Potassium carbamoylcarbamate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14 days

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Following GLP/OECD gulidline with no deficiency.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

potassium allophonate

IUPAC Name:

potassium allophonate

Constituent 2

Reference substance name:

Potassium carbamoylcarbamate

EC Number:

247-728-7

EC Name:

Potassium carbamoylcarbamate

Cas Number:

26479-35-6

Molecular formula:

C2H4N2O3.K

IUPAC Name:

potassium N-carbamoylcarbamate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report):Potassium Allophonate
- Physical state:powder
- Analytical purity:83.8%
- Storage condition of test material: room temperature in the dark

Test animals

Species:

rat

Strain:

other: HsdHan:WIST

Sex:

female

Details on test animals or test system and environmental conditions:

Species, strain and supplier: Female (nulliparous, non-pregnant) HsdHan™:WIST strain rats were obtained from Harlan UK Ltd, Bicester.

Acclimatisation period and allocation to study: Rats were arbitrarily selected from the delivery boxes and allocated to the appropriate number of
cages using a sequence that reduced selective bias. The condition of the animals was assessed daily throughout the acclimatisation period of 6 to 8 days.Overtly healthy animals were arbitrarily allocated to the study groups at least one day prior to dosing. At the start of the study the rats were 8 to 9 weeks of age and weighed 170 g to 192 g on Day -1. The weight variation did not exceed ±20% of the mean weight.

Caging:The animals were housed in groups of up to five during the acclimatisation period. From the day prior to dosing (Day –1), the rats were
housed in groups of three in similar cages.

Diet, water and bedding: SQC(E) Rat and Mouse Maintenance Diet No 1, from Special Diets Services Ltd, Witham, UK was freely available to the animals at all times, except for a period of fasting from the evening of the day prior to dosing (Day -1) until approximately 3 hours after dosing. Each batch
of diet had been analysed for specific constituents and contaminants by the manufacturer.
Mains water was provided, ad libitum, via cage-mounted water bottles. The water had been periodically analysed for specific contaminants.
Certificates of analysis for contaminant levels in each batch of diet or in the water supply were consigned to central files at this laboratory.
Environment: The animal rooms were designed to permit 15 to 20 air changes per hour. The temperature and humidity ranges were 20 to 24 degrees C and 45% to 65% humidity, respectively. Daily recordings of maximum and minimum temperature and humidity were made. The rooms were
illuminated by fluorescent strip-lights for twelve hours daily.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Treatment of animals was sequential. Sufficient time was allowed between each group to confirm the survival of the previously dosed animals.
Dose levels were expressed gravimetrically and in terms of test article received (without regard to purity or active content).
Individual doses (mL) were calculated using the fasted body weights of the rats on the morning of dosing (Day 1) and the dose volume of 10 mL/kg.
The test article was dispersed in purified water. The formulated concentration was calculated from the selected dose level and the dose volume of 10 mL/kg. All formulations were used within two hours of preparation.
The formulations were maintained on a magnetic stirrer to ensure homogeneity.

Doses:

2000 mg/kg

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
All animals were examined at the beginning and end of the working day throughout the acclimatisation and study periods to ensure they were in
good health.
Rats were weighed on Day 1 (day before dosing) and on Days 1, 4, 8 and 15.
- Necropsy of survivors performed: yes
- Clinical signs:Clinical signs were recorded immediately post dose, at approximately 15 and 30 minutes post dose, hourly between 1 and 4 hours
post dose (inclusive), twice daily on Days 2, 3 and 4 and once daily from the fifth to last day of the observation period. Individual records of clinical
signs were maintained for each treated rat.
- Other examinations performed: none.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Mortality Ratio 0/6

Clinical signs:

other: No clinical signs seen throughout the observation period.

Gross pathology:

No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

The acute median lethal oral dose level of the test article, Potassium Allophonate, was found to exceed 2000 mg/kg.
The test material was considered to have no significant acute toxic risk in respect of its acute oral toxicity and did not meet the criteria for
classification according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).