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 the substance at this concentration is not skin irritant. No data are available in literature about neat substance. Therefore, data about dissociation products of the salt have been evaluated.

6-cyclohexyl-4-methyl-2-oxopyridin-2(1H)-olate anion is considered as not skin and eye irritant, according to the available QSAR data on its neutral form, ciclopirox.

2 -aminoethanol (MEA) , the neutral form of ethanolminium cation, instead is considered corrosive or irritating to eyes, skin, respiratory tract, and/or site of contact (CAS number: 141-43-5). Indeed, according to the previous cited report, MEA is corrosive to the skin and corrosive or causes severe eye irritation in laboratory animals. It had been classified as Skin Corr. 1B, H314 according to Regulation (EC) n. 1272/2008 (CLP).

From a precautionary point of view, Ciclopirox Olamine is classified as Skin Corr. 1B, H314 according to Regulation (EC) n. 1272/2008 (CLP), because of ethanolaminium cation.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key 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 skin corrosion/irritation studies for 2-aminoethanol, neutral form of ethanolaminium cation.

GLP compliance:

not specified

Remarks:

Data published. No detailed information about GLP compliance.

Species:

other: laboratory animals

Irritation parameter:

overall irritation score

Remarks on result:

other: corrosive to the skin

Interpretation of results:

Category 1B (corrosive) based on GHS criteria

Conclusions:

2 -aminoethanol (MEA), the neutral form of ethanolminium cation, is considered corrosive to skin.

Reference 2

Endpoint:

skin irritation / corrosion, other

Remarks:

(Q)SAR

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 and falling into its applicability domain, with limited documentation / justification

Justification for type of information:

see attached "Report CAS 29342-05-0"

Principles of method if other than guideline:

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

Interpretation of results:

GHS criteria not met

Conclusions:

6-cyclohexyl-4-methyl-2-oxopyridin-2(1H)-olate anion is considered as not skin irritant, according to the available QSAR data on its neutral form, Ciclopirox.

Reference 3

Endpoint:

skin irritation: in vivo

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

Irritation parameter:

overall irritation score

Remarks on result:

no indication of irritation

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

Conclusions:

Human data on a product containing 0.77% of ciclopirox olamine confirms that the substance at this concentration is not irritant.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key 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 irritating potential for 2-aminoethanol, neutral form of ethanolaminium cation.

GLP compliance:

not specified

Remarks:

Data published. No detailed information about GLP compliance.

Species:

other: laboratory animals

Irritation parameter:

overall irritation score

Remarks on result:

other: corrosive or causes severe eye irritation

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

2 -aminoethanol (MEA) , the neutral form of ethanolminium cation, is considered as corrosive to eyes.

Reference 2

Endpoint:

eye irritation, 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 and falling into its applicability domain, with limited documentation / justification

Justification for type of information:

see attached "Report CAS 29342-05-0"

Principles of method if other than guideline:

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

Interpretation of results:

GHS criteria not met

Conclusions:

6-cyclohexyl-4-methyl-2-oxopyridin-2(1H)-olate anion is considered as not eye irritant, according to the available QSAR data on its neutral form, Ciclopirox.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available