Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
not given
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only summary available, no individual data given
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
not specified
Principles of method if other than guideline:
Sensitization was induced in guinea pigs by intradermal injections of the test substance and complete Freunds Adjuvant. The induction process was supplemented 7 days later by application of ATBC to the shoulder injection sites under occlusion. Fourteen days later the animals were challenged by occluded patches. Challenges were repeated after 1 week. Evaluations for contact sensitization were performed at 24 and 48 hours after patch removal.
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Exisiting study
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
no data
Route:
intradermal
Vehicle:
no data
Concentration / amount:
no data
Route:
epicutaneous, occlusive
Vehicle:
no data
Concentration / amount:
no data
No. of animals per dose:
no data
Details on study design:
no further data
Challenge controls:
no data
Positive control results:
no data
Remarks on result:
no indication of skin sensitisation

Evaluations for contact sensitization were performed at 24 and 48 hours after patch removal.

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
ATBC is not considered to have a sensitising potential.
Executive summary:

ATBC was found to be non sensitizing to the skin of Guinea pigs following the method Magnusson and Kligman's Guinea pig Maximumization test.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

ATBC was tested both in a GPMT as well as in humans with a repeated insult patch test. Although these studies were not published with full documentation, it can be concluded that ATBC will not cause skin sensitization.


Migrated from Short description of key information:
ATBC was tested both in a GPMT as well as in humans with a repeated insult patch test. Both studies gave no indication for possible skin sensitization.

Justification for selection of skin sensitisation endpoint:
The available studies.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

There is no indication that ATBC may cause respiratory sensitisation.


Justification for selection of respiratory sensitisation endpoint:
No further study is needed since ATBC is not sensitizer and it is marginally available in the air for inhalation.

Justification for classification or non-classification

ATBC was tested both in a GPMT as well as in humans with a repeated insult patch test. Although these studies were not published with full documentation, it can be concluded that ATBC will not cause skin sensitization. Therefore ATBC is not subject for classification.