Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Remarks:
other: Human volunteer patch test
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Between 04/09/2007 and 05/14/2007.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to guideline and to GCP and adequately reported.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
To determine the test substance’s skin irritating and sensitizing potential, a Human Repeat Patch Test was conducted on 119 volunteers, following the prodedure described in Protocol-ISM 059.NOV. The regimen called for four 24-h applications of the sample conducted seriatim during each of Weeks Nos. 1, 2, 3 and 7 on assigned skin sites on the right upper arm of each subjects. Clinical adverse effects were recorded. The test regimen was conducted under double blind conditions.
GLP compliance:
yes

Test material

Test animals

Species:
other: Human
Details on test animals or test system and environmental conditions:
Panel Information - Demographic
Sex Number Age Range
Female 87 18-81
Male 33 18-63


Site Information
Site O6 Site N6 Site M6 SiteL 6
challenge application 2nd alternative site for initial phase 1st alternative site for initial phase 1st site to be exposed

Test system

Type of coverage:
occlusive
Preparation of test site:
other: The skin around the site in current use was freshly marked at each visit. The marks made it possible for the technicians to locate the site for grading in the absence of the device or other distinguishing features
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
The webril pa of a pathing device was infused with 150 ul of the test material
Duration of treatment / exposure:
24 h/exposure
Number of animals:
119
Details on study design:
Application
Initial / Induction Phase:
Week 1: Monday, Tuesday, Wednesday, Thursday
Week 2: Monday, Tuesday, Wednesday, Thursday
Week 3: Monday, Tuesday, Wednesday, Thursday
Week 4: Hiatus, make up

Challenge/Diagnostic Phase:
Week 5: Monday, Tuesday, Wednesday, Thursday

Examination
Initial / Induction Phase:
Week 1: Monday (baseline), Tuesday, Wednesday, Thursday, Friday
Week 2: Monday, Tuesday, Wednesday, Thursday, Friday
Week 3: Monday, Tuesday, Wednesday, Thursday, Friday
Week 4: Hiatus, make up

Challenge/Diagnostic Phase:
Week 5: Monday, Tuesday, Wednesday, Thursday, Friday
Week 6: Monday as needed.

For detailed regimen, see attachement.

Results and discussion

In vivo

Results
Irritation parameter:
other: clinical observations
Basis:
other: cohort study
Time point:
other: week 5
Score:
ca. 0
Reversibility:
other: No adverse effect observed
Other effects:
None.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
The test substance was found to be devoid of clinically significant skin-irritating properties that can be detected under the conditions of this patch test procedures.
Executive summary:

The test substance was submitted for a patch test to determine the sample's irritating and sensitizing potentials. A procedure based on that described in Protocol-ISM 059.Nov was followed, and 119 qualified volunteers was jointed the test initially.

The regime called for four 24-h application of the sample conducted seriatim during each of weeks Nos 1, 2, 3, and 7 on assigned skin sites o the right upper arm of each subject.

Examinations of the contacted skin and grading of its condition were conducted within moments after devices containing the sample were removed.

Weeks 1, 2, 3, and 4 formed the Initial or Induction phase of the regimen. Data were acquired on 119 subjects during this phase. No clinically significant adverse effects were detected on any of the subjects during this phase.

The challenge or diagnostic phase of the regimen was conducted during week 5. Data were acquired on 114 subjects during this phase. No clinically significant adverse effects were detected on any of the subjects during this phase.

Therefore, the test substance was found to be devoid of clinically significant skin-irritating properties that can be detected under the conditions of this patch test procedures.