2,1,3-Benzoxadiazole, 4,6-dinitro-, 1-oxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18 June 1992 to 16 July 1992

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: some deviations to GLP and testing guideline, but adequate coherence between data, c omments and conclusions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

total of 2 doses although lethal at 2000 mg/kg (no DL50 calculated); but this guideline has been deleted

GLP compliance:

yes

Remarks:

no laboratory GLP certificate, no analytical certificate

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

4,6-dinitro-2,1λ⁵,3-benzoxadiazol-1-one

EC Number:

700-179-1

Cas Number:

5128-28-9

Molecular formula:

C6H2N4O6

IUPAC Name:

4,6-dinitro-2,1λ⁵,3-benzoxadiazol-1-one

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: breeder
- Age at study initiation: 6 weeks
- Mean weight at study initiation: 185 g for males and 157 g for females
- Fasting period before study: 18 hours
- Housing: collective
- Diet: conventional laboratory diet, ad libitum
- Water : filtered water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 50 +/- 20%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 h / 12 h
IN-LIFE DATES: From: 18 June 1992 To: 16 July 1992

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

DMSO

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20% (dose-level of 2000 mg/kg) and 2% (dose-level of 200 mg/kg)
- Justification for choice of vehicle: no justification, the 20% solution in DMSO was provided by the
Sponsor
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: no toxic data were available, consequently the
starting dose was 2000 mg/kg

Doses:

200 and 2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Details on study design
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at least once daily for clinical signs and on days 1, 5, 8
and 15 for weighing
- Necropsy of survivors performed: yes
- Other examinations performed: none

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 200 - < 2 000 mg/kg bw

Mortality:

At 200 mg/kg, no mortality was observed.
At 2000 mg/kg, all animals were found dead 24 hours after treatment.

Clinical signs:

other: At 200 mg/kg: hypokinesia, dyspnea, hypersalivation and sedation were observed in all animals in the minutes following the treatment and in some cases up to day 3. No clinical signs were observed bet ween day 4 and day 15. At 2000 mg/kg: dyspnea, hypersal

Gross pathology:

In the animals found dead, brownish stomach mucosis was observed, probably due to haemorrhagic lesions.

Applicant's summary and conclusion

Conclusions:

The LD50 of the substance in rats after single oral administration was comprised between 200 and
2000 mg/kg.