6-cyclohexyl-1-hydroxy-4-methylpyridin-2(1H)-one, compound with 2-aminoethanol (1:1)

Endpoint summary

Description of key information

Human data on a product containing 0.77% of ciclopirox olamine confirms that this substance at this concentration is not sensitizing. No data are available in literature about neat substance. Ciclopirox olamine is an organic salt; the assessment of sensitizing potential was focused on its dissociation products.

6-cyclohexyl-4-methyl-2-oxopyridin-2(1H)-olate anion is considered as skin sensitizer, according to the available QSAR data , but this prediction is little reliable.

2-aminoethanol (MEA) , the neutral form of ethanolminium cation, is not sensitizing in animals. However, available information about MEA in humans is ambiguous as there are negative but also several reports of dermatitis and positive epicutaneous test reactions to MEA.

Concern about Ciclopirox olamine sensitizing potential exists, therefore, from a worst case point of view, the substance is classified as Skin Sens.1, H317 according to Regulation (EC) n. 1272/2008 (CLP)

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Reference 1

Endpoint:

skin sensitisation, other

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Principles of method if other than guideline:

Data published on sensitizing potential for 2-aminoethanol, neutral form of ethanolaminium cation.

GLP compliance:

not specified

Species:

other: laboratory animals

Reading:

other: sensitizing potential

Remarks on result:

no indication of skin sensitisation

Interpretation of results:

GHS criteria not met

Conclusions:

2-aminoethanol (MEA) , the neutral form of ethanolminium cation, is not sensitizing in animals. However, available information about MEA in humans is ambiguous as there are negative but also several reports of dermatitis and positive epicutaneous test reactions to MEA.

Reference 2

Endpoint:

skin sensitisation, other

Type of information:

(Q)SAR

Adequacy of study:

supporting study

Study period:

2016

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

results derived from a valid (Q)SAR model, but not (completely) falling into its applicability domain, with adequate and reliable documentation / justification

Justification for type of information:

see attached "Report CAS 29342-05-0"

Principles of method if other than guideline:

Derek Nexus; Toxtree; Vega (see atteched "Report CAS 29342-05-02)

Conclusions:

6-cyclohexyl-4-methyl-2-oxopyridin-2(1H)-olate anion is considered as skin sensitizer, according to the available QSAR data.

Reference 3

Endpoint:

skin sensitisation, other

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Principles of method if other than guideline:

Human data on a product containing ciclopirox olamine

Specific details on test material used for the study:

Product containing 0.77% of ciclopirox olamine

Species:

other: Human data

Reading:

other:

Parameter:

other: sensitizing potential

Remarks on result:

other: not sensitizing

Interpretation of results:

study cannot be used for classification

Conclusions:

Human data on a product containing 0.77% of ciclopirox olamine confirms that this substance at this concentration is not sensitizing (U.S. National Library of Medicine, Ciclopirox olamine cream).

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available