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Toxicological information

Acute Toxicity: dermal

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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

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:
Animals appeared active and healthy throughout the test.
Body weight:
Animals gained weight
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