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Toxicological information

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 March 10 to April 19, 1997
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:
1997
Report date:
1997

Materials and methods

Principles of method if other than guideline:
Repeat patch test for skin compatibility in 32 humans each receiving 9 × epidermal inductions and 1 × epidermal challenge
GLP compliance:
no
Remarks:
Good Clinical Practice compliant
Type of study:
other: repeat patch test for skin compatibility in humans
Justification for non-LLNA method:
Data from a human study were available.

Test material

Constituent 1
Reference substance name:
Red RA 10463
IUPAC Name:
Red RA 10463

In vivo test system

Test animals

Species:
other: human
Sex:
male/female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: Polyester lnterlock1880, treated with staining aids and stained with test item
Concentration / amount:
2 % test item
Day(s)/duration:
48 hour exposure on test days 1, 3, 5, 8, 10, 12, 15, 17 and 19
Adequacy of induction:
other: concentration used in production
Route:
epicutaneous, occlusive
Vehicle:
other: Polyester lnterlock1880, treated with staining aids
Concentration / amount:
0 % test item
Day(s)/duration:
48 hour exposure on test days 1, 3, 5, 8, 10, 12, 15, 17 and 19
Adequacy of induction:
other: concentration used in production
Route:
epicutaneous, occlusive
Vehicle:
other: Polyester lnterlock1880, untreated
Concentration / amount:
0 % test item
Day(s)/duration:
48 hour exposure on test days 1, 3, 5, 8, 10, 12, 15, 17 and 19
Adequacy of induction:
other: concentration used in production
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other:
Concentration / amount:
2 % test item
Day(s)/duration:
48 hour exposure on test day 36
Adequacy of challenge:
other: concentration used in production
No. of animals per dose:
32 volunteer humans: 27 females and 5 males
Challenge controls:
- Negative controls: (a) Polyester Interlock1880 treated with staining aids; and (b) Polyester Interlock1880 untreated
- Assessed in induction and challenge exposures in an identical manner to the test material
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
0
Group:
test chemical
Dose level:
2 %
No. with + reactions:
0
Total no. in group:
32
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Remarks:
0 % sensitisation rate
Reading:
2nd reading
Hours after challenge:
24
Group:
test chemical
Dose level:
2 %
No. with + reactions:
0
Total no. in group:
32
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Remarks:
0 % sensitisation rate
Reading:
other: 3rd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
2 %
No. with + reactions:
0
Total no. in group:
32
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Remarks:
0 % sensitisation rate
Reading:
1st reading
Hours after challenge:
0
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
32
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Remarks:
0 % sensitisation rate following exposure to both the untreated test material and to the test material treated with staining aids
Reading:
2nd reading
Hours after challenge:
24
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
32
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Remarks:
0 % sensitisation rate following exposure to both the untreated test material and to the test material treated with staining aids0 % sensitisation rate following exposure to both the untreated test material and to the test material treated with staining aids
Reading:
other: 3rd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
32
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Remarks:
0 % sensitisation rate following exposure to both the untreated test material and to the test material treated with staining aids
Group:
positive control
Remarks on result:
other: no positive control included

Applicant's summary and conclusion

Interpretation of results:
other: not classified for skin sensitisation according to the CLP Regulation (EC) No. 1272/2008
Conclusions:
Sensitisation rate: 0 %; therefore, not considered a potential skin sensitiser in humans.