Registration Dossier

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:
2014
Report Date:
2014

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
GROUPE INTERMINISTERIEL DES PRODUITS CHIMIQUES
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

Test animals

Species:
rat
Strain:
other: Sprague Dawley (SPF Caw)
Sex:
female
Details on test animals 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:
No clinical signs related to toxicity were observed during the study.
Body weight:
Body weight gain appeared normal until the end of the observation period.
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