Reaction products of sulphuric acid, rock phosphate and humic acids, potassium salts

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:

17 October 2000 - 31 October 2000

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well documented, GLP-compliant, according to OECD 402 in rat, but purity of test substance unknown. For justification of read-across see CSR chapter 1.3.

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:

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

Test material information

Constituent 1

Reference substance name:

Diammonium phosphate

IUPAC Name:

Diammonium phosphate

Constituent 2

Reference substance name:

Diammonium hydrogenorthophosphate

EC Number:

231-987-8

EC Name:

Diammonium hydrogenorthophosphate

Cas Number:

7783-28-0

Molecular formula:

H9N2O4P

IUPAC Name:

diammonium hydrogen phosphate

Details on test material:

- Name of test material (as cited in study report): Diammonium phosphate (DAP)
- Physical state: dark brown granules
- Purity test date: no data
- Stability under test conditions: considered stable (provided by sponsor)
- 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 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:

5000 mg/kg bw

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

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

All animals survived.

Clinical signs:

other: All animals appeared active and healthy throughout the test.

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:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

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

Executive summary:

Acute dermal toxicity of the test material was determined according to OECD TG 402 and GLP.

Five male and 5 female sprague-dawley rats were applied 5000 mg/kg bw (as a paste of 85% test substance in water) occlusively for 24 hours and observed for 14 days. All animals survived, appeared active and healthy throughout the study period, gained weight and did not show gross abnormalities in necropsy and histopathology. No other signs of gross toxicity, adverse pharmacologic effects or abnormal behavior were observed. Therefore, the test substance did not seem to cause signs of toxicity in rats at the tested dose. It is concluded that the acute dermal LD50 in rats is above 5000 mg/kg bw.