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)
Rationale for reliability incl. deficiencies:
other: GLP compliance and OECD method

Data source

Reference
Reference Type:
other: ECHA inquiry result
Title:
Unnamed
Year:
2013

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 84/449EWG,b.4;OECD 404
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
other: RBT, NEW ZEELAND WHITE CHBB:nzw

Test system

Type of coverage:
occlusive
Vehicle:
other: 0.5%(W/V)CARBOXYMETHYLCELLULOSE IN 0.1%(W/V) ACQUEOUS POLYSORBATE 80
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4h
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 72h
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 24, 48 and 72h
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:24d;Max. value at end of overvation period:(related to all animals)
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 7 days
Other effects:
All effects were reversible by the end of the seven day
observation period.

Applicant's summary and conclusion

Interpretation of results:
other: not classified