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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

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.

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 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
OECD 405 (2002)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
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
Details on test material:
Nature of substance: solid, grinded in a mortar

Test animals / tissue source

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

Test system

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

Results and discussion

In vivo

Resultsopen allclose all
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.

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.