Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 / corrosion
Data waiving:
other justification
Justification for data waiving:
other:

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: EEC Directive 2004/73, B.4.
GLP compliance:
yes

Test material

Constituent 1

Test animals

Species:
other: New Zealand White rabbit

Test system

Type of coverage:
semiocclusive
Vehicle:
other: No vehicle used.
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:
2.67
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
2
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
3.33
Irritation parameter:
erythema score
Max. score:
4
Remarks on result:
other: Max. duration: 72 d; Max. value at end of observation period: 4 (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:
2
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:
1.67
Irritation parameter:
edema score
Max. score:
2
Remarks on result:
other: Max. duration: 72 d; Max. value at end of observation period: 2 (related to all animals)
Irritant / corrosive response data:
Reversibility of any observed effect: Changes not fully reversible within 14 days
Other effects:
No clinical signs of systemic toxicity were observed and no
mortality occurred.

Coloration:

No staining was produced by the test item.

Corrosion:

Neither alterations nor corrosion of the treated skin were
observed.

Body weights:

The body weights of all rabbits were considered to be in the
normal range of variability.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information