Fatty acids, C9, hexaesters with dipentaerythritol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

up-and-down procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C5-9, hexaesters with dipentaerythritol

EC Number:

267-021-7

EC Name:

Fatty acids, C5-9, hexaesters with dipentaerythritol

Cas Number:

67762-52-1

Molecular formula:

Not defined because UVCB

IUPAC Name:

Fatty acids, C5-9, hexaesters with dipentaerythritol

Test material form:

liquid: viscous

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

unchanged (no vehicle)

Doses:

single dose level of 5000 mg/kg

No. of animals per sex per dose:

3 female

Control animals:

no

Details on study design:

Initially, one healthy female Sprague Dawley rat was dosed orally at 5000 mg/kg bw. Since the animal survived, two additional animals were similarly dosed. The rats were observed at 15 min, 1, 2 and 4 h post-dose, then once daily for 14 d for toxicity and pharmacological effects. All animals were observed twice daily for mortality. Bodyweights were recorded pre-test, weekly and at termination. All animals were observed for gross pathology.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

no mortality observed

Clinical signs:

other: one animal briefly had dhiarrea on Day 0

Gross pathology:

none

Other findings:

none

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the study conditions, the acute oral LD50 in female rats was > 5000 mg/kg bw.

Executive summary:

A study was conducted to evaluate the acute oral toxicity of the test substance according to OECD Guideline 425, in compliance with GLP. Initially, one healthy female Sprague Dawley rat was dosed orally at 5000 mg/kg bw. Since the animal survived, two additional animals were similarly dosed. The rats were observed at 15 min, 1, 2 and 4 h post-dose, then once daily for 14 d for toxicity and pharmacological effects. All animals were observed twice daily for mortality. Bodyweights were recorded pre-test, weekly and at termination. All animals were observed for gross pathology. All animals survived to study end. One animal briefly had diarrhoea on Day 0; there were no additional abnormal physical signs observed. Two animals gained weight and one animal lost weight between Days 7 and 14. The gross necropsy of all animals revealed no observable abnormalities. Under the study conditions, the acute oral LD50 in female rats was > 5000 mg/kg bw (Unnamed, 2012).