Ammonium carbonate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Test method in accordance with EU Method B.3 and OECD Guideline 402. GLP study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

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

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Ammonium carbonate

EC Number:

233-786-0

EC Name:

Ammonium carbonate

Cas Number:

10361-29-2

Molecular formula:

CH2O3.xH3N

IUPAC Name:

diammonium carbonate

Details on test material:

- Name of test material (as cited in study report): The substance is not classified as eye irritant.
- Physical state: Solid
- Analytical purity: 99.5%

Test animals

Species:

rat

Strain:

other: CRL:(WI)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, D-97633 Sulzfeld
- Age at study initiation: Young adult rats
- Weight at study initiation: Between 223 g and 257 g
- Fasting period before study: Overnight
- Housing: Individual caging. Type II. polypropylene/polycarbonate with lignocel bedding.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.8 – 23.4°C
- Humidity (%): 31 - 49 %
- Air changes (per hr): 15-20 air exchanges/hour
- Photoperiod (hrs dark / hrs light): 12 hours daily, from 6.00 a.m. to 6.00 p.m.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 10 % area of the total body surface
- % coverage: Sterile gauze pads, approximately 5x5 cm.
- Type of wrap if used: These gauze pads were kept in contact with adhesive hypoallergenic plaster. The entire trunk of the animal was then wrapped with semi occlusive plastic wrap.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period, the area of skin treated with the test item was washed with water of body temperature.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Constant volume or concentration used: no
- For solids, paste formed: no

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 rats per sex and per dose.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were performed on the day of treatment at 1 and 5 hours after application of the test item and once each day for 14 days thereafter. The body weights were recorded on Day 0 (before test item administration) and on Days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed:
Clinical observations: skin and fur, eyes and mucous membranes, the respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Skin irritation: Adverse skin reactions at the site of application were recorded daily following the removal of the dressing according to the Draize scale for scoring primary skin irritation.
Necropsy: After examination of the external appearance, the cranial, thoracic and abdominal cavities were opened and the appearance of the tissues and organs was observed. All macroscopic changes were recorded.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

The test item did not cause mortality at the dose level of 2000 mg/kg bw.

Clinical signs:

other: No clinical signs were observed after the treatment with the test item or during the 14-day observation period.

Gross pathology:

There was no evidence of the test item-related observations at a dose level of 2000 mg/kg bw at necropsy.

Other findings:

No dermal signs were observed after treatment with the test item during the 14 day observation period.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of the test item Ammonium carbonate was found to be greater than 2000 mg/kg body weight in male and female rats.

Executive summary:

An acute dermal toxicity study was performed with test in CRL:(WI) rats, in compliance with OECD 402. A limit test was carried out at 2000 mg/kg body weight (bw) in both sexes (5 rats/sex). The test item was applied as supplied as a single dermal 24-hour exposure followed by a 14-day observation period. Clinical observations were performed on all animals at 1 and 5 hours after dosing and daily for 14 days thereafter. Body weight was measured prior to dosing on Day 0 and on Days 7 and 14. Gross macroscopic examination performed on all animals at the end of the 2-week observation period (Day 14). No effects were observed. The acute dermal median lethal dose (LD50) of the test item Ammonium carbonate was found to be greater than 2000 mg/kg body weight in male and female rats.