- Storage condition of test material: at room temperature in the dark
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: approx. 9 weeks
- Weight at study initiation: 213-243 g females (mean: 235 g), 285-340 g males (mean: 309 g)
- Fasting period before study: overnight (for a maximum of 20 h)
- Housing: group housing of 3 animals per sex per cage in Macrolon cages (type IV, height 15 cm), containing purified sawdust
- Diet (e.g. ad libitum): standard pelleted laboratory animal diet ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least for 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES:
Females: From: 24-JAN-01 To: 07-FEB-01
Males: From 26-JAN-01 To: 09-FEB-01
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Remarks:
- (specific gravity 1.036)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: w/w
- Amount of vehicle (if gavage): adjustment was made for the specific gravity of the vehicle, no further details mentioned
- Justification for choice of vehicle: the vehicle was selected based on a pretest, no further details mentioned
- Lot/batch no. (if required): no data
- Purity: no data
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: no data - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
Results and discussion
Effect levels
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
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