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Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to or similar to study guidelines (OECD406 and Method B6, 92/69/EEC Directive): GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
and Method B6 (92/69/EEC Directive)
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
A mixture of isomers of branched tetracosane
EC Number:
417-060-2
EC Name:
A mixture of isomers of branched tetracosane
Cas Number:
151006-61-0
Molecular formula:
C24H50
IUPAC Name:
Hydrogenated dimerization products of 1-dodecene
Constituent 2
Reference substance name:
1-DODECENE DIMER, HYDROGENATED
IUPAC Name:
1-DODECENE DIMER, HYDROGENATED

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
arachis oil
Concentration / amount:
Concentration of test material and vehicle used at each stage of induction
a) Intradermal induction 25% (w/v) in dried arachis oil BP
b) Topical induction undiluted liquid as supplied

Concentration of test material and vehicle used at each stage of challenge
a) Undiluted liquid as supplied
b) 75% (w/v) in dried arachis oil BP
Challengeopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
arachis oil
Concentration / amount:
Concentration of test material and vehicle used at each stage of induction
a) Intradermal induction 25% (w/v) in dried arachis oil BP
b) Topical induction undiluted liquid as supplied

Concentration of test material and vehicle used at each stage of challenge
a) Undiluted liquid as supplied
b) 75% (w/v) in dried arachis oil BP
No. of animals per dose:
20 test animals and 10 control animals

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
75% w/v
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No skin reaction
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 75% w/v. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No skin reaction .
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
75% (w/v)
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No skin reaction
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 75% (w/v). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No skin reaction.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100% (w/v)
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No skin reaction
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100% (w/v). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No skin reaction.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100 % (w/v)
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No skin reaction
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 % (w/v). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No skin reaction.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
75% (w/v)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No skin reaction
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 75% (w/v). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No skin reaction.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
75% (w/v)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No skin reaction
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 75% (w/v). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No skin reaction.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100% (w/v)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No skin reaction
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100% (w/v). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No skin reaction.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100% (w/v)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No skin reaction
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100% (w/v). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No skin reaction.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Under the conditions of this study, the test material produced a 0% sensitization rate (0/20 animals) . The test material is not a skin sensitizer in the Magnusson & Kligman guinea pig maximization test. This finding does not warrant classification of the test material as a skin sensitizer under EU GHS guidelines and does not warrant classification under EU requirements for dangerous substances and preparations guidelines.
Executive summary:
A Magnusson-Kligman skin sensitization maximization test was carried out on 30 female albino Dunkin-Hartley guinea pigs (20 test and 10 control). The following concentrations of test material and vehicle were used at each stage of induction and at each stage of challenge: Intradermal induction - 25% w/v test material in dried arachis oil BP Topical induction - 100% test material (undiluted liquid as supplied) Topical challenge 75% w/v test material in dried arachis oil BP and 100% test material (undiluted liquid as supplied). On challenge, no skin reactions were noted at the application site in test group animals or in the control group at the 24 and 48 observations at either of the two concentrations. The test material produced a 0% sensitization rate in test (0/20) and control (0/10) animals. Hence, 1-dodecene dimer, hydrogenated is not a skin sensitizer in the Magnusson & Kligman guinea pig maximization test.