Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Strating material and the final product which are of very similar structure and functionality are not sensitising.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
not specified
Type of study:
patch test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
BDF is the final product produced from difluorodiphenly methane and only difference being thje removal of a methyl group for a ketone.

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: spf:-derived albino strain
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: DMF
Concentration / amount:
10%, 1% & 0.1%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: DMF
Concentration / amount:
10%, 1% & 0.1%
No. of animals per dose:
Unknown
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
10%
No. with + reactions:
0
Total no. in group:
3
Clinical observations:
No erythematous reactions.
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: 3.0. Clinical observations: No erythematous reactions..

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
We have classified this material as not sensiting due to our extensive experience in handling this substance and the animal testing completed on a very similar chemical.