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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: in vivo
Type of information:
other: SNIF
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)

Data source

Referenceopen allclose all

Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
2008
Reference Type:
other: SNIF#001-4.150-01
Title:
Unnamed
Year:
2008

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Annex V.
GLP compliance:
yes

Test material

Test animals

Species:
other: Rabbit, New Zealand White

Test system

Type of coverage:
semiocclusive
Vehicle:
other: None.
Duration of treatment / exposure:
4 h
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
2.3
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
3
Irritation parameter:
erythema score
Max. score:
3
Remarks on result:
other: Max. duration: d; Max. value at end of observation period: 2 (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:
1.3
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
1.7
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
1.3
Irritation parameter:
edema score
Max. score:
2
Remarks on result:
other: Max. duration: d; Max. value at end of observation period: 1 (related to all animals)
Irritant / corrosive response data:
Reversibility of any observed effect: Changes not fully reversible within 15 days
Other effects:
After a 4-hour exposure (three animals), a yellow coloration
of the skin was observed throughout the observation period
in 2/3 animals and on day 1 only in the third animal. In 1/3
animals, the evaluation of erythema was masked by this
coloration from days 1 to 3.

A dryness of the skin was recorded in all the animals
between days 4 and 15. A brownish area was observed in 1/3
animals between days 4 and 6.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information