1-hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)pyridin-2(1H)-one, compound with 2-aminoethanol (1:1)

Specific investigations: other studies

Administrative data

Endpoint:

specific investigations: other studies

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Phototoxicty study in human volunteers following GCP principles

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

Topical application of the test substance to the healthy skin of volunteers and subsequent ray treatment with UV-A and UV-B. Irradiation of untreatedskin sites as control.

GLP compliance:

no

Remarks:

study followed GCP

Type of method:

other: human volunteer study

Endpoint addressed:

skin irritation / corrosion

skin sensitisation

Test material

Test material information

Constituent 1

Reference substance name:

Octopirox

IUPAC Name:

Octopirox

Constituent 2

Reference substance name:

1-hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)pyridin-2(1H)-one, compound with 2-aminoethanol (1:1)

EC Number:

272-574-2

EC Name:

1-hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)pyridin-2(1H)-one, compound with 2-aminoethanol (1:1)

Cas Number:

68890-66-4

Molecular formula:

C14H23NO2.C2H7NO

IUPAC Name:

1-hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)pyridin-2(1H)-one, compound with 2-aminoethanol (1:1)

Constituent 3

Reference substance name:

1-hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)-2-pyridinone, 2-aminoethanol salt

IUPAC Name:

1-hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)-2-pyridinone, 2-aminoethanol salt

Test animals

Species:

human

Sex:

male/female

Administration / exposure

Route of administration:

dermal

Vehicle:

other: isopropanol - water (1:1)

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

Test substance preparation was applied for 1 hour followed by irradiation with UV A or UV B

Frequency of treatment:

Single treatment

Examinations

Examinations:

Examination of skin status following irradiation regarding indications for irritation, sensitization or any other dermal changes

Results and discussion

Details on results:

The clinical observations did not reveal any indication of phototoxic properties induced by Octopirox.

Applicant's summary and conclusion

Conclusions:

Based on the test results Octopirox exhibited no indications of phototoxic properties in humans.

Executive summary:

Possible phototoxic properties of piroctone olamine were evaluated in 7 healthy volunteers using a 0.1 % solution of piroctone olamine in water / isopropanol (1:1 v/v). The test solution was applied to the skin of the test persons one hour prior to ray treatment with a UV-B photo lamp. In a further experiment, ray treatment was performed in the UV-A range. No indications of phototoxic properties of piroctone olamine were noticed either in the UV-B or the UV-A range.