Prop-2-yn-1-yl 1H-imidazole-1-carboxylate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Data waiving:

other justification

Justification for data waiving:

the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
The standard information required for all substances manufactured or imported in quantities of 10-100 tonnes in accordance with Article 12(1)(c).
1. Column 2 under EU REACH regulation Annex Ⅷ, section 8.5, In addition to the oral route (8.5.1.) or to the inhalation route (8.5.2) for nanoforms, for substances other than gases, the information mentioned under 8.5.1. to 8.5.3. shall be provided for at least one other route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. If there is only one route of exposure, information for only that route needs to be provided.
2. According to the results of Lead Registrant (8.5.1. By oral route), the LD50 of the test item 2-propyn-1-y1 1H-imidazole-1-carboxylate is greater than 50 mg/kg and lower than 300 mg/kg body weight after single oral administration to Wistar rats.
Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD Guideline 423 it can be concluded that the test item 2-propyn-1-y1 1H-imidazole-1-carboxylate is classified GHS Category 3 with a LD50 cut off value 200 mg/kg body weight, after single oral administration to Wistar rats. Lead Registrant has completed the Acute Oral toxicity study (OECD Guideline 423). We have purchased the LOA.
We have also completed Acute Dermal Toxicity study (OECD Guideline 402, EU REACH Annex VIII 8.5.3. By dermal route) for the second route and submit the data in this dossier.
3. According to the results of Lead Registrant’s dossier, the particle size key result: D95 >= 100 µm (ISO 2926:2013), we have purchased the LOA. Particles larger than 100 μm are less likely to be inhalable. Base on the nature of the substance and the likely route of human exposure, the choice for the second route is dermal route.
Conclusions
Regarding the endpoint 8.5.2. By inhalation, the registered substance Prop-2-yn-1-yl 1H-imidazole-1-carboxylate (EC 695-595-2) could meet the Column 2 waving condition and thus this endpoint is study scientifically not necessary.