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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
january 1976 - february 1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
no guideline available
Guideline:
other: Identification of Contact Allergens by Guinea Pig Maximization test ( Magnusson / Kligman)
GLP compliance:
no
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium [2-[(2,6-dichlorophenyl)amino]phenyl]acetate
EC Number:
239-346-4
EC Name:
Sodium [2-[(2,6-dichlorophenyl)amino]phenyl]acetate
Cas Number:
15307-79-6
Molecular formula:
C14H11Cl2NO2.Na
IUPAC Name:
sodium {2-[(2,6-dichlorophenyl)amino]phenyl}acetate

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
physiological saline
Concentration / amount:
induction: 0.1 ml of complete Freund`s adjuvant, diluted 1:1 with distilled water (intracutaneous)
induction: 0.1 ml of a 5% solution of Diclofenac Sodium Salt (intracutaneous)
induction: 0.5 ml of a 10% solution Diclofenac Sodium Salt (applied to the dorsal skin)
challenge: 0,1 ml of a 10% solution Diclofenac Sodium Salt (applied to the flank skin)
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
induction: 0.1 ml of complete Freund`s adjuvant, diluted 1:1 with distilled water (intracutaneous)
induction: 0.1 ml of a 5% solution of Diclofenac Sodium Salt (intracutaneous)
induction: 0.5 ml of a 10% solution Diclofenac Sodium Salt (applied to the dorsal skin)
challenge: 0,1 ml of a 10% solution Diclofenac Sodium Salt (applied to the flank skin)
No. of animals per dose:
20 animals for the test preparation and 20 animals for the control

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
not detected
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: not detected.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According the classification criteria described in REGULATION (EC) No 1272/2008 (CLP), the product has not to be classified as a sensitizer.