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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:
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:
1987
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:
2001

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
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

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.

 

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