Registration Dossier

Administrative data

Description of key information

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study is not done according to OECD guideline. But it is a well documented study.
Reason / purpose:
reference to same study
Qualifier:
no guideline followed
Principles of method if other than guideline:
The ears were measured using an engineer’s micrometre. The test compound in solution was applied to the left ear of each animal (test and control) and the solvent was applied to the right ear. At both 24 and 48 hr after this challenge, the thicknesses of both ears measured. Positive responses were defined on an animal-by-animal basis as cases where the test ear demonstrated at least a 20% greater thickness than the control ear. % ear swelling = test ear thickness / control ear thickness x 100
As a starting point, test groups of 10 mice each and irritation control groups of 5 mice each were used. With 6- to 8-old female mice and DNCB as an allergen, combinations of inductions on Days 0 and 3; 0 and 7; 0,3, and 7; and 0, 1,2, and 3 were compared. A volume of 100 µl of test material solution or mixture was topically applied to a I-in-square central section of the stomach with an Eppendorf pipet. The responsiveness of male and female 6- to 8-week old CF-1 mice was evaluated using oxazolone and TDI with intradermal injections of Freund’s complete adjuvant emulsion (FCA)4 on Day 0 followed by tape stripping and topical application of 100 µl of test material in solvent to the stomach regions on Days 0, I, 2, and 3. On Day 10, 20 µl of test material was applied to one ear (10 µl to each side) while 20 µl of solvent alone was applied to the other.
GLP compliance:
not specified
Type of study:
mouse ear swelling test
Justification for non-LLNA method:
The study provides appropriate data. Therefore, further animal testing is not necessary.
Species:
mouse
Strain:
CF-1
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories
- Age at study initiation: 6-8 weeks
- Housing: five per cage in wire-bottom stainless-steel cages and allowed water and feed
- Water (e.g. ad libitum): ad libitum
Route:
intradermal
Vehicle:
other: Acetone
Concentration / amount:
10 % (Basis for selection of concentration: solubility)
Route:
intradermal
Vehicle:
other: Acetone
Concentration / amount:
10 % (Basis for selection of concentration: solubility)
No. of animals per dose:
Test group: 10 animals
Control group: 5-10 animals
Details on study design:
RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Day(s) of exposure: 1;2;3
- Test groups: 10 animals 100 µl of test substance in vehicle
- Control group: 5-10 100 µl of vehicle
- Concentrations: 10 %

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 10
- Concentrations: 20 µl of test substance in vehicle or 20 µl of vehicle
- Control group: 20 µl of test substance in vehicle and 20 µl of vehicle
- Site: left and right ear
- Concentrations: 10 %
- Evaluation (hr after challenge): 24 and 48
Positive control substance(s):
no
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
20 µl of test substance (10 %) in vehicle or 20 µl of vehicle
No. with + reactions:
0
Total no. in group:
10

Salicylic acid did not induce sensitization in mice in the mouse Ear Swelling Test (MEST). No animal of the test group showed a reaction in the challenge test with 10 % salicylic acid after 24 h. No mice were sensitized.


% swelling = [(test ear thickness) / (control ear thickness)] x 100 = 102%

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Salicylic acid is a not sensitising.
Executive summary:

The contact sensitivity of salicylic acid was experimentally evaluated in mice, using the method of Mouse Ear Swelling Test (MEST). CF-1 female mice, 6 to 8 weeks old were used for these studies. In this study, it is shown that, salicylic acid is not a dermal sensitizer.

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

The contact sensitivity of the read across substance salicylic acid was experimentally evaluated in mice, using the method of Mouse Ear Swelling Test (MEST). CF-1 female mice, 6 to 8 weeks old were used for these studies. In this study, it is shown that, salicylic acid is not dermal sensitizing.

Migrated from Short description of key information:

The read across substance salicylic acid is a not sensitising.

Justification for selection of skin sensitisation endpoint:

Study is not done according to OECD guideline, but it is a well documented study.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The read across substance salicylic acid is a not sensitising and does not need to be classified. Therefore, we conclude that quinic acid is not sensitizing, too and does not need to be classified.