Ammonium dihydrogenorthophosphate

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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Purity test substance unknown.

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

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Monoammonium phosphate (MAP)

IUPAC Name:

Monoammonium phosphate (MAP)

Test material form:

other: Crystalline powder

Details on test material:

- Name of test material (as cited in study report): Monoammonium phosphate (MAP)
- 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

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 210-233 grams and females 180-190 grams at experimental start
- 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
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

Administration / exposure

Type of coverage:

occlusive

Vehicle:

other: moistened

Details on dermal exposure:

Prior to application, the test substance was ground in a coffee mill and moistened to achieve a dry paste by preparing an 85% w/w mixture.
In order to insure adequate contact with the skin, the sample was applied as a dry paste, and administered as an 85% w/w mixture
in distilled water.

MAP was applied to the shaved intact skin on the back of each rat and covered with gauze pads.
After 24 hours the pads were removed and the test areas gently wiped with water.

Duration of exposure:

24 hours

Doses:

5000 mg/kg of bodyweight
(85% w/w mixture) Five thousand milligrams per kilogram of bodyweight of the test substance was moistened with distilled water and applied to the skin of ten healthy rats for 24 hours. Individual doses were calculated based on the initial bodyweights, taking into account the concentration
of the test mixture.

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

Prior to application, the test substance was ground in a coffee mill and moistened to achieve a dry paste by preparing an 85% w/w mixture. In order to insure adequate
contact with the skin, the sample was applied as a dry paste, and administered as an 85% w/w mixture
in distulled water.
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: initial and again on days 7 and 14
- Necropsy of survivors performed: YES
- Other examinations performed: Individual bodyweights of the animals were recorded prior to test substance application (initial) and again on Days 7 and 14 (termination). The animals were observed for mortality, signs of gross toxicity, and behavioral changes at 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.

Statistics:

No data

Results and discussion

Preliminary study:

no data

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

All animals survived

Clinical signs:

other: Animals appeared active and healthy throughout the test.

Gross pathology:

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

Other findings:

No data

Any other information on results incl. tables

none

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Not classified according to Regulation (EC) No. 1272/2008

Conclusions:

No signs of toxicity were observed. LD50 > 5000 mg/kg