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Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October 19 - November 2, 2000
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
The study was performed with a substance analogue and the data are read across.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Principles of method if other than guideline:
limit dose of 5,000 mg/kg tested
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Potassium nitrate
EC Number:
231-818-8
EC Name:
Potassium nitrate
Cas Number:
7757-79-1
Molecular formula:
HNO3.K
IUPAC Name:
potassium nitrate
Test material form:
solid: granular
Details on test material:
- Physical appearance: white granules
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Received from Ace Animals, Inc., Boyertown, PA on October 10, 2000
- Age at study initiation: Young adult (8-9 weeks)
- Weight at study initiation: males 218-246 grams and females 194-215 grams at experimental start
- Fasting period before study:
- Housing: The animals were singly housed in suspended stainless steel caging with mesh
floors which conform to the size recommendations in the most recent Guide for the
Care and Use of Laboratory Animals DHEW (NIH). Litter paper was placed beneath
the cage and was changed at least three times per week.
- Diet (e.g. ad libitum): Purina Rodent Chow #5012
- Water (e.g. ad libitum): Filtered tap water was supplied ad libitum by an automatic water dispensing
system.
- Acclimation period: 9 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-21C
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: moistened with water
Details on dermal exposure:
TEST SITE
- Area of exposure: dose area of approximately 2 inches x 3 inches
- % coverage: approximately 10% of the body surface

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): (conc. 85%)Five thousand mg/kg of bodyweight of the
test substance (6.25 g/kg of test mixture)
- Constant volume or concentration used: yes
- For solids, paste formed: yes
Duration of exposure:
24 hours


Doses:
(conc. 85%) Five thousand mg/kg of bodyweight of the test substance (6.25 g/kg of test mixture)
No. of animals per sex per dose:
5 males and 5 females
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days (or other?) 14 days
- Frequency of observations and weighing:
- Necropsy of survivors performed: yes/no Yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:
The animals were observed for mortality, signs of gross toxicity, and behavioral changes at 1 and 5
hours after application and at least once daily thereafter for 14 days. Observations included gross
evaluation of skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central
nervous systems, somatomotor activity and behavior pattern. Particular attention was directed to
observation of tremors, convulsions, salivation, diarrhea and coma.

Gross necropsies were performed on all animals. Tissues and organs of the thoracic and abdominal cavities were examined.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
all animals survived
Clinical signs:
all animals appeared active and healthy
Body weight:
all animals gained weight
Gross pathology:
Gross pathology: All animals survived, gained weight and appeared active and healthy. There were no signs of gross toxicity, adverse pharmacologic effects or abnormal behavior. No gross abnormalities were noted for the animals necropsied at the conclusion of the 14-day observation period.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Not classified according to Regulation (EC) 1272/2008
Conclusions:
LD50 > 5,000 mg/kg