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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
other information
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented study

Data source

Reference Type:

Materials and methods

Type of sensitisation studied:
Study type:
other: patch test
GLP compliance:

Test material

Constituent 1
Details on test material:
- Physical state: liquid
- Purity: 50%
Beside the TS 36 othe substances used in finishing textiles were tested.


Type of population:
- Number of subjects exposed: 66
Clinical history:
Suspected of suffering from a textile finish contact eczema.
Route of administration:
Details on study design:
TYPE OF TEST(S) USED: patch test

- Grading/Scoring system: - (negative) up to ++++ (red application sites with papules and vesicles, oozing or enlarged)

Results and discussion

Results of examinations:
In 27 of 66 patients positive patch-test reactions to various textile finishes and additives were observed after 48 hours contact. DMDHEU caused following reactions: 3 patients with red application sites with papules and vesicles; 3 patients with red application sites with papules or swelling, 1 patient with red application site, 1 patient with slightly red application site; 16 patients without positive reactions; 3 patients were not tested for DMDHEU reactions. 6 out of the 8 positive patients were also positive for formaldehyde.
In 39 patients suspected of having textile contact eczema, only negative patch-test reactions were obtained.
This may have been due to a wrongly interpreted anamnesis or clinical picture, or to the incompleteness of our test series of substances, because in a small number of cases these patients reacted positively to patchtested textiles.

Applicant's summary and conclusion