ε-caprolactam

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:

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

Test material information

Constituent 1

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.