Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vitro
Type of information:
experimental study
Adequacy of study:
key study
Study period:
30.5.-10.6.2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Certificate attached in the study report
Type of study:
activation of keratinocytes

Test material

Reference
Name:
Unnamed
Test material form:
liquid

In vitro test system

Details on study design:
Cells seeding was performed on the first day. The preparation of the test item dilutions were conducted the following day. Test system included negative and postivi controls. According to protocol, contact between the cells and the test and reference items were made during the second day. The day four consisted Luciferace activity observations and cell viability assessment with MTT method.

Results and discussion

Positive control results:
Positive controls showed results that are met in OECD validation dataset, between 7 µM and 30 µM.

In vitro / in chemico

Results
Key result
Parameter:
other: viability / induction
Run / experiment:
Mean
Value:
ca.
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
positive indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
Under the retained experimental conditions Pine tar may be classified as sesitizer.
Executive summary:

The pine tar was studied for sensitising properties using Keratinosens test. Under the retained experimental conditions Pine tar may be classified as sensitizer.