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Diss Factsheets

Administrative data

Description of key information

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

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August 5, 2002 - September 19, 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
The MNNC was carried out at 25%, 12.5%, 6.25% and 3.125% in paraffin oil and diluted at 16% and 8% in ethanol/water 1 animal weighted 233g at the beginning instead of 250g These deviations have no influence on the development and the results of the study
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Test performed in 2002.
LLNA method (OECD 442 B) was adopted in 2010.
Species:
guinea pig
Strain:
Dunkin-Hartley
Remarks:
albinos
Sex:
male
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 5-day acclimatisation period. For the main study, the animals weighted between 233g and 353g at the beginning of the test.
Route:
intradermal
Vehicle:
other:
Concentration / amount:
08/25/02: First induction
- 2 intradermal injections of the product diluted at 16% in an ethanol/distilled water (20/80: v/v) solution.
- 2 intradermal injections of Freund’s Complete Adjuvant diluted at 50% in a physiological saline solution.
- 2 intradermal injections of a mixture with equal volumes - Freund’s Complete Adjuvant at 50% and the product diluted at 32% in a ethanol/distilled water (20/80: v/v) solution.

08/30/02: Second 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%.
Route:
epicutaneous, occlusive
Concentration / amount:
09/16/02: topical application under occlusive dressing at the
following concentrations : 100% and 50%.
09/17/02: 24-hours reading time.
09/18/02: 48-hours reading time and weighing.
No. of animals per dose:
GROUP 1 (negative control) : 5 male guinea pigs identified n° C7276 to C7280;
GROUP 2 (treated) : 10 male guinea pigs identified n° C7291 to C7300;
Details on study design:
Preliminary studies
08/01/02 Arrival of animals.
08/05/02 to 09/04/02 Preliminary tests : pre MNIC, MNNC, and MNIC determinations.

Main study
08/20/02 Arrival of animals.
Induction phase
08/25/02 1st induction
- 2 intradermal injections of the product diluted at 16% in an
ethanol/distilled water (20/80: v/v) solution.
- 2 intradermal injections of Freund’s Complete Adjuvant diluted at 50% in a
physiological saline solution.
- 2 intradermal injections of a mixture with equal volumes - Freund’s
Complete Adjuvant at 50% and the product diluted at 32% in a
ethanol/distilled water (20/80: v/v) solution.
08/25/02 Weighing of animals.
08/30/02 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%.
09/01/02 to 09/16/02 Rest phase: 15 days
09/16/02 Challenge phase : topical application under occlusive dressing at the following concentrations : 100% and 50%.
09/17/02 24-hours reading time.
09/18/02 48-hours reading time and weighing.
Positive control substance(s):
yes
Positive control results:
In conclusion, in view of these results, under these experimental conditions, the substances
NEOMYCIN SULFATE and BENZOCAINE :
must be classified R 43 “may cause sensitization by skin contact” and in accordance with the
criteria for classification, packaging and labelling of dangerous substances of the E.E.C. Directives
67/548 and 2001/59.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
5
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
5
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
5
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
5
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
25%
No. with + reactions:
5
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
25%
No. with + reactions:
5
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
12.5%
No. with + reactions:
5
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:
12.5%
No. with + reactions:
4
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:
test chemical
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
Interpretation of results:
GHS criteria not met
Conclusions:
In view of these results, under these experimental conditions, the test item, in accordance with the criteria for classification, packaging and labelling of dangerous substances of the E.E.C. Directives 67/548 and 99/45, must not be classified.
Executive summary:

SUMMARY AND CONSLUSION OF THE STUDY


After induction (intradermic injection and topical application) of 10 animals (male) of treated group with the test item and a 15-days rest phase, the challenge phase, under occlusive dressing for 24 hours, consisted to a single topical application of the test product at 100% and diluted at 50% in an ethanol/distiller water solution (20/80, v/v), 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 test item, must not be classified and in accordance with the criteria for classification, packaging and labelling of dangerous substances of the E.E.C. Directives 67/548 and 99/45.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Justification for classification or non-classification