Potassium carbonate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: US EPA Pesticide Assessment Guidelines, Subdivision F, Hazard Evaluation: Human and Domestic Animals, November 1984, Acute Exposure, Dermal Toxicity

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Potassium carbonate

EC Number:

209-529-3

EC Name:

Potassium carbonate

Cas Number:

584-08-7

Molecular formula:

CH2O3.2K

IUPAC Name:

dipotassium carbonate

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Davidson's Mill Farm, S. Brunswick, New Jersey
- Age at study initiation: no data in study summary
- Weight at study initiation: no data in study summary
- Fasting period before study: no data in study summary
- Housing: no data in study summary
- Diet (e.g. ad libitum): no data in study summary
- Water (e.g. ad libitum): no data in study summary
- Acclimation period: no data in study summary


ENVIRONMENTAL CONDITIONS
no data in study summary

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: no data in study summary
- % coverage: no data in study summary
- Type of wrap if used: no data in study summary


REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped clean of any residual material
- Time after start of exposure: 24 hours


2000 mg/kg bw of the test substance was moistened with distilled water and applied to intact dose sites.

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The rabbits were observed on several occasions and at least once daily.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: no animal died

Mortality:

All animals survived.

Clinical signs:

other: One male exhibited a reduction in food consumption on days 11-12. Apart from the dermal irritation at the dose site of all animals, there were no other signs of gross toxicity, adverse pharmacologic effects or abnormal behavior.

Gross pathology:

Gross necropsy findings at terminal sacrifice were unremarkable. All tissues and organs appeared normal.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

On the basis of the results obtained after a single dermal administration, the oral LD50 of the test article "Biocide #5654, Potassium Carbonate"
was determined to be > 2000 mg/kg bw. All animals survivied. No significant clinical signs, effects on body weight or gross pathological findings were observed apart from dermal irritation at the dose site of all animals.

Executive summary:

In an acute dermal toxicity study performed according to the US EPA Pesticide Assessment Guidelines, Subdivision F, Hazard Evaluation: Human and Domestic Animals, November 1984, Acute Exposure, Dermal Toxicity, 5 male and 5 female young adult New Zealand With rabbits were dermally exposed to the test article "Biocide #5654, Potassium Carbonate" moistened in distilled water for 24 hours at a dose of  2000 mg/kg bw.  Animals then were observed for 14 days.

 

Dermal LD₅₀ Combined:  > 2000 mg/kg bw

 

No animal died in this limit test.       

 

No significant clinical signs or effects on body weight were observed, apart from dermal irritation at the dose site of all animals. There were no treatment related gross necropsy findings at terminal sacrifice. All tissues and organs appeared normal.