Registration Dossier

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
Reliability:
1 (reliable without restriction)
Justification for type of information:
May, 2017. Because of in the NDA 01-04-1385-00 carried out by Germany was not requested to indicate the endpoint study record, considering the data inserted in the course of the assessment to be correct and exhaustive the proper “Adequacy of study” has been selected.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
2001

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 92/69/EWG, B.4
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
438-670-5
EC Name:
-
Cas Number:
87199-17-5
Molecular formula:
Hill formula: C7H7BO3 CAS formula: C7H7BO3
IUPAC Name:
(4-formylphenyl)boronic acid
Test material form:
solid

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Vehicle:
other: 0,9 %ige Kochsalzlösung "ENGLISH" 0,9% aqueous saline solution (NaCl)
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:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Max. score:
0
Remarks on result:
other: Max. duration: 0 d; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
erythema score
Max. score:
0
Remarks on result:
other: Max. duration: 0 d; Max. value at end of observation period: 0 (related to all animals)

Applicant's summary and conclusion

Interpretation of results:
other: not classified