Registration Dossier

Administrative data

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

The physical state and appearance of the test substance were observed during the testing of other endpoints (Chilworth, 2017).

Physical state at 20°C and 1013 hPa:
solid

(white solid pellets)

Reason / purpose:
data waiving: supporting information
Reference

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

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

- Experimental VP: 277 Pa (using static method); the VP value is suspected to be influenced by trapped gases/impurities.

- Weighted average QSAR based VP: 0.00072 Pa at 25°C (using EPI Suite v.4.11) and 0.0021 Pa at 25°C (using 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.

- VP values for the main constituents, phosphate esters (PSE), alcohol and isoalkyl esters: 0.00289 Pa at 20°C (using effusion method) for mono- and di- C16 PSE, K+ (ECHA REACH dossier on CAS 19035-79-1); 0.0014-0.0016 Pa at 25˚C for hexadecane-1-ol (OECD SIDS, 2006); 9.79E-12 at 20 °C (Estimated using SPARC v.4.6) for isostearyl isostearate (ECHA REACH dossier on CAS:41669-30-1) respectively.

 

Overall, based on the above information, the test substance can be considered to have low volatility potential. In absence of a reliable experimental value for the overall test substance, the relatively higher QSAR based VP value of 0.0021 Pa has been considered further for hazard/risk assessment as a conservative approach.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion