Fatty acids, tall-oil, esters with trimethylolpropane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Study period:

24 Jan - 12 Feb 2002

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP-Guideline study with acceptable restrictions (no analytical purity data available)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

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

Version / remarks:

adopted in 1996

Deviations:

yes

Remarks:

no analytical purity reported

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

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

Version / remarks:

adopted in 1996

Deviations:

yes

Remarks:

no analytical purity reported

GLP compliance:

yes

Remarks:

Department of health of the government of the United Kingdom, UK

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

403507-18-6

EC Number:

609-825-6

Cas Number:

403507-18-6

IUPAC Name:

403507-18-6

Details on test material:

- Name of test material (as cited in study report): only trade name given
- Physical state: dark amber slightly viscous liquid
- Analytical purity: no data
- Storage condition of test material: room temperature in the dark

Test animals

Species:

rat

Strain:

other: Sprague-Dawley CD (Crl: CD IGS® BR)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd, Kent, UK
- Age at study initiation: approximately 8 weeks of age
- Weight at study initiation: 226 – 237 g (males) and 211 – 232 g (females)
- Fasting period before study: overnight immediately before dosing and for approximately three to four hours after dosing.
- Housing: three animals of the same sex per cage in solid-floor polypropylene cages furnished with wood flakes.
- Diet: Certified Rat and Mouse diet (Code 5LF2), PMI Nutrition International, Nottingham, UK, ad libitum (with exception to fasting period)
- Water: mains drinking water, ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): at least 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: 2.15 mL/kg

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

other: not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed daily for mortality or evident signs of toxicity ½, 1, 2, and 4 hours after dosing and thereafter for fourteen days. Individual body weights were determined prior to dosing and seven and fourteen days after exposure
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

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 toxicity were observed up to the end of the 14-day observation period.

Gross pathology:

Necropsy examination revealed no substance-related findings.

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