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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:
guideline study
Justification for type of information:
No in vitro test was proposed because this guinea pig test was done in 2004 and no in vitro test existed at that time (OECD tests n°442 C and D adopted in 2015)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
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)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
No in vitro test was proposed because this guinea pig test was done in 2004 and no in vitro test existed at that time (OECD tests n°442 C and D adopted in 2015)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The product LCE03072, sent by SEPPIC – Avenue Lacaze Basse –F-81105 CASTRES, was received
on 22 December 2003. Its characteristics were :
· Container : plass flask
· Form : liquid
· Quantity : 154.84 g (container + contents)
· Colour : colorless
· Batch : -
· Storage : room temperature
· CAS N° : -
· Purity : -
It was identified under the code number: PH-03/0428.

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
15 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 6-day acclimatisation period. For the main study, the animals weighted between 246g and 350g at the beginning of the test.

The environmental parameters were :
- Temperature : between 19°C and 26°C
- Relative humidity : between 30% and 66%

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
physiological saline
Concentration / amount:
Induction phase
1st induction
- 2 intradermal injections of the product diluted at 12.5% in physiological saline solution.
- 2 intradermal injections of Freund’s Complete Adjuvant diluted at 50% in physiological saline solution.
- 2 intradermal injections of a mixture with equal volumes - Freund’s Complete Adjuvant at 50% and the product diluted at 25% in physiological
saline solution
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%.

Challenge phase : topical application under occlusive dressing at the following concentrations : 50% & 25%.
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
Induction phase
1st induction
- 2 intradermal injections of the product diluted at 12.5% in physiological saline solution.
- 2 intradermal injections of Freund’s Complete Adjuvant diluted at 50% in physiological saline solution.
- 2 intradermal injections of a mixture with equal volumes - Freund’s Complete Adjuvant at 50% and the product diluted at 25% in physiological
saline solution
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%.

Challenge phase : topical application under occlusive dressing at the following concentrations : 50% & 25%.
No. of animals per dose:
GROUP 1 (negative control) : 5 female guinea pigs identified n° C9296 to C9300;
GROUP 2 (treated) : 10 female guinea pigs identified n° C9311 to C9320.

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
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:
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:
negative control
Dose level:
25%
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: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
25%
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: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50%
No. with + reactions:
0
Total no. in group:
9
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: 9.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
50%
No. with + reactions:
0
Total no. in group:
9
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: 9.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
25%
No. with + reactions:
0
Total no. in group:
9
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 9.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
25%
No. with + reactions:
0
Total no. in group:
9
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 9.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
In view of these results, under these experimental conditions, the product LCE03072, 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 10 Guinea Pigs (female) of treated group with the test product LCE03072 and a 18-days rest phase, the challenge phase, under occlusive dressing for 24 hours, consisted to a single topical application of the test product diluted at 50% and at 25% in distilled water, 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 conclusion, in view of these results, under these experimental conditions, the product LCE03072, 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.