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Toxicological information

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD guideline, GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
2003-05-20
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Test performed in 2004.
LLNA method (OECD 442 B) was adopted in 2010.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
· Container : plastic flask (n=1)
· Form : solid
· Quantity : 78.41 g (container + contents)
· Colour : yellow
· Batch : 0214400005
· Storage : room temperature
· CAS N° : -
· Purity : -
It was identified under the code number: PH-04/0095.

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male
Details on test animals and environmental conditions:
For the main study, sixteen male albino guinea pigs of Dunkin-Hartley strain, supplied by Centre de Production animale (F-45160 Olivet) were exposed to the test product after a 5-day acclimatisation period. The animals weighted between 299 g and 375 g at the beginning of the test.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
olive oil
Concentration / amount:
Induction phase (Group 2)
1st induction
- 2 intradermal injections of the product diluted at 0.75% in olive oil.
- 2 intradermal injections of Freund’s Complete Adjuvant diluted at 50% in
in olive oil.
- 2 intradermal injections of a mixture with equal volumes - Freund’s
Complete Adjuvant at 50% and the product diluted at 1.5% in olive oil.
Weighing of animals.
2nd induction: topical application, on the same zone, with the product at
100%, 24 hours after brushing with 0.5 ml of a solution of Sodium lauryl
sulfate at 10%.
Rest phase: 18 days
Challenge phase (Groups 1 & 2): topical application under occlusive
dressing at the following concentrations : 100% & 50%.
24-hours reading time.
48-hours reading time and weighing.
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
olive oil
Concentration / amount:
Induction phase (Group 2)
1st induction
- 2 intradermal injections of the product diluted at 0.75% in olive oil.
- 2 intradermal injections of Freund’s Complete Adjuvant diluted at 50% in
in olive oil.
- 2 intradermal injections of a mixture with equal volumes - Freund’s
Complete Adjuvant at 50% and the product diluted at 1.5% in olive oil.
Weighing of animals.
2nd induction: topical application, on the same zone, with the product at
100%, 24 hours after brushing with 0.5 ml of a solution of Sodium lauryl
sulfate at 10%.
Rest phase: 18 days
Challenge phase (Groups 1 & 2): topical application under occlusive
dressing at the following concentrations : 100% & 50%.
24-hours reading time.
48-hours reading time and weighing.
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 5

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
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.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
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.
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:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 5.0.
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:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0.
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:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 5.0.
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:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
12.5%
No. with + reactions:
4
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
12.5%
No. with + reactions:
5
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
6.25%
No. with + reactions:
4
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
6.25%
No. with + reactions:
5
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
75%
No. with + reactions:
4
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
75%
No. with + reactions:
4
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
38%
No. with + reactions:
3
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
38%
No. with + reactions:
4
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
75%
No. with + reactions:
4
Total no. in group:
9
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
75%
No. with + reactions:
3
Total no. in group:
9
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
38%
No. with + reactions:
4
Total no. in group:
9
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
38%
No. with + reactions:
3
Total no. in group:
9

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information not classified
Conclusions:
In view of these results, under these experimental conditions, the product LCA04005, in accordance
with the criteria for classification, packaging and labelling of dangerous substances and preparations
of the E.E.C. Directives 67/548, 2001/59 and 99/45, must not be classified
Executive summary:

After induction (intradermic injection and topical application) of 11 Guinea Pigs of treated group with the test product LCA04005 and a 18-day rest phase, the challenge phase, under occlusive dressing for 24 hours, consisted to a single topical application of the test product pure (100%) and diluted at 50% in paraffin oil, according to the experimental protocol established from the O.E.C.D. guideline n°406 dated July 17th, 1992 and the method B.6 of the E.E.C. n°96/54 dated July 30th, 1996.

No macroscopic cutaneous reactions attributable to allergy was recorded during the examination following the removal of the occlusive dressing (challenge phase) from the animals of the treated group with the test product.

No cutaneous intolerance reaction was recorded in animals from the negative control group.

In view of these results, under these experimental conditions, the product LCA04005, in accordance with the criteria for classification, packaging and labelling of dangerous substances and preparations of the E.E.C. Directives 67/548, 2001/59 and 99/45, must not be classified.