Registration Dossier
Registration Dossier
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EC number: 203-702-7 | CAS number: 109-76-2
Sensitisation data (human)
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:
- 1 982
- 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 substance name:
- Ethylenediamine
- EC Number:
- 203-468-6
- EC Name:
- Ethylenediamine
- Cas Number:
- 107-15-3
- Molecular formula:
- C2H8N2
- IUPAC Name:
- ethane-1,2-diamine
- Details on test material:
- Also piperazine was tested.
Constituent 1
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.
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