Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
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
Propylene dinonanoate (CAS 41395-83-9) has a very low calculated vapour pressure of 1.4E-005 Pa at 20 °C thus being of low volatility. Under normal use and handling conditions, inhalation exposure and the availability for respiratory absorption of the substance in the form of vapours, gases, or mists is considered to be limited (ECHA, 2017).
Based on the physical state and the physico-chemical properties of propylene dinonanoate (CAS 41395-83-9), absorption via the lung is expected to be of no toxicological concern.

Propylene dinonanoate (also named propylene glycol dipelargonate) was reported to be used at the highest concentration, 60%, in perfumes and at lower concentrations in hair preparations (CIR 2014). The cosmetic ingredient review panel stated that in practice, 95% to 99% of the droplets/particles released from cosmetic sprays have aerodynamic equivalent diameters >10 μm. Therefore, most droplets/particles incidentally inhaled from cosmetic sprays would be deposited in the nasopharyngeal and bronchial regions and would not be respirable (ie, they would not enter the lungs) to any appreciable amount (CIR, Cosmetic Ingredient Review Expert Panel (2014): Safety Assessment of Propylene Glycol Esters as Used in Cosmetics).

Data source

Materials and methods

Test material

Constituent 1
Chemical structure
Reference substance name:
Propylene dinonanoate
EC Number:
255-350-9
EC Name:
Propylene dinonanoate
Cas Number:
41395-83-9
Molecular formula:
C21H40O4
IUPAC Name:
1-(nonanoyloxy)propan-2-yl nonanoate

Results and discussion

Applicant's summary and conclusion