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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Acute toxicity, oral, rats: LD50 > 3200 mg/kg bw.
Acute toxicity, dermal, rats: LD50 > 2500 mg/kg bw.
Acute toxicity, inhalation, rats: saturated vapours of the test material were survived for 8 hours.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
3 200 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Dose descriptor:
LC50
Value:
16 000 mg/m³ air

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 500 mg/kg bw

Additional information

Inhalation toxicity:

 

No mortality was noted in rats when exposed to "saturated vapour" of DEM for 8 hours.

According to DSM, the saturated vapour concentration of DEM is 1 mg/L.

 

Given the respiratory volume for rats of 0.2 L/min for a 250 g rat (REACH Guidance on Information Requirement No. 8), ca. 200 L are inhaled by 1 kg rat in 4 hours. For saturated vapour of DEM this corresponds to 200 mg/kg in 4 hours (and 400 mg/kg in 8 hours).

 

The LD50(acute,oral,rats) was determined with > 3200 mg/kg bw. Applying a default value of 2 for the possible differences in absorption between the oral and the inhalation route, in accordance with the REACH Guidance on Information Requirement No. 8, this corresponds to an LC50(acute,oral,rats) of >1600 mg/kg bw.

200 and even 400 mg of saturated vapour of DEM per kg bw is therefore well below this dose level.

 

If DEM would be administered as an aerosol, the highest level according to the acute inhalation toxicity protocol (Reg 440/2008) is 5 mg/L. With regard to the respiratory volume of rats (200 L/kg bw/4 hours) 1 g of DEM aerosol per kg body weight would be inhaled in a 4 hours acute inhalation toxicity study. This is also well below the LC50 >1600 mg/kg bw derived from acute oral toxicity data.

Justification for classification or non-classification

From the data available no classification can be derived.