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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
October 11 - 30, 2000
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP-compliant and according to OECD425 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 425 (Acute Oral Toxicity: Up-and-Down Procedure)
Deviations:
no
GLP compliance:
yes
Test type:
up-and-down procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
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: (P2O5) Available Phosphoric Acid – 52.25% Total nitrogen – 11.38%
- 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): 17-22ºC
- 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
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:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 > 2000 mg/kg bw.
No signs of toxicity were observed