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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
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

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
Type of study:
patch test
Justification for non-LLNA method:
The study was performed with human volunteers (HRIPT). The study is relevant to the end use of the material.

Test material

In vivo test system

Test animals

Species:
human
Strain:
other: Human
Sex:
male/female
Details on test animals and environmental conditions:
Panel Information - Demographic
Sex Number Age Range
Female 87 18-81
Male 33 18-63

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
undiluted test substance
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
undiluted test substance
No. of animals per dose:
119 people at the initial of the study
Positive control substance(s):
no

Results and discussion

Positive control results:
Not available.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
119
Clinical observations:
No clinically significant adverse effects were detected on any of the subjects during the induction phase.
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100% . No with. + reactions: 0.0. Total no. in groups: 119.0. Clinical observations: No clinically significant adverse effects were detected on any of the subjects during the induction phase. .
Reading:
2nd reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
114
Clinical observations:
No clinically significant adverse effects were detected on any of the subjects during the challenge phase.
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 114.0. Clinical observations: No clinically significant adverse effects were detected on any of the subjects during the challenge phase. .

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The test substance was found to be devoid of clinically significant skin irritating and skin-sensitizing 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