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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:
key study
Study period:
31 january 2003 to 4 february 2003
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
as the tested product is not the registered substance.
Justification for type of information:
As an ingredient used in medical devices, tests and protocols established from the O.E.C.D. guideline and International standard NF EN ISO 10993-10 concerning biological evaluation of medical devices are already available.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
animal weight and relative humidity
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
yes
Remarks:
animal weight and relative humidity
Principles of method if other than guideline:
Norm NF EN ISO 10993-10 (march 1996) Biological evaluation of medical devices.
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
available data (As an ingredient used in medical devices, tests and protocols established from the O.E.C.D. guideline and International standard NF EN ISO 10993-10 concerning biological evaluation of medical devices are already available.)

Test material

Constituent 1
Reference substance name:
Reaction mass of docosanoic acid and icosanoic acid and linoleic acid and linolenic acid and oleic acid and palmitic acid and stearic acid
EC Number:
946-247-6
Molecular formula:
Not relevant for a UVCB substance
IUPAC Name:
Reaction mass of docosanoic acid and icosanoic acid and linoleic acid and linolenic acid and oleic acid and palmitic acid and stearic acid
Test material form:
liquid
Details on test material:
The mixture contains 94.4 % of corn oil oxidised (glycerides, C10-20 and C10-20 unsat, oxidised).
Specific details on test material used for the study:
batch number 192

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
16 animals supplied by the centre of animal production (45160 Olivet - France).
They were kept during a minimal 5 day acclimatation period. During the test, animal weighed between 242 gr and 324 gr.
Kept in individual box at a temperature between 20°C and 23°C, and a relative humidity between 23% and 58%.

Study design: in vivo (non-LLNA)

Challenge
Route:
epicutaneous, open
No. of animals per dose:
8
Details on study design:
3 sites of exposure of 0.1 ml.

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
100%
No. with + reactions:
1
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
50%
No. with + reactions:
1
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation

Any other information on results incl. tables

table 1 : page 9/16 : research of the maximal concentration non nécrosante

tables 2 and 3 : page 10/16 : prelimirary test : macroscopic evaluation of cutaneous reaction

table 4 : page 11/16 : definitive test : global results : macroscopic evaluation of cutaneous reaction 24h and 48h

table 5 : page 12/16 : definitive test : individual results : macroscopic evaluation of cutaneous reaction

table 6 : page 13/16 : evolution of animal weights

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information
Conclusions:
The susbtance does not induce skin sensitization.