N-(2-nitrophenyl)phosphoric triamide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2004-08-24 - 2004-10-27

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The GLP study was conducted according to an internationally accepted guideline. All study parameters are based on the specific guideline.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

477-690-9

EC Name:

-

Cas Number:

874819-71-3

Molecular formula:

Hill formula: C6H9N4O3P CAS formula: C6H9N4O3P

IUPAC Name:

N-(diaminophosphoryl)-2-nitroaniline

Test material form:

solid: crystalline

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

Approximately 24 hours before administration the fur was removed by shaving from the dorsal area (6x6 cm) of the trunk. Only animals with healthy intact skin were used. 0.2 g / 100 g body weight

Individual doses were adjusted according to the recorded body weight.

The test item was moistened with deionised water, applied to the shaved skin area and covered with a layer of a gaze patch and then with aluminium foil (6.5 x 6.5 cm). This patch was held in contact with the skin by occlusive dressing (Elastoplast, Beiersdorf AG), single administration on September 07, 2004, 9.25 - 9.59 a.m. After 24 hours the patch was removed and the application area was cleaned with water without altering the integrity of the epidermis.

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 male and 5 female animals

Control animals:

not required

Details on study design:

Observations

The animals were observed over a period of 14 days after administration of the test item.

Mortality

Animals were observed for mortality and morbidity continuously on the day of administration and once daily thereafter (in the morning).

Clinical Observations

The animals were monitored for general clinical condition continuously on the day of administration and once daily thereafter (in the morning).

The following signs were given predominant consideration: changes in skin, fur, eyes and mucous membranes; gait and posture; respiratory, circulatory, autonomic and central nervous system; occurrence of secretions and excretions; presence of clonic or tonic movements and stereotypies or bizarre behaviour.

Skin of the Administration Area

Animals were observed for erythema and/or oedema at the skin of the administration area one hour after patch removal and once daily thereafter (in the morning).

Body Weight Gain

Body weights were recorded on the day of administration and on days 7 and 14 thereafter.

Pathology

At the end of the observation period all animals were killed by CO2 inhalation.

All animals were examined externally. The cranial, thoracic and abdominal cavities were then opened and examined macroscopically.

Statistics:

Body weights and body weight gain:

Calculation of group mean values and standard deviations.

Comparison with historical control data.

Results and discussion

Preliminary study:

None of the animals died after a single dermal administration of 2000 mg/kg b.w. AL(2-NitrophenyI)phosphoric triamide.
Clinical signs were not observed during the observation period.
Except for a slightly yellowish discolouring not any alteration of the skin at the administration area was observed.
The body weight gain of the animals was not affected by the test item. No pathological findings were observed at necropsy.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

other: None of the animals showed alterations of the general state of well-being during the course of investigation.

Gross pathology:

There were no macroscopic pathological findings in the animals.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The dermal LD50 of N-(2-Nitrophenyl)phosphoric triamide in the rat is > 2000 mg/kg b.w.

Executive summary:

Acute dermal toxicity of N-(2 -Nitrophenylphosphoric triamide was tested in 5 male and 5 female Charles River Wistar rats according to OECD guideline 402. The test item was applied at a single dose of 2000 mg/kg body weight to a shaved dorsal area of the trunk of the animals and was then covered with a gauze patch which was held in contact with the skin with an occlusive dressing. Exposure was for 24 hours. Animals were examined for mortality, clinical signs, alterations of the administration area, body weight gain and pathological alterations of organs at the end of a 14-day observation period, None of the animals died during the course of the investigation. The LD50 dermal rat is > 2000 mg/kg b.w. Clinical signs were not observed during the observation period. Except for a slightly yellowish discolouring not any alteration of the skin at the administration area was observed. The body weight gain of the animals was not affected by the test item. No pathological findings were observed at necropsy.