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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:
from 1998-04-30 to 1998-06-06
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
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

Test material

Constituent 1
Reference substance name:
CS81503
IUPAC Name:
CS81503
Details on test material:
Appearence: white cristallized powder
Received: 1998-04-27
Laboratory reference: 98-1423
Storage: at room temperature, away from the light

In vivo test system

Test animals

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)

Study design: in vivo (non-LLNA)

Inductionopen allclose all
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
Challengeopen allclose all
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

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Group:
positive control
Remarks on result:
not measured/tested
Remarks:
No positive control was performed.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.5 %
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1 %
No. with + reactions:
1
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5 %
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1 %
No. with + reactions:
1
Total no. in group:
10
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
0.5%
No. with + reactions:
0
Total no. in group:
10
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test chemical
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

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.

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