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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

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 palmitic acid and stearicacid and linoleic acid and oleic acid and docosanoic acid and linolenic acid and icosanoic acid
Molecular formula:
Not relevant for a UVCB substance
IUPAC Name:
Reaction mass of palmitic acid and stearicacid and linoleic acid and oleic acid and docosanoic acid and linolenic acid and icosanoic 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
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100%
No. with + reactions:
2
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
3
Total no. in group:
10
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.