Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
short-term repeated dose toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
data waiving: supporting information
Reference

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

Vapour pressure:
4 Pa
at the temperature of:
20 °C

- Experimental VP = 4 Pa at 20 °C (using static method); study suspected to be influenced by trapped gas/impurities.

- Weighted average QSAR based VP = 2.16E-5 Pa at 25°C (using EPI Suite v.4.11). The estimates for the major constituents are considered to be reliable with restrictions, as they do not completely fall within of the applicability domain.

Overall, based on the above information, the test substance can be considered to have low volatility potential. However, the higher VP value of 4 Pa has been considered further for hazard/risk assessment as a conservative approach.

Reason / purpose for cross-reference:
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 block)

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion

Categories Display