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Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
From April 16, 2001 to May 24, 2001
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
A Human Repeated Insult Patch Test (HRIPT) was conducted to determine the skin sensitivity potential of the test substance, following epicutaneous induction with 5% test substance concentrations to 53 healthy volunteers for 24 h under a semi-occlusive conditions. After a rest period of ca. 2 weeks, the substance was applied under the same conditions to a new site as a challenge. A the end of 24 h, the semi-occluded patch is removed and the site is read for immediate response. Follow-up readings are made 24 and 72 h later. The skin effects are then scored for irriation (erythema, edema as well as other irritation signs).
GLP compliance:
yes
Remarks:
ICH Guideline E6 for Good Clinical Practice (GCP) and 21CFR part 50 and 56 compliant
Type of study:
patch test
Justification for non-LLNA method:
- Human study

Test material

Constituent 1
Chemical structure
Reference substance name:
Alcohols, C16-18 and ethoxylated C16-18 , phosphates (20 moles ethoxylation)
Molecular formula:
C18H39O4P1 (monoester representative, i.e., mono- C18 PSE) C56H115O24P1 (ethoxylated monoester representative, i.e., mono- C16 AE20 PSE) C32H67O4P1 (diester representative, i.e., di- C18 PSE) C112H227O44P1 (ethoxylated diester representative, i.e., di- C16 AE20 PSE)
IUPAC Name:
Alcohols, C16-18 and ethoxylated C16-18 , phosphates (20 moles ethoxylation)
Test material form:
solid

In vivo test system

Test animals

Species:
other: Human, healthy volunteers
Sex:
male/female

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, semiocclusive
Vehicle:
not specified
Concentration / amount:
0.2 mL (5% solution)
Day(s)/duration:
application of 24 hours on 3 different days for three weeks
Adequacy of induction:
not specified
Challenge
Route:
epicutaneous, semiocclusive
Vehicle:
not specified
Concentration / amount:
0.2 mL (5% solution)
Day(s)/duration:
24 hours, then follow-up readings (at 24 and 72 h)
Adequacy of challenge:
other: sensitisation responses on an adjacent virgin test site
No. of animals per dose:
53
Details on study design:
In the induction phase, 0.2 mL test substance preparation (5%) was applied epicutaneously on 53 healthy volunteers for 24 h under an semiocclusive type of coverage. The applications were done daily on Monday, Tuesday and Friday for 3 consecutive weeks. After a rest period of ca. 2 weeks, the test substance was applied with the same conditions on a new site as a challenge. A the end of 24 h, the semi-occluded patch was removed and the site was read for immediate response. Follow-up readings were made 24 and 72 h later. The skin effects were then scored for irriation (erythema, edema as well as other irritation signs).
Challenge controls:
-
Positive control substance(s):
no

Results and discussion

Positive control results:
-

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.2 mL of a 5% test solution
No. with + reactions:
0
Total no. in group:
53
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
0.2 mL of a 5% test solution
No. with + reactions:
0
Total no. in group:
53
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Group:
negative control
Remarks on result:
not measured/tested
Key result
Reading:
1st reading
Group:
positive control
Remarks on result:
not measured/tested

Applicant's summary and conclusion

Interpretation of results:
other: not classified based on EU CLP criteria
Conclusions:
Under the study conditions, the test substance was not considered as a human skin sensitizer (semi-occlusive patch test).
Executive summary:

A study was conducted to determine the skin sensitisation potential of the test substance, mono- and di- C16-18 PSE and C16-18 AE20 PSE’ using human repeated insult patch test (HRIPT), in compliance with ICH Guideline E6 for Good Clinical Practice (GCP) and 21CFR part 50 and 56. In the induction phase, a 5% test substance preparation was applied epicutaneously 3 times weekly to 53 healthy volunteers for 24 h under a semi-occlusive conditions. After a rest period of ca. 2 weeks, the substance was applied under the same conditions to a new site as a challenge. At the end of 24 h, the semi-occluded patch was removed and the site was read for immediate response. Follow-up readings were made 24 and 72 h later. The skin effects were then scored for irriation (erythema, edema as well as other irritation signs). No visible irritation was observed in any of the 53 individuals following challenge. Under the study conditions, the test substance was not considered to be sensitising to the human skin at 5% test concentration (CPT, 2001).