Registration Dossier
Registration Dossier
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EC number: 296-664-6 | CAS number: 92908-35-5
Sensitisation data (human)
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:
- 1 964
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- other: patch test
- GLP compliance:
- no
Test material
- Details on test material:
- - Physical state: liquid
- Purity: 50%
Beside the TS 36 othe substances used in finishing textiles were tested.
Constituent 1
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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