2-(4-bromo-3-hydroxy-2-quinolyl)-1H-indene-1,3(2H)-dione

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

october/november 1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-(4-bromo-3-hydroxy-2-quinolyl)-1H-indene-1,3(2H)-dione

EC Number:

233-701-7

EC Name:

2-(4-bromo-3-hydroxy-2-quinolyl)-1H-indene-1,3(2H)-dione

Cas Number:

10319-14-9

Molecular formula:

C18H10BrNO3

IUPAC Name:

2-(4-bromo-3-hydroxy-2-quinolyl)-1H-indene-1,3(2H)-dione

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

other: CFY

Sex:

male/female

Details on test animals or test system and environmental conditions:

Rats were of the CFY strain, in the weight range 88 to118g ans they were starved overnight before treatment with the tested substance.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

methylcellulose

Details on oral exposure:

The material was prepared as a 40% w/v suspension in aqueous methylcellulose (1%) and administered by oral intubation at a range of dosage volumes in the full scale testof 10 to 40 ml/kg bodyweight. Rats treated with the vehicle alone (40 ml/kg) served as controls.

Doses:

0 - 4.0 - 6.4 - 10 -16 g/kg

No. of animals per sex per dose:

5 males and 5 females

Control animals:

yes

Details on study design:

During the observation period of 14 days, a record was kept of all mortalities and sign of toxicity. All rats that died were examined macroscopically in an attempt to identify the target organs, and those animals surviving terminally weresimilarly examined to detect possible residual damage.

Results and discussion

Preliminary study:

The results of preliminary range finding test indicated that the median lethal oral dose (LD50) was in the region of 4.0 to 16 g/kg bodyweight.
Dosing was then extended to larger groups of rats (five males and five females) in order to locate the median lethal dose more precisely.

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 11 400 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 4 788 mg/kg bw

Based on:

act. ingr.

Mortality:

Death occured among rats treated at 4.0, 10 or 16 g/kg within 3 to 29 hours of dosing. Autopsy revealed congestion and haemorrhage of the lungs and pallor of the liver, spleen and kidneys.

Clinical signs:

other: Sign of reaction to treatment observed shortly after dosing, included lethargy, pilo-erection, abnormal body carriage (hunched posture), abnormal gait (waddling), ptosis and diarrhoea. These signs were accompanied by increased salivation and decreased res

Applicant's summary and conclusion

Interpretation of results:

other: not classified according to CLP regulation (EC 1272/2008)

Conclusions:

The LD50 is calculated to be 11.400 mg/kg tested materila or 4788 mg/kg active ingredient.

Executive summary:

The potential of the substance for acute toxicity following oral administration was tested in male and female rats of the CFY strain. 5 animals per sex per dose were tested at doses of 4000, 6400, 10000 and 16000 mg/kg bw and observed for 14 days.

Sign of reaction to treatment observed shortly after dosing, included lethargy, pilo-erection, abnormal body carriage (hunched posture), abnormal gait (waddling), ptosis and diarrhoea. These signs were accompanied by increased salivation and decreased respiratory rate amongst rats treated at 6.4 g/kg and above and by diuresis amongst rats at 10 to 16 g/kg.

Yellow colouration of the urine and faeces was noted for rats trated at 16 g/kg.

Death occured among rats treated at 4.0, 10 or 16 g/kg within 3 to 29 hours of dosing. Autopsy revealed congestion and haemorrhage of the lungs and pallor of the liver, spleen and kidneys.

 

Based on the active ingredient content, namely 4788 mg/kg bw, the test substance is not classified as acutely toxic by oral exposure route.