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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Reliable survey Trimethylenediamine is structurally very similar to the test substance ethylenediamine (difference: chain length / one CH2-group). Thus, the test result is justified for read across with respect to trimethylenediamine.

Data source

Reference
Reference Type:
publication
Title:
Piperazine-induced occupational asthma
Author:
Hagmar, L., et al
Year:
1982
Bibliographic source:
Journal of Occupational Medicine, Vol. 24, No 3

Materials and methods

Type of sensitisation studied:
respiratory
Study type:
survey
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Survey of workers in a chemical factory.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Also piperazine was tested.

Method

Type of population:
occupational
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 130
- Sex: 129 male, 1 female

Route of administration:
inhalation

Results and discussion

Results of examinations:
Occupational asthma, diagnosed as recurrent dyspnoea with wheezing breathing and coughing, in association with exposure to agent. The agent was judged to be piperazine in 29 persons and ethylene diamine in 3 persons.

Any other information on results incl. tables

Eleven persons presently employed were asthmatic or had experienced asthma associated with exposure to chemicals. In 13 former employees medical reports supported the diagnosis of occupational asthma associated with chemicals. The criteria for diagnosis was recurrent dyspnoea with wheezing breathing and coughing, in association with exposure to agent. The agent was judged to be piperazine in 29 persons and ethylene diamine in 3 persons.

Applicant's summary and conclusion

Conclusions:
Ethylene diamine is a respiratory sensitiser in humans. Trimethylenediamine is structurally very similar to the test substance ethylenediamine and therefore the test result is justified for read across.