Registration Dossier
Registration Dossier
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EC number: 212-828-1 | CAS number: 872-50-4
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
Data source
Referenceopen allclose all
- Reference Type:
- secondary source
- Title:
- Toxicity of N-methyl-2-pyrrolidone (NMP): teratogenic, subchronic, and two-year inhalation studies
- Author:
- Lee KP et al.
- Year:
- 1 987
- Bibliographic source:
- Fundam Appl Toxicol 9: 222-235
- Reference Type:
- secondary source
- Title:
- Concise International Chemical Assessment Document (CICAD) 35, N-Methyl-2-2-Pyrrolidone
- Author:
- WHO, Geneva, Switzerland
- Year:
- 2 001
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 1-methyl-2-pyrrolidone
- EC Number:
- 212-828-1
- EC Name:
- 1-methyl-2-pyrrolidone
- Cas Number:
- 872-50-4
- Molecular formula:
- C5H9NO
- IUPAC Name:
- 1-methylpyrrolidin-2-one
- Test material form:
- liquid
Constituent 1
Method
- Type of population:
- not specified
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 50
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: repeated insult patch test (epicutaneous test)
ADMINISTRATION
- No. of applications: 15
- exposure time: 24 hours
- Removal of test substance: not indicated
Results and discussion
- Results of examinations:
- NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: none
- Number of subjects with negative reactions: all 50 subjects
- Number of subjects with irritating reactions: none
Any other information on results incl. tables
A total of 15 24-h exposures in a repeated-insult patch test in human subjects (n = 50) caused minor to moderate transient irritations. No signs of contact sensitization were observed. The information from this secondary literature source suggests that NMP is not a human skin sensitizer.
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.
