Registration Dossier

Administrative data

Description of key information

Under the retained experimental conditions Pine tar may be classified as sensitizer.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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
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
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.
Positive control results:
Positive controls showed results that are met in OECD validation dataset, between 7 µM and 30 µM.
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
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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Under the retained experimental conditions Pine tar may be classified as sensitizer.