N-(2-nitrophenyl)phosphoric triamide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2004-09-09 - 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 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

OECD 404 (2002)

GLP compliance:

yes (incl. QA statement)

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:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Species/strain: White New Zealanders (SPF CrLNZW)
Sex: male
Supplier: Charles River Wiga GmbH,
D-97320 Sulzfeld
Acclimatisation: The animals were housed approximately 6 weeks before administration at the housing conditions of the test facility. In this time no signs were observed which indicated illness or other injury.

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

other: deionised water

Controls:

not required

Amount / concentration applied:

500 mg

Duration of treatment / exposure:

4 h

Observation period:

48 h

Number of animals:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Other effects:

Slightly yellowish discolouring of the skin at the
administration area on the day of administration.

Any other information on results incl. tables

Evaluation of alterations of the skin areas after administration of the test item

Ani­	Expo­	Observed grades of skin alterations at each observation time
mal	sure	Erythema hours after administration				Oedema hours after administration
No.	period	1	24	48	72	1	24	48	72
1	3 min	0 *	0	0	0	0	0	0	0
	1 h	0 *	0	0	0	0	0	0	0
	4 h	0 *	0	0	0	0	0	0	0
	Control	0	0	0	0	0	0	0	0
2	4 h	0 *	0	0	0	0	0	0	0
	Control	0	0	0	0	0	0	0	0
3	4 h	0 *	0	0	0	0	0	0	0
	Control	0	0	0	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information not classified Criteria used for interpretation of results: EU

Conclusions:

The administration of 0.5 g of N-(2-Nitrophenyl)phosphoric triamide to shaved dorsal area of the trunk of albino rabbits did not cause any irritations of the skin. No systemic toxic effects were observed.

Executive summary:

The acute dermal irritation/corrosion of N-(2-Nitrophenyl)phosphoric triamide was tested in three albino rabbits according to OECD guideline 404. The test item was applied as the original substance at a dose of 0.5g to a shaved dorsal area of trunk and covered with a gauze patch and aluminium foil which was held in contact with the skin with an occlusive dressing. The test was started with one rabbit with exposure periods of three minutes, one hour and four hours. Because no serious skin reaction was observed in this animal the result was confirmed using two further animals with a four-hour exposure.

After each exposure the administration area was cleaned with deionised water.

Animals were examined for mortality, clinical signs and signs of irritation response 60 minutes, 24, 48, 72 hours after patch removal. The grading of skin reaction given in the OECD guideline was used for the evaluation of the dermal irritation.

Not any irritation of the skin at the administration areas was observed. None of the animals died or showed clinical signs during the course of testing.

The administration of 0.5 g of N-(2-Nitrophenyl)phosphoric triamide to shaved dorsal area of the trunk of albino rabbits did not cause any irritations of the skin. No systemic toxic effects were observed.