Glycerides, tallow sesqui-, hydrogenated, propoxylated

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25 March 1998 - 21 April 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

24 February 1997

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

1

Reference substance name:

Glycerides, tallow sesqui-, hydrogenated, propoxylated

EC Number:

614-598-1

Cas Number:

68553-12-8

Molecular formula:

n/a

IUPAC Name:

Glycerides, tallow sesqui-, hydrogenated, propoxylated

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

Five/sex

Control animals:

no

Results and discussion

Preliminary study:

One male and one female rat was administered the substance via oral gavage at a dose of 2000 mg/kg bw. There were no clinical toxicity or mortality. Based on this inforamtion a dose of 2000 mg/kg bw was chosen for the main study.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

One female was found dead two days after dosing.

Clinical signs:

other: No signs of systemic toxicity (except for the dead female) was observed.

Gross pathology:

Abnormalities noted at necropsy of the dead female included haemorrhagic lungs, dark liver, pale spleen, dark kidneys, pale gastric mucosa and gaseous distension of the stomach and large intestines. No abnormalities were noted of the animals terminated at the end of the study.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 is >2000 mg/kg bw.

Executive summary:

In an acute toxicity study the substance was administered to Sprague Dawley rats (5 animals/sex/dose) by oral gavage at a dose level of 2000 mg/kg bw (single administration). One female was found dead two days after dosing. Abnormalities noted at necropsy of the dead female included haemorrhagic lungs, dark liver, pale spleen, dark kidneys, pale gastric mucosa and gaseous distension of the stomach and large intestines. This was attributed to misadministration. No abnormalities were noted of the other animals terminated at the end of the study. There were no other signs of clinical toxicity, mean body weight gain was as expected. The oral LD50 is >2000 mg/kg bw.