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Description of key information


In Compliance with the OECD Guidelines 406 (Skin Sensitisation) test:

An experimental study to determine the skin sensitizing potential of the test item, the induction of the possible sensitizing effect was performed by epicutaneous and intradermal routes: Freund's Compete Adjuvant is used to increase sensitivity.

According to the 67/548/EEC directive, the test preparation Ref CS81503 was considered as not sensitizing by contact with the skin.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 1998-04-30 to 1998-06-06
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
Maximalisation
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Test performed in 1998. LLNA method (OECD 442 B) was adopted in 2010 and also the (OECD tests n°442 C , D) was adopted in 2015
Species:
guinea pig
Strain:
Hartley
Sex:
female
Details on test animals and environmental conditions:
Supplier: Charles River (76410 Saint Aubin les Elbeuf, France)
Weight: between 331 and 385 g at the beginning of the study (main test)
Acclimatization: at least 5 days
Housing, diet: in individual polypropylene cage in accordance with the requirement of the 86/609/EEC guideline. Complete pelleted diet UAR 106 (91360-Epinay sur Orge, France)
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
Concentration of test material and vehicle used in induction:
injection: 0.5 % in distilled water
Topical application: 0.5mL of the preparation diluted at 10%, occlusive dressing for 48 hours

Concentration of test material and vehicle used for each challenge:
0.2mL at 1 % in distillled water, occlusive patch (MNIC), for 24 hours
0.2 mL at 0.5% in distilled water (MNIC/2), for 24 hours
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Concentration of test material and vehicle used in induction:
injection: 0.5 % in distilled water
Topical application: 0.5mL of the preparation diluted at 10%, occlusive dressing for 48 hours

Concentration of test material and vehicle used for each challenge:
0.2mL at 1 % in distillled water, occlusive patch (MNIC), for 24 hours
0.2 mL at 0.5% in distilled water (MNIC/2), for 24 hours
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 5
Details on study design:
Induction
-intradermal injections
Each guinea pig was clipped at the dorsal level. It received, on both sides of the spinal column, at the specular level, 3 symetrical intradermal injections of 0.1 mL for the following preparations
for group 1:
injection1: mixture 1:1 (v/v) of Freund's Complete Adjuvabt (FCA) and distilled water
inj 2: vehicle (distilled water)
inj 3 : 50 % of ditilled water in a mixture 1/1 (v/v) of FCA and distilled water
for group2:
inj 1: mixture 1:1 (v/v) of FCA and distilled water
inj 2: test material diluted at 0.5% with distilled water
inj 3: test material diluted at 0.5% with a wixture 1:1 (v/v) of FCA and distilled water
- Topical application
After 6 days of rest period, the 15 guinea pigs (group 1 and 2) were clipped at the injection sites. As the test material was a skin irritant, the test area of control and treated animals was not painted with 0.5 mL of 10% Sodium Lauryl Sulfate in petrolatum.
24 hours later, we applied to the rest area, on each of the guinea-pigs from group 2, a piece of filter paper Whatman completely impregnated with 0.5 mL of the preparation diluted at 10 % with distilled water, held in contact with the skin by an occlusive dressing for 48 hours.
The guinea pigs from group 1 received in a similar manner 0.5 mL of distilled water.

Challenge: topical application
after a 12 day rest period (instead of 11 days) the guinea pigs from both groups were clipped one last time at the dorso-lumbar region, the skin surface chosen corresponding to a zone which had not previously been in contact with the tested product.
We applied under an occlusive patch, to the skin of each of the guinea pigs from groups 1 and 2, two pieces of filter impregnated with 0.2 mL of the tested product to its maximal non irritant concentration (MNIC: 1% in distilled water) and to a lower concentration (0.5 % : MNIC /2)
The occlusive patches were held in place for 24 hours the removed.
Approximately 21 hours after patch removal, the challenge test area was cleaned and clipped if necessary.
3 hours later, we observed and noted the cutaneous reaction withan appropriate scale.
24 and 48 hours later, two other observations were performed and recorded.
In case of doubt, a second challenge test can be carried out 10 days later on an untouched skin region, using a new control or the original control group.
Positive control substance(s):
no
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.5 %
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
1 %
No. with + reactions:
1
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
0.5 %
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
1 %
No. with + reactions:
1
Total no. in group:
10
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test group
Dose level:
0.5%
No. with + reactions:
0
Total no. in group:
10
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test group
Dose level:
1%
No. with + reactions:
1
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.5 %
No. with + reactions:
0
Total no. in group:
5
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
1 %
No. with + reactions:
0
Total no. in group:
5
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.5 %
No. with + reactions:
0
Total no. in group:
5
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
1 %
No. with + reactions:
0
Total no. in group:
5
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
negative control
Dose level:
0.5%
No. with + reactions:
0
Total no. in group:
5
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
negative control
Dose level:
1%
No. with + reactions:
0
Total no. in group:
5
Group:
positive control
Remarks on result:
not measured/tested
Remarks:
No positive control was performed.

Maximum concentration not causing irritating effects in preliminary test: 1 %


Signs of irritation during induction:

none


Evidence of sensitisation of each challenge concentration:

one animal showed a very slight erythema (index 1) in the

challenge test at 1 % 


Other observations:

weight evolution remain normal

Interpretation of results:
other: not classified
Conclusions:
According to the 67/548/EEC directive, the test preparation Ref CS81503 should be considered as not sensitizing by contact with the skin.
Executive summary:

Test objective: to determine the skin sensitizing potential of a substance. the induction of the possible sensitizing effect is performed by epicutaneous and intradermal routes: Freund's Compete Adjuvant is used to increase sensitivity.

This study is conduced according to the 406 OECD guidelines in compliance with the Good Laboratory Pratices.

According to the 67/548/EEC directive, the test preparation Ref CS81503 should be considered as not sensitizing by contact with the skin.

Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Justification for classification or non-classification

Classified as Not sensitizing by contact with the skin:

Based on the results to determine the skin sensitizing potential of the test item, the induction of the possible sensitizing effect performed by epicutaneous and intradermal routes.

According to the 67/548/EEC directive, the test preparation Ref CS81503 was considered as not sensitizing by contact with the skin.