Registration Dossier
Registration Dossier
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EC number: 204-826-4 | CAS number: 127-19-5
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:
- test procedure in accordance with national standard methods with acceptable restrictions
- Remarks:
- lack of details
Data source
Reference
- Reference Type:
- publication
- Title:
- HUMAN PATCH TEST OF 19 SUBJECTS WITH NOMEX E-23 WITH 3.7% DMAC, WITH COVER LETTER DATED 9/29/95 (SANITIZED)
- Author:
- DuPont Specialty Chemicals, Wilmington
- Year:
- 1 995
- Bibliographic source:
- TSCA8(d), OTS0558317
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- Human patch test
Test material
- Reference substance name:
- N,N-dimethylacetamide
- EC Number:
- 204-826-4
- EC Name:
- N,N-dimethylacetamide
- Cas Number:
- 127-19-5
- Molecular formula:
- C4H9NO
- IUPAC Name:
- N,N-dimethylacetamide
- Details on test material:
- no details
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- Test material with 3.7% DMAC
Method
- Type of population:
- not specified
- Ethical approval:
- not specified
- Subjects:
- 13 men and 6 women
- Route of administration:
- dermal
- Details on study design:
- Fiber tufts of the test material (with 3.7% DMAC) covering approximately one square inch were applied to the arms of 13 men and to the arms or legs of 6 women and held in place with adhesive tape for six days. After a two-week rest period new patches were applied for two days as a challenge test for skin sensitization. Skin under the patches wwa sexamined at two and six days after the initial application and on removal of the challenge patch.
Results and discussion
- Results of examinations:
- 2-Day Observation: No reactions.
6-Day Observation:
Subject A** - Slight erythema with diffuse rash. One hour later - no reactions, rash persisted. At 24 hours - few small papules.
Subject B - Few small papules.
2-Day (Challenge) Observation: No reactions.
**Subject bad perspired profusely under patch. At one hour, entire area coverad by adhesive appeared dry and scaly.
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
