Registration Dossier
Registration Dossier
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EC number: 485-350-6 | CAS number: 405095-33-2
Vapour pressure
Administrative data
Link to relevant study record(s)
- Endpoint:
- vapour pressure
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP Guideline study; documentation sufficient for assessment. As a deviation from the OECD guideline resp. the EEC guideline and in accordance with the US guideline 40 CFR 158.120 section 63 -9, only the determination of the vapour pressure at 25°C was done.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 104 (Vapour Pressure Curve)
- Deviations:
- yes
- Remarks:
- see remarks field results
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.4 (Vapour Pressure)
- Deviations:
- yes
- Remarks:
- see remarks field results
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- This study has been performed in compliance with Good Laboratory Practice (GLP) in Switzerland, Procedures and Principles, March 1986, issued by the Federal Department of the Interior and the Intercantonal Office for the Control of Medicaments, Switzerlan
- Type of method:
- gas saturation method
- Key result
- Test no.:
- #1
- Temp.:
- ca. 25 °C
- Vapour pressure:
- ca. 0 Pa
- Conclusions:
- The vapour pressure at 25°C of Phenylguanidine is 1.7x10-5 Pa.
- Executive summary:
The study was carried out according to GLP rules.
The study was conducted according to OECD Guideline 104 and Guideline EEC/84/449 A.4. The vapour pressure was measured to be 1.7x10-5 Pa with the gas saturation method.
Reference
Temperature (°C) |
Nitrogen |
Duration of experiment (h) |
Amount of substance (µg) |
Vapour pressure (Pa) |
|
Flow rate (ln/h) |
Volume (ln) |
||||
25.04 |
7.35 |
705.60 |
96.04 |
1.779 |
1.7x10-5 |
25.05 |
8.58 |
955.39 |
111.39 |
1.779 |
1.7x10-5 |
As a deviation from the OECD guideline resp. the EEC guideline and in accordance with the US guideline 40 CFR 158.120 section 63 -9, only the determination of the vapour pressure at 25°C was done.
The section 63 -9 of the 40 CFR 158.120 states that:
1) "Vapour pressure shall be determined at 25°C"
2) "If the vapour pressure of an active ingredient is less than 1 x10 -7 torr, information demonstrating that the vapor pressure is below that level satisfies the data requirements of this section"
Description of key information
The study was carried out according to GLP rules.
The study was conducted according to OECD Guideline 104 and Guideline
EEC/84/449 A.4.
The vapour pressure was measured to be 1.7x10-5 Pa with the gas saturation method.
Key value for chemical safety assessment
Additional information
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