Registration Dossier

Administrative data

Endpoint:
skin sensitisation
Remarks:
in vivo
Type of information:
calculation (if not (Q)SAR)
Remarks:
Migrated phrase: estimated by calculation
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
other: Authoritative data base
Title:
CAS No.: 95-64-7
Author:
Danish EPA Model
Year:
2012
Bibliographic source:
QSAR predictions by Danish Environmental Protection Agency (EPA)model powered by OASIS database; Commercial

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Estimation database
Principles of method if other than guideline:
Multicase model A33, data from GPMT or human experience (ACD Humans)
GLP compliance:
no
Type of study:
other: estimation

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
other: unspecified
Strain:
not specified
Sex:
not specified

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal
Vehicle:
unchanged (no vehicle)
Challenge
Route:
intradermal
Vehicle:
unchanged (no vehicle)

Results and discussion

In vivo (non-LLNA)

Results
Reading:
other: estimation
Group:
test group
Dose level:
no data
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
Skin sensitization: sensitising (Positive)
Remarks on result:
other: Reading: other: estimation. Group: test group. Dose level: no data. No with. + reactions: 0.0. Total no. in groups: 0.0. Clinical observations: Skin sensitization: sensitising (Positive).

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

Skin sensitization: Sensitising (Positive) estimation values have been obtained for 3,4 xylidine. The estimation method used for the process is Multicase models.