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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2016-01-12 to 2016-03-15
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented GLP compliant study report. The Maximization test was selected since the test item is a surfactant and the Local Lymph Node Assay as preferred alternative has shown to provide false positive results for surfactants.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
Methyl N-octadecylterephthalamate
EC Number:
230-836-3
EC Name:
Methyl N-octadecylterephthalamate
Cas Number:
7333-86-0
Molecular formula:
C27H45NO3
IUPAC Name:
methyl 4-(octadecylcarbamoyl)benzoate
Constituent 2
Chemical structure
Reference substance name:
N,N'-Dioctadecylterephthalamide
Cas Number:
37437-26-6
Molecular formula:
C44 H80 N2 O2
IUPAC Name:
N,N'-Dioctadecylterephthalamide
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

In vivo test system

Test animals

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

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
PRELIMINARY irritation study:
intradermal injections:
2%, 5%, 10%, 20%, the highest concentration being the maximum concentration that clould technical be injected.
Epidermal application
2%, 5%, 10%, 20%, the highest concentration being the maximum concentration that clould technical be applied. Based on the results in the initially treated animals, two additional animals were epidermally treated in a similar manner with 50% at a later stage.
MAIN-Study:
Induction:
- intradermal: test item at 5% concentration
- epidermal: 50% test item concentration
Challenge:
- epidermal: 50% test item concentration
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
PRELIMINARY irritation study:
intradermal injections:
2%, 5%, 10%, 20%, the highest concentration being the maximum concentration that clould technical be injected.
Epidermal application
2%, 5%, 10%, 20%, the highest concentration being the maximum concentration that clould technical be applied. Based on the results in the initially treated animals, two additional animals were epidermally treated in a similar manner with 50% at a later stage.
MAIN-Study:
Induction:
- intradermal: test item at 5% concentration
- epidermal: 50% test item concentration
Challenge:
- epidermal: 50% test item concentration
No. of animals per dose:
10
Positive control substance(s):
yes
Remarks:
ALPHA-HEXYLCINNAMICALDEHYDE

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none observed
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50% . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none observed.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none observed
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 % . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none observed.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
test item at 50%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: test item at 50%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
test item at 50%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: test item at 50%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
20%
No. with + reactions:
7
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 20%. No with. + reactions: 7.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
20 %
No. with + reactions:
6
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 20 %. No with. + reactions: 6.0. Total no. in groups: 10.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
There was no evidence that HOSTAGEL HT 300 had caused skin hypersensitivity in the guinea pig, since no responses were observed in the experimental animals in response to a 50% test item concentration in the challenge phase. This result indicates a sensitization rate of 0 per cent.
Executive summary:

In order to assess the potential of the test item to induce skin sensitization a Magnusson & Kligman maximization study in guinea pigs according to OECD 406 guideline was performed.

Test item concentrations selected for the main study were based on the results of a preliminary study. In the main study, ten experimental animals were intradermally injected with a 5% concentration and epidermally exposed to a 50% concentration. Five control animals were similarly treated, but with vehicle alone (corn oil). Approximately 24 hours before the epidermal induction exposure all animals were treated with 10% SDS. Two weeks after the epidermal application all animals were epidermally challenged with a 50% test item concentration and the vehicle. No skin reactions were evident after the challenge exposure in the experimental and control animals.

There was no evidence that HOSTAGEL HT 300 had caused skin hypersensitivity in the guinea pig, since no responses were observed in the experimental animals in response to a 50% test item concentration in the challenge phase. This result indicates a sensitization rate of 0 per cent.

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