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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin 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 404 (Acute Dermal 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

Species:
rabbit
Strain:
New Zealand White
Remarks:
HsdIf_NZW

Test system

Type of coverage:
semiocclusive
Vehicle:
other: carboxymethylcellulose 1%
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Other effects:
No observed effects.

Applicant's summary and conclusion

Interpretation of results:
other: no classification required
Conclusions:
Considering the reported data of this irritation study it can be stated that the test item BIBR 1048 Manamide showed neither irritant nor corrosive effects.
The test item BIBR 1048 Manamide does not have to be classified and has no obligatory labelling requirement for skin irritation.