[No public or meaningful name is available]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14 March 2018 - 18 May 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Test material form:

semi-solid (amorphous): gel

Results and discussion

Preliminary study:

Dose Level - 300 mg/kg: No mortalities

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 300 - <= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality @ 300 mg/kg
One animal killed for humare reasons @ 2000 mg.kg

Clinical signs:

other: Signs of systemic toxicity noted on Day 1, prior to termination were hunched posture, ataxia, pilo-erection, gasping respiration, vocalization and labored respiration.

Gross pathology:

Abnormalities noted at necropsy of the animal treated at a dose level of
2000 mg/kg, that was humanely killed, were patchy pallor of the liver, gaseous stomach and gaseous small intestine. No abnormalities were noted at necropsy of animals treated at a dose level of 300 mg/kg.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The acute oral median lethal dose (LDso) of the test item in the female Wistar strain rat was estimated to be in the range of 300 - 2000 mg/kg body weight.

Executive summary:

Introduction

 

The study was performed to assess the acute oral toxicity of the test item in the Wistar strain rat.

 

Methods

 

Following a sighting test at dose levels of 300 mg/kg and 2000 mg/kg, a further group of four fasted females was given a single oral dose of test item, as a suspension in arachis oil BP, at a dose level of 300 mg/kg body weight. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.

 

Results

 

Mortality.The animal treated at a dose level of 2000 mg/kg was killed for humane reasons, duetotheoccurrence ofclinicalsignsoftoxicitythatexceededtheseveritylimitsetforthin the UK Home Office Project License. There were no deaths noted at a dose levelof

300 mg/kg.

 

Clinical Observations.Signs of systemic toxicity noted in the animal treated at a dose level of 2000 mg/kg that was killed for humane reasons were hunched posture, pilo-erection gasping respiration, vocalization and labored respiration.

 

Hunched posture was noted during the day of dosing in animals treated at a dose level of 300 mg/kg.

 

Body Weight.Surviving animals showed expected gains in body weight.

 

Necropsy.Abnormalities noted at necropsy of the animal treated at a dose level of

2000 mg/kg, that was humanely killed, were patchy pallor of the liver, gaseous stomach and gaseous small intestine. No abnormalities were noted at necropsy of animals treated at a dose level of 300 mg/kg.