N-(2-nitrophenyl)phosphoric triamide

Endpoint summary

Description of key information

Skin irritation:

A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method used followed the recommendations of the OECD Guidelines for Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion". N-(2-Nitrophenyl)phosphoric triamide was found to be not irritant to the rabbit skin.

Eye irritation:

A study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method used followed that described in the OECD Guidelines for Testing of Chemicals No. 405 "Acute Eye Irritation/Corrosion". N-(2-Nitrophenyl)phosphoric triamidewas found to be not irritating to the rabbits eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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.

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

OECD 404 (2002)

GLP compliance:

yes (incl. QA statement)

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.

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

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

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.

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye 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.

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

OECD 405 (2002)

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Species/strain: Rabbits, breed: White New Zealanders (SPF Crl:NZW)
Sex: male
Supplier: Charles River Wiga GmbH, D-97320 Sulzfeld

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.1 ml

Duration of treatment / exposure:

1 h

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

3

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Remarks:

chemosis

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Remarks on result:

no indication of irritation

Other effects:

Only a slight redness of the conjunctivae in all animals one hour after instillation. One day after instillation signs of irritations were not more observed.

Alteration	Ani­	Observed grades of ocular lesions at each observation time
	mal	Hours after instillation
	No.	1		24		48		72
		Control	Test item	Control	Test item	Control	Test item	Control	Test item
Cornea	1	0	0	0	0	0	0	0	0
	2	0	0	0	0	0	0	0	0
	3	0	0	0	0	0	0	0	0
Iris	1	0	0	0	0	0	0	0	0
	2	0	0	0	0	0	0	0	0
	3	0	0	0	0	0	0	0	0
Conjunctivae	1	0	1	0	0	0	0	0	0
Redness	2	0	1	0	0	0	0	0	0
	3	0	1	0	0	0	0	0	0
Conjunctivae	1	0	0	0	0	0	0	0	0
Chemosis	2	0	0	0	0	0	0	0	0
	3	0	0	0	0	0	0	0	0

Interpretation of results:

not irritating

Remarks:

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

Conclusions:

N-(2-Nitrophenyl)phosphoric triamide is non-irritant to the eye.

Executive summary:

The acutc eye irritation/corrosion of N-(2-NitrophenyI)phosphoric triamide was tested in three albino rabbits according to OECD guideline 405. The test item was instilled as the original substance after crushing with a pestle and mortar to a fine dust at a single dose of 0.1 ml to one of the eyes in each animal. The untreated eye was used as control.

The animals were examined for clinical signs and the eyes were examined for lesions of the conjunctivae, cornea and iris 60 minutes, 24, 48 and 72 hours after instillation of the test item. The grades for ocular lesions were recorded in accordance with the OECD guideline.

The instillation of the test item caused only a slight redness of the conjunctivae in all animals one hour after instillation.

The cornea and the iris were not affected.

One day after instillation signs of irritations were not more observed. None of the animals died or showed clinical signs during the course of testing.

The alterations of the eyes after instillation of N-(2-Nitrophenyl)phosphoric triamidedo not meet the criteria for classification of a substance as an eye irritant.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

No data gaps were identified. The available data are adequate for risk assessment and classification and labelling purposes.

Justification for selection of skin irritation / corrosion endpoint:

Only one study is available. The key study is GLP-compliant and has Klimisch 1.

Justification for selection of eye irritation endpoint:

Only one study is available. The key study is GLP-compliant and has Klimisch 1.

Justification for classification or non-classification

N-(2-Nitrophenyl)phosphoric triamide is not classified as skin or eye irritant substance.