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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:
17 October 2000 - 31 October 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Animal Room Temperature Range in study was 17-22°C compared to 22°C± 3° in OECD402. The study integrity was not adversely affected by the deviation.
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Diammonium phosphate (DAP)
- Physical state: dark brown granules
- Storage condition of test material: Room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals 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 200-227 grams and females 170-184 grams
- Fasting period before study: not applicable
- 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
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
DAP 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. The animals were observed for a post-dosing period of 14 days. Prior to application, the test substance was ground in a coffee mill and moistened to achieve a dry paste by preparing a 85% w/w mixture.
Duration of exposure:
24 hours
Doses:
No data
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
The animals were observed for a post-dosing period of 14 days.
- Frequency of observations and weighing: 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. Individual bodyweights of the animals: prior to test substance application Day 0 and on Days 7 and 14 (termination).
- Necropsy of survivors performed: yes (all animals)
- Other examinations performed: 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. Tissues and organs of the thoracic and abdominal cavities were examined at necropsy.
Statistics:
No data

Results and discussion

Preliminary study:
none
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
All animals survived.
Clinical signs:
All animals appeared active and healthy throughout the test.
Body weight:
All animals gained weight.
Gross pathology:
No gross abnormalities were noted for any of the animals.
Other findings:
No other signs of gross toxicity, adverse pharmacologic effects or abnormal behavior.

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