Reaction mass of Ammonium dihydrogenorthophosphate and diammonium hydrogenorthophosphate.

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

October 17-31, 2000

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP-compliant and according to OECD 402 in rat. 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:

Ammonium dihydrogenorthophosphate

EC Number:

231-764-5

EC Name:

Ammonium dihydrogenorthophosphate

Cas Number:

7722-76-1

Molecular formula:

H3N.H3O4P

IUPAC Name:

ammonium dihydrogen phosphate

Details on test material:

- Analytical purity: Available Phosphoric Acid – 52.25% Total Nitrogen – 11.38%
- Stability under test conditions: Test substance is expected to be stable for the duration of testing
- Storage condition of test material: July 5, 2001

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°C
- 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 distilled 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 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

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:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

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