DCHA-isostearate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

06.07.2010 - 27.07.2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Doses:

2000 mg/kg b.w. and 300 mg/kg b.w.

No. of animals per sex per dose:

2000 mg/kg: 3 females
300 mg/kg: 6 femals

Control animals:

no

Details on study design:

The test item was administered in a first step to a group of 3 female Sprague Dawley rats at the single dose of 2000 mg/kg body weight and in a second step to a group of 6 female Spague Dawley rats at the single dose of 300 mg/kg body weight

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 300 - < 2 000 mg/kg bw

Based on:

test mat.

Mortality:

It was noted the death of 3 rats treated at 2000 mg /kg b.w. at 3 hours (2/3) and at 23 hours 50 minutes post-dose (1/3).
No mortality occurred in the animals treated at 300 mg/kg b.w.

Clinical signs:

The mortalities were preceded by a decrease in spontanous activity (2/3), in Preyer's reflex (2/3), in body temperature (2/3) and in muscle ton (2/3), a bradypnea (1/3), a mydriasis (2/3), tremors (1/3), a partial ptosis (1/3) and an increases lachrymation (1/3).
No clinical signs related to the administration of the test item at 300 mg/kg b.w. were observed. Indeed, only a decreas in spontaneous activity was noted in one animal (1/6) at 3 hours post-dose. The animal recovered a normal behaviour at 24 hours post-dose.

Body weight:

A decrease was noted on the body weight of the animal that died at 23 hours 50 minutes post-dose: -7% compared to day 0.
Treatment at 300 mg/kg b.w.: The body weight evolution of the animals remained normal throughout the study.

Gross pathology:

Treatment at 2000 mg/kg b.w.: The macroscopical examination of the dead animals revealed a thinning of the forestomach (3/3), associated with a white coloration (2/3), red spots on the corpus (2/3) and a white thinning of the corpus (1/3).
Treatment at 300 mg/kg b.w.:: The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

in conclusion, the LD50 of the test item is higher than 300 mg/kg body weight and lower than 2000 mg/kg body weight by oral route in the rat.
In accordance with the OECD guideline No 423, the LD50 cut off of the test item may be considered as 500 mg/kg body weight by oral route in the rat.