Reaction mass of 5-[{4-[Benzyl(methyl)amino]phenyl}diazenyl]-1,4-dimethyl-4H-1,2,4-triazol-1-ium bromide and 3-[{4-[Benzyl(methyl)amino]phenyl}diazenyl]-1,4-dimethyl-4H-1,2,4-triazol-1-ium bromide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Experiment start date - 27 August 1980; Experiment end date - 22 September 1980; Study completion date - 02 October 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:

no

GLP compliance:

no

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

3(or5)-[[4-[benzylmethylamino]phenyl]azo]-1,2(or1,4)-dimethyl-1H-1,2,4-triazolium bromide

EC Number:

289-660-0

EC Name:

3(or5)-[[4-[benzylmethylamino]phenyl]azo]-1,2(or1,4)-dimethyl-1H-1,2,4-triazolium bromide

Cas Number:

89959-98-8

Molecular formula:

C18H21N6.Br

IUPAC Name:

Reaction mass of 3-[{4-[Benzyl(methyl)amino]phenyl}diazenyl]-1,4-dimethyl-4H-1,2,4-triazol-1-ium bromide and 5-[{4-[Benzyl(methyl)amino]phenyl}diazenyl]-1,4-dimethyl-4H-1,2,4-triazol-1-ium bromide

Test material form:

solid

Specific details on test material used for the study:

Name: FAT 31016/C
Purity: 85 %

Test animals

Species:

rat

Strain:

other: Tif: RAif (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Inhouse breeding
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 - 8 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod: 10 hours light.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

400

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

Doses:

300, 1000, 3000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Clinical signs including body weight: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology.

Statistics:

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

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 129 mg/kg bw

Based on:

test mat.

95% CL:

> 535 - <= 2 055

Mortality:

At 300 mg/kg: 0/5 males and females each died.
At 1000 mg/kg: 1/5 males were found dead, 5/5 females were found dead.
At 3000 mg/kg: 4/5 males and females each were found dead.

Clinical signs:

other: Sedation, dyspnoea, exopthalamos, ruffled fur, hunched posture was observed in all animals.

Gross pathology:

No substance related gross organ change was noted.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The LD50 was calculated to be 1129 mg/kg bw.

Executive summary:

An acute oral toxicity study was conducted according to guideline equivalent or similar to OECD TG 401 to evaluate toxicity of FAT 31016/C. The test substance was suspended with polyethylene glycol (PEG 400). Doses of 300, 1000 and 3000 mg/kg bw were administered to rats divided in four groups each containing 5 males and 5 females. The treated animals were observed for 14 days for clinical signs and mortality.

Mortality: At 300 mg/kg: 0/5 males and females each died.

At 1000 mg/kg: 1/5 males were found dead, 5/5 females were found dead.

At 3000 mg/kg: 4/5 males and females each were found dead.

Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased. No substance related gross organ changes were seen at post mortem examinations. Based on the findings of the study, the acute oral LD50 of FAT 31016/C in rats of both sexes observed over a period of 14 days was found to be 1129 mg/kg bw.