Ammonium nitrate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October 17-31, 2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

other company data

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

GLP compliance:

yes

Test type:

other: Limit test (5 males/5 females).

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Ammonium nitrate

EC Number:

229-347-8

EC Name:

Ammonium nitrate

Cas Number:

6484-52-2

Molecular formula:

H3N.HNO3

IUPAC Name:

ammonium nitrate

Test material form:

solid: granular

Details on test material:

- Physical state: white granules


- Analytical purity: Total Nitrogen – 34.70%
- Lot/batch No.:
- Expiration date of the lot/batch: July 5, 2001
- Stability under test conditions: Test substance is expected to be stable for the duration of testing
- Storage condition of test material: room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Remarks:

Albino

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 207-240 grams and females 170-188 grams at experimental start
- Fasting period before study:
- Housing: 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: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-22
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

Administration / exposure

Type of coverage:

other: The test material was applied to the shaved intact skin on the backs of each animal and covered with a gauge pad

Vehicle:

not specified

Details on dermal exposure:

TEST SITE
- Type of wrap if used: gauge pad
- Area of exposure: clipped 2 inches x 3 inches
- % coverage: approximately 10% of the body surface

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

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): (conc. 90%) Five thousand mg/kg of bodyweight of the
test substance (5.56 g/kg of the test mixture)
- Constant volume or concentration used: yes
- For solids, paste formed: yes

Duration of exposure:

24 hour

Doses:

concentration = 90% Five thousand mg/kg of bodyweight of the test substance (5.56 g/kg of the test mixture)

No. of animals per sex per dose:

5 males/5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: 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 3 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 other: mg/kg

Based on:

other: no effects

Mortality:

All animals survived.

Clinical signs:

other: no signs of toxicity were observed.

Gross pathology:

MALES: All tissues/organs No gross abnormalities
FEMALES: All tissues/organs No gross abnormalities

Any other information on results incl. tables

All animals survived, gained weight and appeared active and healthy throughout the test. No signs of toxicity were observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 >5000 mg/kg