coconut oil, reaction products with glycerol esters of 3,5-bis(1,1-dimethylethyl)-4-hydroxybenzenepropanoic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study (OECD, GLP, QAU)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted February 24, 1987

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

July 31, 1992

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

425-400-6

EC Name:

-

Cas Number:

179986-09-5

Molecular formula:

UVCB substance

IUPAC Name:

methyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoate; propane-1,2,3-triol; tetradecanoic acid

Details on test material:

- Physical state: liquid
- Analytical purity: 95%
- Storage condition of test material: room temperature, away from direct sunlight
No further information.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Switzerland
- Age at study initiation: males: 8 weeks, females: 10 weeks
- Weight at study initiation: males: 191-208.5 g, females: 175.1-184.3 g
- Fasting period before study: yes, overnight prior to application
- Housing: groups of five in Makrolon type-4 cages with standard softwood bedding
- Diet (ad libitum): pelleted standard Kliba 343
- Water (ad libitum): tap water
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

- Concentration in vehicle (if gavage): 0.2 g/ml

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: four times during day 1 and once daily during days 2-14, for changes in appearance and behaviour
- Frequency of weighing: day 1, 8, 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: based on mortality, clinical signs, body weight, gross pathology findings

Mortality:

No deaths occurred.

Clinical signs:

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

Gross pathology:

No findings.