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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Data originally submitted as part of the 67/548/EEC notification package.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 92/69/EWG, B.4
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
solid crystalline powder

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Vehicle:
water
Controls:
not specified
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Number of animals:
3

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
other: erythema score
Value:
0
Remarks on result:
other:
Remarks:
Basis: animal #1 (mean score 1). Time point: overall at 24, 48 and 72 h. (migrated information)
Irritation / corrosion parameter:
other: erythema score
Value:
0
Remarks on result:
other:
Remarks:
Basis: animal #2 (mean score 2). Time point: overall at 24, 48 and 72 h. (migrated information)
Irritation / corrosion parameter:
other: erythema score
Value:
0
Remarks on result:
other:
Remarks:
Basis: animal #3 (mean score 3). Time point: overall at 24, 48 and 72 h. (migrated information)
Irritation / corrosion parameter:
other: erythema score
Remarks on result:
other:
Remarks:
Max. score: 0.0. Remarks: Max. duration: d; Max. value at end of observation period: 0 (related to all animals). (migrated information)
Irritation / corrosion parameter:
other: edema score
Value:
0
Remarks on result:
other:
Remarks:
Basis: animal #1 (mean score 1). Time point: overall at 24, 48 and 72 h. (migrated information)
Irritation / corrosion parameter:
other: edema score
Value:
0
Remarks on result:
other:
Remarks:
Basis: animal #2 (mean score 2). Time point: overall at 24, 48 and 72 h. (migrated information)
Irritation / corrosion parameter:
other: edema score
Value:
0
Remarks on result:
other:
Remarks:
Basis: animal #3 (mean score 3). Time point: overall at 24, 48 and 72 h. (migrated information)
Irritation / corrosion parameter:
other: edema score
Remarks on result:
other:
Remarks:
Max. score: 0.0. Remarks: Max. duration: d; Max. value at end of observation period: 0 (related to all animals). (migrated information)

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information not classified Criteria used for interpretation of results: EU
Conclusions:
Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites of the animals were examined for evidence of primary irritation.

No effects were noted. The substance is not classified.
Executive summary:

Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites of the animals were examined for evidence of primary irritation.

No effects were noted. The substance is not classified.