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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
09 April 2013 to 19 April 2013
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Remarks:
(only moistened for good contact)
Controls:
no
Amount / concentration applied:
0,5 g
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours after removal of the pad
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
, #2
Time point:
other: 24 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: one day
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
, #2, #3
Time point:
other: 48 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
, #2, #3
Time point:
other: 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
, #2, #3
Time point:
other: 24 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
, #2, #3
Time point:
other: 48 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
, #2, #3
Time point:
other: 72 hours
Score:
0
Max. score:
4
Other effects:
A pink coloration of the treatment site, not preventing erythema assessment, was noted in all animals between days 0 and 3. A very slight erythema was noted on the treated area in all animals 1 hour after the patch removal and was totally reversible between days 1 and 2.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item has not to be classified. No signal word or hazard statement is required.