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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:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1964

Materials and methods

Type of sensitisation studied:
skin
Study type:
other: patch test
GLP compliance:
no

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.

Method

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

EXAMINATIONS
- 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

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