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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:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable publication which meets basic scientific principles.

Data source

Reference
Reference Type:
publication
Title:
e-Caprolactam
Author:
Goldblatt M.W. et al.
Year:
1954
Bibliographic source:
Brit. J. Ind. Med. 11, 1-10

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Patch test with 6 volunteers was performed using 5% solution of the test substance.

Test material

Constituent 1
Chemical structure
Reference substance name:
ε-caprolactam
EC Number:
203-313-2
EC Name:
ε-caprolactam
Cas Number:
105-60-2
Molecular formula:
C6H11NO
IUPAC Name:
azepan-2-one

Method

Type of population:
general
Subjects:
- Number of subjects exposed: 6
- Sex: 4 males and 2 females
- Race: one fair girl, one dark girl, two fair men, two dark men
Details on study design:
TYPE OF TEST(S) USED: patch test


ADMINISTRATION
- Vehicle / solvent: water
- Concentrations: 5 %
- Removal of test substance: after 48 h

Results and discussion

Any other information on results incl. tables

No irritant effects of any kind were produced. Similar experiments were carried out with a 5% olive oil solution of the test substance, and again it was found with five subjects that no irritant effects were produced during four days of application twice a day.

Applicant's summary and conclusion

Conclusions:
No irritant effects of any kind were produced.
Executive summary:

A Patch test with 6 volunteers was performed using 5% solution of the test substance. 5% aqueous test substance to the skin of the inner forearms of six normal persons as a 4 cm x 3 cm patch test left in contact for 48 hours. There were no reactions produced by the test substance. In a second series of tests, a 5% alcoholic solution of the test substance was applied by placing six drops on the same area: the alcohol was allowed to evaporate and the residue kept undisturbed in contact with the skin throughout the day. The process was repeated twice daily for four days. No irritant effects of any kind were produced. Similar experiments were carried out with a 5% olive oil solution of the test substance, and again it was found with five subjects that no irritant effects were produced during four days of application twice a day.