Ammonium dihydrogenorthophosphate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October 11 - 30, 2000

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

the purity of MAP is 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 425 (Acute Oral Toxicity: Up-and-Down Procedure)

Deviations:

no

GLP compliance:

yes

Test type:

up-and-down 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 September 26 and October 10, 2000
- Age at study initiation: Young adult (8-10 weeks)
- Weight at study initiation: males 185-202 grams and females 198-206 grams
- Fasting period before study: fasted for approximately 17.5-24 hours by removing feed from their cages. During the fasting period, the rats were examined for health and weighed (initial). Six healthy rats (3 male and 3 female) were selected for test.
- 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: 6 or 15 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-22
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

An initial dose of two thousand milligrams of the test substance per kilogram of bodyweight was administered to one healthy female rat by oral
gavage. Due to the absence of mortality in this animal a second female received the same dose level. Following the completion of dosing and 100%
survival in a total of three females, a group of three males was tested (simultaneously) at the above dose level.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

All animals were observed for mortality, signs of gross toxicity, and behavioral changes at least once daily for 14 days after dosing.
Bodyweights were recorded prior to administration and again on Days 7 and 14 (termination) after dosing.
Necropsies were performed on all animals at terminal sacrifice.

Statistics:

No data

Results and discussion

Preliminary study:

no data

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

All animals survived

Clinical signs:

other: Animals appeared active and healthy throughout the study period.

Gross pathology:

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

Other findings:

none

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:

LD50 > 2000 mg/kg bw.
No signs of toxicity were observed