Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
other: rbt, New Zealand White Chbb: NZW
Strain:
not specified

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
other: 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) acqueous polysorbate 80
Controls:
not specified
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4h
Observation period:
no data
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:
0.07
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:
erythema score
Max. score:
1
Remarks on result:
other: Max.duration: 72 d; Max. value at end of observation period: (related to all animals)
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:
1
Remarks on result:
other: Max. duration: 24 d; Max. value at end of observation period: (related to all animals)
Irritant / corrosive response data:
Reversibility of any observed effect: Charges fully reversible within 7 days.
Other effects:
All effects were reversible by the end of the 7 day observation period.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information