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

Acute Toxicity: oral

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

Test guideline 4

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

Test material information

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:

other: No clinical signs of systemic toxicity were noted.

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