Registration Dossier

Toxicological information

Health surveillance data

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Administrative data

Endpoint:
health surveillance data
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

Referenceopen allclose all

Reference Type:
publication
Title:
Caprolactam Vapor Exposures.
Author:
Ferguson, W.S. & Wheeler, D.D.
Year:
1973
Bibliographic source:
Am. Ind. Hyg. Ass. J. 34, 384-389.
Reference Type:
publication
Title:
Caprolactam Vapor Exposures.
Author:
Ferguson, W.S. & Wheeler, D.D.
Year:
1973
Bibliographic source:
Cited in: Henschler, D. (Hrsg.), Gesund- heitsschaedliche Arbeitsstoffe. Toxikologisch-arbeitsmedizinische Begruendung von MAK-Werten: Caprolactam (Nachtrag 1990), 1.-17. Lfg., Verlag Chemie (1991).

Materials and methods

Study type:
health record from industry
Remarks:
for over 18 years period at Chesterfield, US
Endpoint addressed:
respiratory irritation
Test guideline
Qualifier:
no guideline available

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
Specific details on test material used for the study:
- Name of test material (as cited in study report): Caprolactam

Method

Type of population:
occupational
Details on study design:
The test substance concentrations at the workplace were not specified.

Results and discussion

Any other information on results incl. tables

No differences in general health were noted in occupational groups exposed to the test substance vapor versus unexposed employees. Over the l8-year period, no employee was removed from exposure to the test substance vapor for health reasons; no employee was removed for reasons of health or discomfort. Over 18 years, there were three cases of skin irritation serious enough to require medical follow-up. All were due to direct contact with the test substance or its highly concentrated solutions.

Applicant's summary and conclusion

Conclusions:
No differences in general health were noted in occupational groups exposed to the test substance vapor versus unexposed employees.
Executive summary:

A Retrospective evaluation of the medical records from a period of 18 years for 143 workers exposed in the USA was performed. No differences in general health were noted in occupational groups exposed to the test substance vapor versus unexposed employees. Over the l8-year period, no employee was removed from exposure to the test substance vapor for health reasons; no employee was removed for reasons of health or discomfort. Over 18 years, there were three cases of skin irritation serious enough to require medical follow-up. All were due to direct contact with the test substance or its highly concentrated solutions.