Sulphuric diamide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sulphuric diamide

EC Number:

232-262-9

EC Name:

Sulphuric diamide

Cas Number:

7803-58-9

Molecular formula:

H4N2O2S

IUPAC Name:

Sulphuric diamide

Test material form:

solid: crystalline

Specific details on test material used for the study:

Supplier: Changzou Foreign Trade Corp.Batch No.: 0073A15 (A01141026)Physical state: solid, crystalline substanceColour: whiteOdour: pungentStorage in a dry place, protected from light

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Species and strain: Crl:(WI)Br ratsSource: TOXI COOP ZRT., Budapest, HungaryHygienic level during the study: good conventionalSex: Female, nulliparous and non pregnant animalsAge of animals: Young adult rat, 8 weeks old in first and second stepBody weight range at starting (first step): 173 - 177 gBody weight range at starting (second step): 171 - 179 gAcclimatization time: 5 days in first step and 6 days in second stepAnimal health: Only healthy animals were used for the study. Health status was certified by the study director.Housing: Group caging (3 animals/cage)Cage type: Type II polypropylene/polycarbonateBedding: Laboratory bedding.Light: Artificial light, from 6 a.m. to 6 p.m.Temperature: 22 ± 3 °CRelative humidity: 30 - 70 %Ventilation: 10-15 air exchanges/hour by central air-condition system.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Doses:

An acute toxic class method was carried out involving a stepwise procedure with the use of 2000 mg/kg bw as the starting dose.

No. of animals per sex per dose:

3 animals/group

Control animals:

no

Details on study design:

A single oral administration - followed by a fourteen-day observation period - was performed by gavage. The day before treatment the animals were fasted. The food but not water was withheld overnight. Animals were weighed before the application and the food was given back 3 hours after the treatment.Animals were observed individually after dosing at least once during the first 30 minutes, then 1 h, 2 h, 3 h, 4 h, 5 h and 6 h after the treatment and twice each day for 14 days thereafter. The body weights were recorded on day 0 (just before the treatment), on day 7 and on day 15 with a precision of 1 g.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No death occurred at 2000 mg/kg bw single oral dose of SULFAMIDE (CAS 7803-58-9). All female rats in step 1 and step 2 survived until the end of the 14-day observation period.

Clinical signs:

other: No treatment related symptoms were observed throughout the 14-day post-treatment period at any groups of the female animals.

Gross pathology:

All animals survived until the scheduled necropsy on Day 15. No pathological changes were found related to the effect of the test item during the macroscopic examination of animals.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item sulfamide (CAS 7803-58-9) was not ranked into classes of Globally Harmonized Classification System (GHS).