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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Human volunteer study according to GCP
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Human epicutaneous patch test
GLP compliance:
no
Remarks:
followed GCP

Test material

Constituent 1
Reference substance name:
Octopirox
IUPAC Name:
Octopirox
Constituent 2
Reference substance name:
Piroctone Olamine
IUPAC Name:
Piroctone Olamine
Constituent 3
Chemical structure
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 4
Reference substance name:
1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)-2-pyridone, 2-aminoethanol salt
IUPAC Name:
1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)-2-pyridone, 2-aminoethanol salt
Details on test material:
Test product: Surfactant formulation SI 76 / 4

Method

Ethical approval:
confirmed, but no further information available
Subjects:
- Number of subjects exposed: 50 (including 19 allergic subjects and subjects with sensitive skin)
- Sex: male (19) / female (31)
- Age: 16 - 64
Clinical history:
Medical history and diagnosis available
Controls:
No
Route of administration:
dermal
Details on study design:
Patch test (epicutaneous test) using a commercial test plaster. The test plaster was placed on the clinically healthy skin of 50 human volunteers. Plaster was held in contact for 48 hours. readings performed at 48 h and 72 h.

Results and discussion

Results of examinations:

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions 50
- Number of subjects with equivocal reactions 0
- Number of subjects with irritating reactions 0

Applicant's summary and conclusion

Conclusions:
The test formulation gave no indication that the product has a primary irritant effect on the skin. Also, in this test no sensitisation potential already present was triggered by the ingredients including piroctone olamine.
Executive summary:

A group of 50 female and male volunteers aged between 16 and 64 years took part in the study. Using a commercial test plaster, the test substance was placed on the clinically healthy skin and secured. The test plaster was removed after 48 hours and the test sites assessed. Further assessments were made after 72 hours. No positive or dubious skin reactions were observed after either 48 h or 72 h, so this test gave no indication that the product has a primary irritant effect on the skin. Also, in this test no sensitisation possible present was triggered by any of the ingredients of the product, including piroctone olamine.