Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Cross-reference
Reason / purpose:
data waiving: supporting information
Reference

The vapour pressure of the test substance was determined experimentally using the isoteniscope method, according to OECD Guideline 104 and EU Method A.4, (Chilworth, 2017) as well using QSAR models of EPI Suite and US EPA T.E.S.T. (US EPA, 2018).

Vapour pressure:
0 Pa
at the temperature of:
25 °C

- Experimental VP = <100 Pa at 20 °C (using isoteniscope method); not a suitable method for multi-constituents or UVCBs.

- Weighted average QSAR based VP = 0.00000187 Pa at 25°C (using EPI Suite v.4.11) and 0.000249 Pa at 25°C ( US EPA T.E.S.T. v4.2.1). The estimates for the major constituents are considered to be reliable with restrictions, as they do not completely fall within of the applicability domain.

- Experimental VP of structurally similar substance, C8-18 and C18-unsatd. DEA: 1.39 x 10-4 Pa at 20°C and 2.91 x 10-4 Pa at 25°C, respectively (ECHA REACH dossier; EC: 931-329-6).

Overall, based on the above information, the test substance can be considered to have low volatility potential. However, in absence of a specific value from the experimental study, and given that isoteniscope method is not a suitable method for determining VP values for multi-constituent or UVCB substances, the higher QSAR based VP value (i.e., 0.000249 Pa) has been considered further for hazard/risk assessment.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion