Registration Dossier

Diss Factsheets

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:
The substance has low vapour pressure
Although supplied in water and used in liquid form, there is a low risk of aerosol formation during normal use as a corrosion inhibitor in closed systems.
Cross-reference
Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Endpoint:
vapour pressure
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Although done to a recognised screening test method, the nature of this UVCB substance means that only the the most volatile constuent will have been measured; in the case of this reaction product, it is likely that unreacted starting materials may contribute to the findings.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 104 (Vapour Pressure Curve)
Version / remarks:
Dynamic method
GLP compliance:
no
Type of method:
effusion method: isothermal thermogravimetry
Test no.:
#1
Temp.:
ca. 20 °C
Vapour pressure:
ca. 644 Pa

Use of ebulliometer, with the temperature stabilised at 107 C. Calculated back for 20 C

Conclusions:
Although done to a recognised screening test method, the nature of this UVCB substance means that only the the most volatile constuent will have been measured; in the case of this reaction product, it is likely that low molecular weight components will contribute to the findings. However, the smallest identified component has an estimated vapour pressure of < 10 Pa.

Although it was attempted to remove water, the 'dried' sample will have residual residual water and this is th emost likely reason for the higher than expected vapour pressure.

A very large proportion of the components have molecular weights in excess of 200 and a review of vapour pressure data suggests < 0.1 Pa can be expected; however, the same modelling and assessment suggest that the product should be solid (this makes the presence of significant levels of water or liquid amines acting as solvent).

A figure of 644 Pa is considered high for the CSR and a more conservative figure of 1 Pa is used.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion