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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:
2004
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:
2004
Report date:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Internal Human repeat insult patch test (HRIPT) Protocol No. 1.01 (at CPTC)
Deviations:
not specified
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 10% test substance concentrations (in distilled water; pH 6.49) to 48 healthy volunteers for 1 to 4 d 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 followed by reading the sites for immediate and delayed responses after 24 and 72 h.
GLP compliance:
not specified
Type of study:
patch test
Justification for non-LLNA method:
- Human study

Test material

Constituent 1
Chemical structure
Reference substance name:
Alcohols, C18-unsatd and ethoxylated C18-unsatd., phosphates (5 moles ethoxylation)
Molecular formula:
C18H37O4P (representative of phosphate monoesters; i.e., mono- C18-unsatd. PSE) C28H57O9P1 (representative of ethoxylated phosphate monoesters; i.e., mono- C18-unsatd. AE5 PSE) C36H71O4P1 (representative of phosphate diesters; i.e., di- C18-unsatd. PSE) C46H91O8P1 (representative ethoxylated phosphate diesters; di- C18-unsatd. PSE and C18-unsatd. AE5 PSE) C82H161O21P1 (representative ethoxylated phosphate diesters; di- C18-unsatd. AE5 PSE)
IUPAC Name:
Alcohols, C18-unsatd and ethoxylated C18-unsatd., phosphates (5 moles ethoxylation)
Test material form:
liquid

In vivo test system

Test animals

Species:
other: Human
Sex:
male/female
Details on test animals and environmental conditions:
48 healthy volunteers

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, semiocclusive
Vehicle:
water
Concentration / amount:
10%
Day(s)/duration:
1 - 4 d
Adequacy of induction:
not specified
Challenge
Route:
epicutaneous, semiocclusive
Vehicle:
water
Concentration / amount:
10%
Day(s)/duration:
1
Adequacy of challenge:
other: two weeks after last induction
No. of animals per dose:
48
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:
10% in water
No. with + reactions:
0
Total no. in group:
48
Clinical observations:
none
Remarks on result:
other: see 'Any other information on results incl. tables'
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
10% in water
No. with + reactions:
1
Total no. in group:
48
Clinical observations:
none
Remarks on result:
other: see 'Any other information on results incl. tables'
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
not tested
Clinical observations:
not tested
Remarks on result:
not measured/tested
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
not tested
Clinical observations:
not tested
Remarks on result:
not measured/tested

Any other information on results incl. tables

Results: details

- Subject #12 developed moderate erythema and mild edema during Days 1 and 2 of induction. Patching was continued on Day 3. Subject #12 had a barely perceptible response. While on Day 4 it was noted that Subject #12 had mild erythema covering the patch site. Two weeks later subject #12 was challenged with the the test substance and there was no response indicating that the initial response was not clinically relevant.

 - Subject # 13 developed spotty erythema on Days 2, 3, and 7. Two weeks later subject #13 was challenged and 24 h later they developed moderate erythema and mild edema. By 72 h post-challenge only spotty erythema was noted (Subject # 13). This pattern of skin reactivity is suggestive of a pre-existing hypersensitivity. No evidence of induced allergic contact sensitization was recorded.

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 determined to be non-sensitiser to the skin (Croda, 2004). % in distilled/deionised water pH 6.49)
Executive summary:

A study was conducted to determine the skin sensitivity potential of the test substance, ‘mono- and di- C18-unsatd. PSE and C18-unsatd. AE5 PSE’, according to the Human Repeated Insult Patch Test (HRIPT). In the induction phase, a 10% test substance preparation (in distilled water; pH 6.49) was applied epicutaneously to 48 healthy volunteers for 1 to 4 d 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 occluded patch was removed and the site was read for immediate response. Follow-up readings were made 72 h after challenge. Subject #12 developed moderate erythema and mild edema during Day 1 and 2 of induction, barely perceptible response on Day 3 and mild erythema on Day 4. However, two weeks later the subject #12 was challenged with the test substance and there was no response indicating that the initial response was not clinically relevant. Subject # 13 developed spotty erythema on Days 2, 3, and 7. Two weeks later subject #13 was challenged and 24 h later they developed moderate erythema and mild edema. By 72 h post-challenge only spotty erythema was noted (Subject # 13). This pattern of skin reactivity is suggestive of a pre-existing hypersensitivity. No evidence of induced allergic contact sensitisation was recorded in any other volunteers. Under the study conditions, the test substance did not indicate a potential for dermal irritation or allergic contact sensitization in human volunteers at 10% test concentrations (Croda, 2004).