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:
Danish QSAR study for CAS No.: 99-34-3
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: Modelling Database
Principles of method if other than guideline:
Multicase model A33 used for estimation of the result
GLP compliance:
no
Type of study:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
other: no data
Strain:
not specified
Sex:
not specified

Study design: in vivo (non-LLNA)

Induction
Route:
other: no data
Vehicle:
no data
Challenge
Route:
other: no data
Vehicle:
no data

Study design: in vivo (LLNA)

Vehicle:
not specified

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Group:
test group
Clinical observations:
Skin sensitization : Positive
Remarks on result:
other: Reading: 1st reading. Group: test group. Clinical observations: Skin sensitization : Positive .

In vivo (LLNA)

Results
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: no data

Any other information on results incl. tables

Skin sensitization : Positive

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Skin sensitization : Positive