Registration Dossier
Registration Dossier
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EC number: 305-769-9 | CAS number: 95009-41-9
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01 Apr - 16 Apr 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- GROUPE INTERMINISTERIEL DES PRODUITS CHIMIQUES
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Fatty acids, vegetable-oil, esters with dipropylene glycol
- EC Number:
- 305-769-9
- EC Name:
- Fatty acids, vegetable-oil, esters with dipropylene glycol
- Cas Number:
- 95009-41-9
- Molecular formula:
- not available (UVCB)
- IUPAC Name:
- Fatty acids, vegetable-oil, esters with dipropylene glycol
- Details on test material:
- - Name of test material (as cited in study report): Fatty acids, vegetable-oil, esters with dipropyleneglycol
- Physical state: liquid
- Analytical purity: 100% (UVCB)
- Lot/batch No.: ES 110680
- Expiration date of the lot/batch: 25 October 2016
- Storage condition of test material: at room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Sprague Dawley (SPF Caw)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage JANVIER Labs, Le Genest St Isle, France
- Age at study initiation: 8 weeks
- Weight at study initiation: 182 - 201 g
- Fasting period before study: animals were fasted 1 day prior to substance administration until 4 hrs after substance administration (diet only).
- Housing: 3 animals per cage in solid-bottomed clear polycarbonate cages with stainless steel mesh lids
- Diet: A04, SAFE, Augy, France
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 2.19 mL/kg bw
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 (including 1 animal from the sighting study and 4 additional animals in the main study)
- Control animals:
- other: 4 animals received 10 mL distilled water/kg bw via gavage in an additional study performed from 07 Jan - 21 Jan 2014.
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed 0.5, 1, 3 and 4 h after substance administration and daily thereafter; individual body weights were determined on Day 0 (prior to substance administration), 2, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: systematic examinations to identify any behavioural or toxic effects, macroscopical examination of oesophagus, stomach, duodenum, jejunum, ileon, caecum, colon, rectum, spleen, liver, thymus, trachea, lungs, heart, kidneys, urinary bladder, ovaries, uterus, adrenals and pancreas
Results and discussion
- Preliminary study:
- No mortality or clinical signs related to toxicity were observed in the female exposed in the sighting study. Therefore, 4 additional animals were exposed to the test substance in a second step.
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study.
- Clinical signs:
- other: No clinical signs related to toxicity were observed during the study.
- Gross pathology:
- No macroscopic changes were observed after treatment with the test substance.
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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