Fatty acids, C16-18 and C18-unsatd., reaction products with triethanolamine, di-Me sulfate-quaternized

Exposure related observations in humans: other data

Administrative data

Endpoint:

exposure-related observations in humans: other data

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Test procedure according to standard method

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Type of study / information:

The test substance was investigated for skin irritation in 20 healthy volunteers in an 24 hour occlusive patch test at a concentration of 1 % active
substance.

Endpoint addressed:

skin irritation / corrosion

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Duhring-Kammer-Test method

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C16-18 (even numbered) and C18 unsatd., reaction products with triethanolamine, di-Me sulfate-quaternized

EC Number:

931-203-0

Cas Number:

1335202-88-4

Molecular formula:

Not applicable, the subtance is UVCB

IUPAC Name:

Fatty acids, C16-18 (even numbered) and C18 unsatd., reaction products with triethanolamine, di-Me sulfate-quaternized

Method

Details on study design:

The Duhring-Kammer-Test is an occlusive, epicutaneous test system, to determin skin irritation in human volunteers.
Scoring was performed according to the method of Kligman and Frosch (Contact Dermatitis 5, 1979, 73 - 81)

The test substance was investigated with the Duhring Kammer Test method according to the publication of Kligman and Frosch (Contact Dermatitis 5, 1979, 73 -81) for skin irritation in 20 healthy volunteers in a 24 hour occlusive patch test at a concentration of 1 % active substance.
70 µL of the test substance was applied via large finn chambers (12 mm Ø) on scanpor plaster to the back of the volunteers. Irritating effects were scored 6, 24, 48 and 72 hours after removal of patches.
Reference substances were aqua demin., phys. NaCl, cosmetic alcohol, SDS 0.5 % a.i. and Texapone N25 1.0 % a.i.

Details on exposure:

TYPE OF EXPOSURE: Large Finn Chambers (diameter 12 mm) on Scanpor plaster were placed on the back of the panalists.
EXPOSURE LEVELS: 10 % a.i.; 70 µL/ patch
EXPOSURE PERIOD: 24 hours
POSTEXPOSURE PERIOD: Scoring after 6, 24, 48 and 72 hours
DESCRIPTION / DELINEATION OF EXPOSURE GROUPS / CATEGORIES: 20 healthy male and female volunteers (aged 20 to 56 years)

Results and discussion

Results:

In none of the 20 panelists a positive reaction for erythema, oedema, scaling or fissuring was observed for the test substance.

Applicant's summary and conclusion

Conclusions:

There is no evidence for a skin irritating effect of the partially unsaturated TEA-Esterquat in this study.

Executive summary:

The skin irritating potential of the test substance “partially unsaturated TEA-Esterquat” was investigated with the Duhring Kammer Test method according to the publication of Kligman and Frosch (Contact Dermatitis 5, 1979, 73 -81) in 20 healthy volunteers in a 24 hour occlusive patch test at a concentration of 1 % active substance.

70 µL of the test substance was applied via large finn chambers (12 mmØ) on scanpor plaster to the back of the volunteers. Irritating effects were scored 6, 24, 48 and 72 hours after removal of patches. Reference substances were aqua demin., phys. NaCl, cosmetic alcohol, SDS 0.5 % a.i. and Texapone N25 1.0 % a.i.

In none of the 20 panelists a positive reaction for erythema, oedema, scaling or fissuring was observed for the test substance.