Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Indole is skin sensitiser. Skin sens 1. (H317) May cause an allergic skin reaction.

The skin sensitization of the target Indole was predicted employing two different in silico approaches: the QSAR statistical model as provided by Vega and the decision rule system provided by Toxtree. In the case of the target Indole, Toxtree did not identify any skin sensitization reactivity domain alert, while Vega provided a positive prediction of moderate reliability. Thus, following a conservative approach, it was concluded that the target compound Indole is predicted as SKIN SENSITIZER and the prediction was assessed as moderate reliable.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in chemico
Remarks:
QSAR
Type of information:
(Q)SAR
Adequacy of study:
key study
Study period:
2017
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
Justification for type of information:
QSAR
Principles of method if other than guideline:
QSAR
GLP compliance:
no
Details on the study design:
The skin sensitization of the target Indole was predicted employing two different in silico approaches: the QSAR statistical model as provided by Vega and the decision rule system provided by Toxtree. In the case of the target Indole, Toxtree did not identify any skin sensitization reactivity domain alert, while Vega provided a positive prediction of moderate reliability. Thus, following a conservative approach, it was concluded that the target compound Indole is predicted as SKIN SENSITIZER and the prediction was assessed as moderate reliable.
Key result
Run / experiment:
other: : the QSAR statistical model as provided by Vega and the decision rule system provided by Toxtree.
Parameter:
other: Skin sensitisation
Remarks:
QSAR
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
not specified
Remarks on result:
positive indication of skin sensitisation
Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
The skin sensitization of the target Indole was predicted employing two different in silico approaches: the QSAR statistical model as provided by Vega and the decision rule system provided by Toxtree. In the case of the target Indole, Toxtree did not identify any skin sensitization reactivity domain alert, while Vega provided a positive prediction of moderate reliability. Thus, following a conservative approach, it was concluded that the target compound Indole is predicted as SKIN SENSITIZER and the prediction was assessed as moderate reliable.

Indole is skin sensitiser. Skin sens 1. (H317) May cause an allergic skin reaction.
Executive summary:

Indole is skin sensitiser. Skin sens 1. (H317) May cause an allergic skin reaction.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

Indole is skin sensitiser. Skin sens 1. (H317) May cause an allergic skin reaction.

Justification for classification or non-classification