Registration Dossier

Toxicological information

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:
other information
Study period:
1976
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:
1976
Report Date:
1976
Reference Type:
secondary source
Title:
Unnamed
Year:
1976

Materials and methods

Type of study / information:
Dermal irritation study with human volunteers
Endpoint addressed:
skin irritation / corrosion
Principles of method if other than guideline:
The irritancy of a prototype lotion product containing 1.1% TIPA was evaluated in a 21-day cumulative irritation test using 10 panelists.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Lotion containing 1.1% 1,1',1''-nitrilotripropan-2-ol

Method

Ethical approval:
not specified
Details on study design:
The irritancy of a prototype lotion product containing 1.1% TlPA was evaluated in a 21-day cumulative irritation test using 10 panelists. Occlusive patches containing 0.3 ml lotion were applied to the upper back of each panelist, and panelists were instructed to remove the patch in 23 h, bathe or shower, then present themselves at the clinic for test site scoring and reapplication of the next patch. Patches were applied for 21 consecutive days.
Exposure assessment:
not specified

Results and discussion

Results:
One panelist had no reactions throughout the study. Nine of the 10 panelists had three or more grade 1 (max 7), minimal erythematous reactions, 5/9 had one or more grade 2, definitely erythematous reactions, and 1/9 had three reactions accompanied by glazing with peeling and cracking of the skin. The group total cumulative irritation score was 89 (max 630). The prototype lotion was a slight skin irritant.

Applicant's summary and conclusion