Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
26 Aug 2003 - 11 Sep 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

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
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: JMAFF Japanese test guideline (Acute Oral Toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Fatty acids, C14-18 and C16-18-unsatd., mixed esters with castor oil, castor oil fatty acids, 2-ethylhexanoic acid and 2,2-bis(hydroxymethyl)-1-butanol
EC Number:
295-653-3
EC Name:
Fatty acids, C14-18 and C16-18-unsatd., mixed esters with castor oil, castor oil fatty acids, 2-ethylhexanoic acid and 2,2-bis(hydroxymethyl)-1-butanol
Cas Number:
92113-48-9
Molecular formula:
Not applicable, substance is a UVCB.
IUPAC Name:
Fatty acids, C14-18 and C16-18-unsatd., mixed esters with castor oil, castor oil fatty acids, 2-ethylhexanoic acid and 2,2-bis(hydroxymethyl)-1-butanol
Details on test material:
- Physical state: dark yellowish oily liquid
- Analytical purity: 80%
- Lot/batch No.:0600003317
- Expiration date of the lot/batch: 30 May 2004
- Stability under test conditions: stable
- Storage condition of test material: at room temperature in the dark
- Specific gravity: 0.94 g/cm³

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: mean 292 g (males), mean 202 g (females)
- Fasting period before study: overnight (for a maximum of 20 hours) prior to dosing until 3-4 hours after administration of the test substance
- Housing: in groups of three animals per sex per cage in MAcrolon cages (type VI; heigh 18 cm) containing purified sawdust as bedding material (SAWI, Jelu Werk, Rosenberg, Germany)
- Diet: standard pelleted laboratory animal diet (from Altromin (code VRF1), Lage, Germany); ad libitum
- Water (e.g. ad libitum): tap-water; ad libitum
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3 (acual range: 18.1 - 23.1)
- Humidity (%): 30 - 70 (actual range: 39 - 72)
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: 26 Aug 2003 To: 09 Sep 2003

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw (2.128 mL/kg bw)
Doses:
2000 mg/kg bw
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: Mortality/viability was checked twice daily. Checks for clinical signs were done at periodic intervals on the day of dosing (day 1) and once daily teherafter until day 15. Animals were weighed on days 1 (prior to doing), 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study period
Clinical signs:
No clinical signs of systemic toxicity were noted.
Body weight:
The body weights gain shown by the animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain.
Gross pathology:
No abnormalites were found.
Other findings:
- Other observations: Brown staining of the fur on the back and neck was observed in one female between days 9 and 12 and in one male between days 7 and 10.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
DSD: not classified
CLP: not classified