5-[(4-chloro-2-nitrophenyl)azo]-1-ethyl-1,2-dihydro-6-hydroxy-4-methyl-2-oxonicotinonitrile

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Experiment start date: 06 December 1979; Experiment end date: 04 February 1980; Study completion date: 07 March 1980.

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

5-[(4-chloro-2-nitrophenyl)azo]-1-ethyl-1,2-dihydro-6-hydroxy-4-methyl-2-oxonicotinonitrile

EC Number:

274-660-5

EC Name:

5-[(4-chloro-2-nitrophenyl)azo]-1-ethyl-1,2-dihydro-6-hydroxy-4-methyl-2-oxonicotinonitrile

Cas Number:

70528-90-4

Molecular formula:

C15H12ClN5O4

IUPAC Name:

5-[(4-chloro-2-nitrophenyl)diazenyl]-1-ethyl-6-hydroxy-4-methyl-2-oxo-1,2-dihydropyridine-3-carbonitrile

Test material form:

other: solid

Specific details on test material used for the study:

Name: FAT 36091/D
Purity: 50.2 %

Test animals

Species:

rat

Strain:

other: Tif:RAIf (SPF) strain

Sex:

male/female

Details on test animals or test system and environmental conditions:

Healthy random bred rats of the Tif: RAIf (SPF) strain (7 to 8 weeks old) raised on the premises were used for these experiments. They were kept at a room temperature of 22 + 2 °C, at a relative humidity of 55 + 10 % and on a 10 hours light cycle day. They received ad libitum rat food - NAFAG, Gossau SG - and water. During the treatment and observation period the animals were housed in groups of 5 in Macrolon cages (type 3), individually marked with picric acid.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

2% (w/v) in dist. water.

Details on oral exposure:

VEHICLE
Volume (ml/kg body-weight): 20

The test item was suspended to achieve the corresponding dosage level. Before treatment the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer.

Doses:

5000, 7000, 8000 and 10000 mg/kg.

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Bodyweights were recorded immediately prior to dosing (control weights) and at 7 and 14 days
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight.

Treatment and observations
Animals fasted overnight were treated by single oral intubation. Physical condition and rate of deaths were monitored throughout the whole observation period.

Statistics:

LD50 inclusing 95 % confidence limits are calculated by the logit model.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 8 000 mg/kg bw

Based on:

test mat.

Mortality:

At 5000 mg/kg: No deaths observed.
At 7000 mg/kg: 1 male died
At 8000 mg/kg: 2 male and 3 female died
At 10000 mg/kg: 3 male and 2 female died

Clinical signs:

other: - Sedation, dyspnoea, ruffled fur, diarrhoea, body position curved were observed at 5000 mg/kg. The surviving animals recovered within 7 days. - Sedation, dyspnoea, ruffled fur, diarrhoea, body position curved were observed at 7000 mg/kg. The surviving an

Gross pathology:

No substance related gross organ changes were seen.

Other findings:

No data

Any other information on results incl. tables

Body weight changes:

	Dose (mg/kg)
		5000	7000	8000
Day 1 Male	Mean body weight/SD (g)	208/18.4	185/14.2	188/9.0	188/11.4
Day 1 female	Mean body weight/SD (g)	180/8.3	180/5.9	174/7.3	173/4.6
Day 7 Male	Mean body weight/SD (g)	243/23.4	239/16.7	220/10.0	247/11.3
Day 7 female	Mean body weight/SD (g)	205/13.6	198/8.6	193/10.6	195/.0.
Day 14 Male	Mean body weight/SD (g)	290/25.5	280/21.9	261/12.9	293/20.5
Day 14 female	Mean body weight/SD (g)	237/27.8	212/3.8	223/15.6	218/8.1

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral LD50 of FAT 36091/D in rats of both sexes observed over a period of 14 days is approximately 8000 mg/kg.

Executive summary:

A study was conducted according to method similar or equivalent to OECD TG 401 to determine the acute oral toxicity of the test on rats via oral route. 5 males and 5 females were given following doses; 5000, 7000, 8000, 10000 mg/kg bw. Physical condition and rate of deaths were monitored throughout the whole observation period. Doses of 5000 to 10000 mg/kg bw was given by oral gavage. Before administration, the test item was prepared in CMC (Carboxymethyl cellulose).

Mortality;

At 5000 mg/kg: No deaths observed.

At 7000 mg/kg: 1 male died

At 8000 mg/kg: 2 male and 3 female died

At 10000 mg/kg: 3 male and 2 female died

Symptoms were observed in all dose levels: Sedation, dyspnoea, ruffled fur, diarrhoea, body position curved. The surviving animals recovered within 7 to 8 days. The acute oral LD50 of FAT 36091/D in rats of both sexes observed over a period of 14 days is approximately 8000 mg/kg.