Potassium carbamoylcarbamate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study performed under GLP/OECD guideline without deficiency.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 436 (Acute Inhalation Toxicity: Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

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:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:Male and female (nulliparous, non-pregnant) HsdHan:WIST strain rats from Harlan UK Ltd, Bicester.
- Age at study initiation:8 to 12 weeks old.
- Weight at study initiation:193 to 222 g (males) and 214 to 219 g (females).
- Fasting period before study: none
- Housing:
- Diet (e.g. ad libitum):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.
- Water (e.g. ad libitum):Mains water was provided, ad libitum, via cage-mounted water bottles.
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):20 to 24 degrees C
- Humidity (%):45% to 65%
- Air changes (per hr):15 to 20
- Photoperiod (hrs dark / hrs light):12/12

IN-LIFE DATES: From 14 December 2011 to 28 December 2011

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose only

Vehicle:

other: purified water

Details on inhalation exposure:

VEHICLE
- Composition of vehicle (if applicable):H2O
- Concentration of test material in vehicle (if applicable):25% w/v
- Justification of choice of vehicle: During the method development it was found that the target concentration of 5 mg/L specified in the protocol could not be achieved using the test article as supplied. The test article was therefore prepared as a solution in purified water at a concentration of 25% w/v.


TEST ATMOSPHERE (if not tabulated)
- Particle size distribution:1-4μm
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.):3.46 μm

CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration: target concentration of 5 mg/L specified in the protocol could not be achieved

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

ca. 4 h

Concentrations:

2.26mg/L.

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:Treated rats were observed at hourly intervals, commencing 30 minutes after the start of exposure, until the end of the working day. An additional observation was made when the animals were returned to their home cage (approximately 10 minutes after the end of the exposure). Animals were then observed once daily to the last day of the observation period. Individual records of clinical signs were
maintained for each treated rat.
- Necropsy of survivors performed: yes
- Other examinations performed: Clinical signs and body weight.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 2.26 mg/L air

Based on:

test mat.

Mortality:

negative

Clinical signs:

other: Signs of reaction to treatment were confined to vocalisation, red coloured staining on the head, unkempt appearance and wet fur. The signs developed from 10 minute after the end of the exposure period and lasted up to 3.5 hours after the end of the expos

Body weight:

All rats gained weight during the first and second weeks of 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 concentration of potassium allophonate was found to exceed 2.26 mg/L. It was not possible to classify the test material according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS), as it was not possible to obtain a respirable particle size at a concentration of greater than 5 mg/L.