Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other: body responsible for the test
Title:
Unnamed
Year:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Directive 84/449/CEE - B4
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-butyl-4-chloro-5-formylimidazole
EC Number:
410-260-0
EC Name:
2-butyl-4-chloro-5-formylimidazole
Cas Number:
83857-96-9
Molecular formula:
C8 H11 Cl N2 O
IUPAC Name:
2-butyl-4-chloro-1H-imidazole-5-carbaldehyde

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Vehicle:
other: sans, pansement humiditié (0,5 ml d'eau distillée)
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
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
fully reversible within:
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
0.7
Reversibility:
fully reversible within:
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
fully reversible within:
Irritation parameter:
erythema score
Max. score:
1
Remarks on result:
other: Max. duration: 72 d; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
fully reversible within:
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
fully reversible within:
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: overall at 24, 46 and 72 h
Score:
0
Reversibility:
fully reversible within:
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)
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 3 days

Any other information on results incl. tables

I1 faut li re 72 heures .

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU