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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October 2004
Reliability:
1 (reliable without restriction)

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)
Deviations:
not specified
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethyl 3-((1-(4-methylamino-3-nitrophenyl)methanoyl)pyridin-2-yl-amino)propionate
EC Number:
454-450-1
EC Name:
Ethyl 3-((1-(4-methylamino-3-nitrophenyl)methanoyl)pyridin-2-yl-amino)propionate
Cas Number:
429659-01-8
Molecular formula:
C18 H20 N4 O5
IUPAC Name:
ethyl 3-{1-[4-(methylamino)-3-nitrophenyl]-N-(pyridin-2-yl)formamido}propanoate
Test material form:
solid: particulate/powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Remarks:
HsdIf:NZW

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
100 mg
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
24/48/72 h
Score:
0.33
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
24/48/72 h
Score:
0.33
Reversibility:
not fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
24/48/72 h
Score:
0.33
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 2 days

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Conclusions:
Considering the reported data of this irritation study it can be stated that the test item BIBR 1048 Manamide produced slight irritation but no corrosive effects.
The test itm BIBR 1048 Manamide does not have to be classified and has no obligatory labelling requirement for eye irritation.