Registration Dossier

Toxicological information

Direct observations: clinical cases, poisoning incidents and other

Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1930
Report date:
1930

Materials and methods

Study type:
study with volunteers
Endpoint addressed:
skin irritation / corrosion
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Patch test
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Reference substance 001
Details on test material:
- Name of test material (as cited in study report): Triethanolamine
- no further details

Method

Type of population:
general
Ethical approval:
not specified
Route of exposure:
dermal
Reason of exposure:
intentional
Details on exposure:
A patch of about 2 cm² in size was soaked with the liquid test materail and was applied to the upper arm of 6 volunteers, fixed by an adhesive tape. The patch was removed 24 hours later and skin irritation was assessed immediately upon patch removal and 24 hours later.

Results and discussion

Clinical signs:
1 one case slight biting upon patch application combined with slight reddening was reported by one volunteer. No further clinical signs reported.
Results of examinations:
Upon patch removal no signs of skin irritation were apparent throughout the 6 volunteers. No further data reported.

Applicant's summary and conclusion