Linseed oil, ester with pentaerythritol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

Not mentioned on study report

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Remarks:

Secondary literature source (documentation insufficient for assessment)

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

yes

Test type:

other: Acute oral toxicity

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Linseed oil, ester with pentaerythritol

EC Number:

271-985-4

EC Name:

Linseed oil, ester with pentaerythritol

Cas Number:

68648-28-2

Molecular formula:

UVCB

IUPAC Name:

2,3-dihydroxypropyl (7E,10E,13E)-hexadeca-7,10,13-trienoate; bis(3-[(7E,10E,13E)-hexadeca-7,10,13-trienoyloxy]-2-hydroxypropyl (9E)-octadec-9-enoate); 3-hydroxy-2-(hydroxymethyl)-2-[(octadec-9-enoyloxy)methyl]propyl (9E,12E,15E)-octadeca-9,12,15-trienoate; 3-hydroxy-2-{[(9E)-octadec-9-enoyloxy]methyl}-2-{[(9E,12E)-octadeca-9,12-dienoyloxy]methyl}propyl (9E,12E,15E)-octadeca-9,12,15-trienoate

Test material form:

liquid

Specific details on test material used for the study:

Test substance: Linseed oil, ester with pentaerythritol
CAS number: 68648-28-2
Purity: not indicated

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 49-74 d old
- Weight at study initiation: 222-235 g (males), 21l-229 g (females)
- Fasting period before study: Overnight
- Diet (e.g. ad libitum): yes
- Water (e.g. ad libitum): yes

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

2000 mg/kg (dosing volume 2 ml/kg, undiluted)

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

Five male and 5 female Sprague-Dawley rats were fasted overnight and dosed by oral gavage with 2000 mglkg body weight of the test material. No controls; feeding and water ad libitum hour after dosing.

Statistics:

None required

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality

Clinical signs:

other: No clinical signs of toxicity were observed in any of the female or male rats.

Gross pathology:

No abnormalities or gross lesions were observed at necropsy.

Other findings:

Clinical observations and necropsy observations were normal.

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Conclusions:

Under the study conditions, the LD50 was determined to be >2000 mg/kg bw.

Executive summary:

A study was conducted to determine the acute oral toxicity of the test substance according to OECD Guideline 401, in compliance with GLP. Five male and five female Sprague-Dawley rats were fasted overnight and dosed by oral gavage with 2000 mg/kg bw of the substance. No controls, feeding and water ad libitum hour after dosing. Observations for mortality and clinical manifestations were carried out daily for 14 d. Observations included changes in skin and fur, eyes and mucous membranes, and respiratory, circulatory, autonomic and central nervous system and somatomotor activity and behaviour pattern. Attention was directed to observations of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma. No mortality or clinical signs of toxicity were observed in any of the female or male rats. There were no treatment-related body weight changes. No abnormalities or gross lesions were observed at necropsy. Clinical observations and necropsy observations were normal. Under the study conditions, the LD50 was determined to be >2000 mg/kg bw (US EPA HPV, 2004).