Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
29 Apr - 13 May 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
(adopted in 1996)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Fatty acids, C18 unsat trimers di and triesters with 2-ethylhexanol
EC Number:
605-694-4
Cas Number:
173832-46-7
Molecular formula:
uvcb not available
IUPAC Name:
Fatty acids, C18 unsat trimers di and triesters with 2-ethylhexanol
Details on test material:
- Name of test material (as cited in study report): [trade name]
- Physical state/appearance: brown liquid
- Analytical purity: no data
- Batch No.: N558331
- Densitiy: 930 kg/m³
- Storage: room temperature, in the dark

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Strain as cited in study report: Wistar strain Crl:(WI) BR (outbred, SPF-Quality)
- Source: Charles River, Sulzfeld, Germany
- Age at study initiation: approx. 8 weeks old
- Mean weight at study initiation: 267 g (males); 177 g (females)
- Fasting period before study: yes (overnight)
- Housing: 3 per cage in polycarbonate cages
- Diet: standard pelleted laboratory animal diet (Carfil Quality BVBA, Out-Turnhout, Belgium); ad libitum
- Water: tap water; ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Animals were fasted overnight prior to dosing until approx. 3-4 hours after administration of the test substance.
Doses:
2000 mg/kg bw (2.15 mL/kg bw)
(Dose volume calculated as follows: dose level (g/kg) : densitiy (0.93 g/mL))
No. of animals per sex per dose:
- Group 1: 3 males
- Group 2: 3 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations: daily
- Frequency of weighing: day 1 (pre-administration), day 8 and day 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
No statistical analysis was performed.

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: LD50 experimental
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: LD50 cut-off according to OECD 423
Mortality:
No mortality occurred.
Clinical signs:
No clinical signs were observed during the study period.
Body weight:
The body weight gain was considered to be similar to that expected of normal untreated animals of the same age and strain.
Mean values (day 1; day 8; day 15):
- Group 1: 267 g; 326 g; 363 g
- Group 2: 177 g; 206 g; 223 g
Gross pathology:
No abnormalities were found at macroscopic post mortem examination of the animals.

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