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
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