Registration Dossier

Administrative data

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: Before BPL and guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EU Method B.6 (Skin Sensitisation)
Principles of method if other than guideline:
ASA: in an isotonic phosphate buffer at pH7. The volume injected in each case was 0.1 ml. The 5 injections were administered on Days 0, 2, 5, 8 and 12.On Day 16, the contact solution was applied. Each time, we used a mixture of acetone-almond oil in a 1:1 ratio (V:V).
GLP compliance:
no
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Concentration / amount:
200 and 100 mg/ml
Challengeopen allclose all
Route:
epicutaneous, occlusive
Concentration / amount:
200 and 100 mg/ml
No. of animals per dose:
10
Positive control substance(s):
yes
Remarks:
acetylsalicylic acid anhydride (ASAN)

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
200 mg/mL
No. with + reactions:
0
Total no. in group:
0
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 200 mg/mL. No with. + reactions: 0.0. Total no. in groups: 0.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
ASA is not sensitizing in a guinea pig test comparable to maximisation.
Executive summary:

ASA tested at high doses ( induction at 200 and 100 mg/ml intracutaneous) in guinea pigs, with a normal amount ( 0.01%) od the sensitising impurity ASAN, was totally negative in ths assay.