Fatty acids, C16-18 (even numbered) and C18-unsatd., branched and linear, di- and triesters with trimethylolpropane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

03 June - 17 June 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

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

limited data on test substance

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

limited data on test substance

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 C18-unsatd., branched and linear, esters with trimethylolpropane

EC Number:

284-956-6

EC Name:

Fatty acids, C14-18 and C18-unsatd., branched and linear, esters with trimethylolpropane

Cas Number:

85005-23-8

IUPAC Name:

85005-23-8

Details on test material:

- Name of test material (as cited in study report): fatty acids, C14-C18 and C18 unsaturated, branched and linear, esters with trimethylolpropane
- Physical state: yellow liquid
- Analytical purity: not indicated, treated as 100% pure
- Lot/batch No.: N558876
- Stability under test conditions: stable

Test animals

Species:

rat

Strain:

other: Wistar Crl:(WI) BR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Age at study initiation: 6 weeks
- Weight at study initiation: variation did not exceed less than 20% of the sex mean, not further specified
- Housing: groups of 3 animals in polycarbonate cages
- Fasting period before study: overnight prior to until 3 h after dosing
- Diet: pelleted standard laboratory animal diet; Carfil Quality BVBA, Belgium, ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50
- Air changes (per hr): 15
- 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: 2.17 mL/kg (calculated as dose level (2000 mg/kg)/density (0.92 g/mL))

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: observations: twice daily; weighing: Days 1, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: gross pathology

Statistics:

Not analysed

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality was observed during the study period.

Clinical signs:

other: No clinical signs were observed during the study period.

Gross pathology:

No abnormalities were observed in pathology.

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