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EC number: 203-468-6 | CAS number: 107-15-3
Skin responses were evaluated and scored. 45% of animals tested showed signs of sensitisation.
In a Guinea Pig Maximisation test ethylene diamine was a sensitiser. Cross sensitisation with other ethylene amine substances was observed.
Based on the available Guinea Pig Maximisation study, with an intradermal induction of 5%, and based on moderate effects in humans a category of 1B is justified.
In 1999 the World Health Organization published their Concise International Chemical assessment Document 15 on 1,2 –Diaminoethane (ethylenediamine). This document referenced several case reports of respiratory senitisation apparently due to exposure to ethylene daimine but the incidence was not specified other than in one report when it was quoted to be 10%. This was a retrospective study so no challenge tests were done. Aldrich, FD, Strange AW and Geesman RE published in 1987 Smoking and ethylenediamine sensization in an industrial population, J. Occup Med 1987 Apr; 29(4) 311-314., from the abstract the incidence they was 38 out of 337 workers ca. 11%.
The paper by Lars Hagmar, MD et.al, Piperazine induced Occupational Asthma, Journal of occupational Medicine, Vol 24 No 3. March 1982, mention 2 individuals sensitized in a population of 130 workers, who had been exposed to ethylenediamine which was used until the previous year i.e. ca, 3% incidence.
In a large review paper authored by M. Chan-Yeung and J-L. Malo, Aetiological agents in occupational asthma in the Eur Resp J 194, 7 , 346-371, they reviewed about 200 agents implicated in occupational asthma. While they only included some case reports for ethylene diamine they did give percentage incidence values for some known strong respiratory sensitisers such as the diisocyanates, including TDI and HDI and some anhydrides. For these the percentage incidences were in the order of 28-35%. As we would expect these substances to be classified as 1A for respiratory sensitization we see this level of incidence being necessary to support a conclusion of high frequency. Based on this we would interpret the incidence of ca. 3-11% seen with ethylene diamine as being in the low to moderate frequency range and therefore supporting a classification of 1B. None of the admittedly limited available information supports a conclusion of 1A.
So we recommend that ethylenediamine be classified as 1B for respiratory sernsitisation based on the above information.
Ethylene diamine is classified as a skin and respiratory sensitiser.
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