Reaction mass of 5-[[4-[benzylmethylamino]phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium methyl sulphate and 3-[[4-[benzylmethylamino]phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium methyl sulphate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27 May, 1980 to 23 June, 1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Justification for type of information:

None

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 applicable

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Diethyl sulphate, compound with N-methyl-N-[4-[(1-methyl-1H-1,2,4-triazol-5-yl)azo]phenyl]benzylamine (1:1)

EC Number:

263-444-6

EC Name:

Diethyl sulphate, compound with N-methyl-N-[4-[(1-methyl-1H-1,2,4-triazol-5-yl)azo]phenyl]benzylamine (1:1)

Cas Number:

62163-53-5

Molecular formula:

C17H18N6.C2H6O4S

IUPAC Name:

diethyl sulfate - N-benzyl-N-methyl-4-[(1-methyl-1H-1,2,4-triazol-5-yl)diazenyl]aniline (1:1)

Test material form:

liquid

Specific details on test material used for the study:

None

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 experiment. 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. Prior to treatment the animals were adapted to our laboratories for a minimum of 4 days.

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:

polyethylene glycol

Remarks:

polyethylene glycol (PAG 400), Fluka AG, Buchs SG, Art. 81170

Details on oral exposure:

FAT 31015/F was diluted to achieve the corresponding dosage level.
Volume (ml/kg body-weight): 10, 20

Doses:

1000, 1500, 2000 and 3000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

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.

Body weights:
Bodyweights were recorded immediately prior to dosing (control weights) and at 7 and 14 days.

Autopsies:
Surviving animals were submitted to a necropsy whenever they died, survivors at the end of the observation period.

Statistics:

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

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 635 mg/kg bw

Based on:

test mat.

95% CL:

>= 1 377 - <= 1 898

Mortality:

No mortality was observed in the rats treated at 1000 mg/kg bw. However, 1 male + 3 females and 4 males + 4 females were found dead at 1500 and 2000 mg/kg bw respectively. While, all the males and females treated at 3000 mg/kg bw were found dead.

Clinical signs:

other: The surviving animals recovered within 8 to 9 days. Sedation, dyspnoea, exophthalmos, ruffled fur, diarrhoea, curved body position and tremors were clinical signs observed at the tested dose levels.

Gross pathology:

No substance related gross organ changes were seen.

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral LD50 of FAT 31016/F in rats of both sexes observed over a period of 14 days was 1635 (1377-1898) mg/kg bw

Executive summary:

The acute oral LD50 of FAT 31016/F was evaluated in a study conducted with the methodology similar to OECD Guideline 401. Groups of male and female rats (5 each) were administered with the test substance at doses of 1000, 1500, 2000 and 3000 mg/kg bw. No mortality was observed in the rats treated at 1000 mg/kg bw. However, 1 male + 3 females and 4 males + 4 females were found dead at 1500 and 2000 mg/kg bw, respectively. While, all the males and females treated at 3000 mg/kg bw were found dead. The surviving animals recovered within 8 to 9 days. Sedation, dyspnoea, exophthalmos, ruffled fur, diarrhoea, curved body position and tremors were clinical signs observed at the tested dose levels. Body weights were not affected by the administration of test substance at any of the doses. No substance related gross organ changes were seen. Hence, based on the findings of the study, the acute oral LD50 of FAT 31016/F in rats of both sexes observed over a period of 14 days was 1635 (1377-1898) mg/kg bw.