Potassium carbamoylcarbamate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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: Study performed according to GLP/OECD guideline without 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 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes

Test type:

standard acute 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.
- Age at study initiation: Approximately 9 to 10 weeks old on Day 1.
- Weight at study initiation: Range of 185 g to 310 g.
- Housing: During the acclimatisation period, four rats of the same sex were group caged. From the day prior to dosing (Day –1), each rat was
individually housed in a similar cage. After completion of the Day 3 observations animals allocated to the main study were returned to group 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. The water had been periodically analysed for specific contaminants.
- Acclimation period:The condition of the animals was assessed daily throughout the acclimatisation period of 7 to 14 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 11 January 2012 to 01 February 2012.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Electric clippers were used to remove all hair from the dorsum on the day before dosing. The dermal test site was an area of at least 10% of the total body surface on the clipped dorsum of the rat. The total surface area (cm2) for each animal was calculated according to the largest animal in each
group using the following formula:
Surface area (cm2) = K x body weight (g)2/3 (where K = 9)
Individual dose weights (mg) were calculated from the body weights of the rats on the morning of dosing (Day 1).
The test article was spread as uniformly as possible over the dermal test site. The test article was moistened with purified water in order to maximise dermal contact. A dense gauze patch was placed over the treated skin and retained in place by an elasticated, open-weave, adhesive compression
bandage. This was wrapped securely around the torso of the animal. The dressing was removed approximately 24 hours after application. The
dermal test site of each rat was lightly brushed clean of any solid residues and swabbed with water-moistened cotton wool before the animal was
returned to the holding cage.

Duration of exposure:

24 hours

Doses:

2000mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

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.Animals were weighed on Day 1 (day before dosing) and on Days 1, 4, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: 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.

Statistics:

none

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

other: There were no apparent clinical signs of reaction to treatment.

Gross pathology:

No macroscopic changes were noted at necropsy.

Other findings:

Well defined erythema was noted at the treatment sites of three males and two females on removal of the dressings at the end of the exposure
period. No other dermal reactions were noted.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

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