Registration Dossier
Registration Dossier
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EC number: 204-793-6 | CAS number: 126-57-8
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: Recent GLP study according to international guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 2-ethyl-2-[[(1-oxononyl)oxy]methyl]propane-1,3-diyl dinonan-1-oate
- EC Number:
- 204-793-6
- EC Name:
- 2-ethyl-2-[[(1-oxononyl)oxy]methyl]propane-1,3-diyl dinonan-1-oate
- Cas Number:
- 126-57-8
- Molecular formula:
- C33H62O6
- IUPAC Name:
- 2,2-bis[(nonanoyloxy)methyl]butyl nonanoate
- Test material form:
- other: liquid
- Details on test material:
- -Physical state: liquid
- Analytical purity: on sponsor responsability
- Lot/batch No.: P_F54 and P_ MAGGIO 2013
- Expiration date of the lot/batch: 2014-11-30
- Stability under test conditions: on sponsor responsability
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Italy s.r.l, San Pietro al Natisone (UD) Italy
- Age at study initiation: 7 weeks old
- Weight at study initiation: 157-163 grams
- Fasting period before study: food was removed from the cage overnight prior to dosing
- Housing:Polisulphone solid bottomed cage measuring 59,5x38x20 cm with nesting material provided into suitable bedding bags
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +- 2°C
- Humidity (%): 55% +- 15%
- Air changes (per hr): 15 to 20/ hour
- 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: 200mg/mL
MAXIMUM DOSE VOLUME APPLIED: 10mL/kg - Doses:
- 2000mg/kg
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 2x/day
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality occured
- Clinical signs:
- other: no clinical signs were observed in the 2 groups of animals initially dosed at 2000mg/kg
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Acute toxicity for Trimethylolpropane Tripelargonate is expected to be greater than 2000 mg/kg body weight.
- Executive summary:
The acute toxicity of Trimethylolpropane Tripelargonate was investigated following a single oral administration to the Sprague Dawley rat followed by a 14-day observation period. A first group of 3 female animals was initially dosed at 2000 mg/kg (Step 1). No mortality occurred and no clinical signs were observed. A second group of 3 female animals was then dosed at the same dose level (Step 2). No death occurred and no clinical signs were noted. Body weight changes recorded during the study were within the expected range for this strain and age of animals. No abnormalities were observed at necropsy examination performed at the end of the observation period on animals of both groups. These results indicate that the test item Trimethylolpropane Tripelargonate did not induce toxic effects in the rat following oral administration of a single dose at a level of 2000 mg/kg. The lack of mortality demonstrates the acute toxicity expected (ATE) to be greater than 2000 mg/kg body weight. European Directives concerning the classification, packaging and labelling of dangerous substances (Council Regulation (EC) No. 1272/2008 and subsequent revisions) would indicate the following:
- Classification: not required
- Signal word: not required
- Labeling: not required
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