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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1975
Report date:
1975
Reference Type:
secondary source
Title:
Unnamed
Year:
1987
Reference Type:
secondary source
Title:
Unnamed
Year:
1991

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
Schwartz-Peck Prophetic Patch test to determine the irritation, sensitisation, and phototoxicity of a lotion product containing 1.1 % TIPA. The lotion was applied in covered or uncovered contact for 48 hr in 98 volunteers, followed by covered or uncovered 48-hr challenge test after a 14-day rest period.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1,1',1''-nitrilotripropan-2-ol
EC Number:
204-528-4
EC Name:
1,1',1''-nitrilotripropan-2-ol
Cas Number:
122-20-3
Molecular formula:
C9H21NO3
IUPAC Name:
1-[bis(2-hydroxypropyl)amino]propan-2-ol
Specific details on test material used for the study:
lotion containing 1.1% 1,1',1''-nitrilotripropan-2-ol
Lotion: CFDS-12-49

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
Ninety eight panelists
Clinical history:
no data
Controls:
no data
Route of administration:
dermal
Details on study design:
Ninety-eight panelists participated in a Schwartz-Peck Prophetic Patch test to determine the irritation, sensitisation, and phototoxicity of a lotion product containing 1.1 % TIPA. Open and occlusive patches were applied for 48 h, and results were scored according to the International Contact Dermatitis Research Group procedure with a 0-3+ scoring scale. After a nontreatment period of approximately 14 days, a second set of open and occlusive patches was applied and scored 48 h later. After scoring the second occlusive patch reactions, these same test sites of all panelists were irradiated for 1 minute with a Hanovia Tanette Mark I Lamp (wavelength 5600 Angstroms). This site was scored for phototoxicity 48 h later.

Results and discussion

Results of examinations:
No reactions were observed at the first or second open patch, the first occlusive patch, or 48 h after irradiation. Four subjects had 1+ (weak, nonvesicular) reactions to the second occlusive patch, and one subject had a 2+ (strong, edematous or vesicular) reaction to the second occlusive patch. These reactions were not considered clinically significant. The product was not an irritant, phototoxin, or sensitiser under these test condition.

Any other information on results incl. tables

Ninety-three subjects were negative (-), four subjects were a weak 1+ (0-3+ scale) and one subject was observed with a strong, 2+ reaction to the 2nd closed patch. No reactions at open and irradiated sites. Not an irritant, sensitizer, or phototoxin.

Applicant's summary and conclusion