Salts of phosphoric acid, 2-ethylhexyl esters with C16-18 (even numbered) and C18-unsaturated-alkylamines

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Data waiving:

exposure considerations

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
According to conditions described in Column 2 of Section 8.5.2 of Annex VIII testing by the inhalation route is appropriate if exposure of humans via inhalation is 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.
As the substance has a low vapor pressure (6.1 x 10-7 Pa at 25°C), therfore exposure by inhalation of vapor is unlikely to occur. Furthermore the substance is only used as a liquid substance (as such or in a formulation (of lubricant additives, lubricants and greases)). Based on its use the possibility of exposure of workers to aerosols, particles or droplets of an inhalable size can be excluded. Since the criteria in Column 2 of Section 8.5.2 are not fulfilled testing by the inhalation route for the substance is considered not appropriate and thus testing is waived.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

vapour pressure

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19 Jun 2019 - 02 Aug 2019

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method A.4 (Vapour Pressure)

Version / remarks:

2016

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 104 (Vapour Pressure Curve)

Version / remarks:

2006

Deviations:

no

GLP compliance:

yes

Type of method:

effusion method: isothermal thermogravimetry

Specific details on test material used for the study:

Decomposition: 200°C

Key result

Temp.:

20 °C

Vapour pressure:

0 Pa

Key result

Temp.:

25 °C

Vapour pressure:

0 Pa

Table: Results of the vapour pressure isothermal TGA analysis (substance)

Temperature [°C]	Weight loss [µg/min]	νT [g/cm^2/h]	log νT	log PT	PT [Pa]
150	1.69063	2.02 x 10^-4	-3.70	0.38	2.4
	1.61590	1.93 x 10^-4	-3.71	0.36	2.3
160	3.05539	3.65 x 10^-4	-3.44	0.71	5.1
	3.02549	3.61 x 10^-4	-3.44	0.70	5.0
170	6.23354	7.44 x 10^-4	-3.13	1.10	13
	5.80625	6.93 x 10^-4	-3.16	1.06	11
180	11.2987	1.35 x 10^-3	-2.87	1.43	27
	10.2183	1.22 x 10^-3	-2.91	1.37	23

 

Conclusions:

The vapour pressure of the substance at 20°C and 25°C was determined to be 2.5E-7 Pa and 6.1E-7 Pa, respectively.

Executive summary:

The vapour pressure of the substance was determined using the isothermal thermogravimetric effusion method in a GLP study based on EC A.4, OECD 104 and OPPTS 830.7950. Validation of the method was performed using a set of five reference substances.

The vapour pressure regression curve (log PT as function of 1/T; with T in K) of the substance was constructed from weight losses measured at 150°C, 160°C, 170°C and 180°C.

The vapour pressure of the substance at 20°C and 25°C was calculated from the vapour pressure curve to be 2.5E-7 Pa and 6.1E-7 Pa, resp.

Cross-reference 2

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Registration/ Notification status for the use:

use registered according to REACH Article 10; total tonnage manufactured/imported >=10tonnes/year per registrant

Manufacture name:

Manufacture of the substance

Name of activity / technique:

Manufacture of the substance

Environmental release category (ERC):

ERC1: Manufacture of the substance

Name of activity / technique:

Use in closed process, no likelihood of exposure

Process category (PROC):

PROC 1: Chemical production or refinery in closed process without likelihood of exposure or processes with equivalent containment conditions

Name of activity / technique:

Use in closed, continuous process with occasional controlled exposure

Process category (PROC):

PROC 2: Chemical production or refinery in closed continuous process with occasional controlled exposure or processes with equivalent containment conditions

Name of activity / technique:

Use in closed batch process (synthesis or formulation)

Process category (PROC):

PROC 3: Manufacture or formulation in the chemical industry in closed batch processes with occasional controlled exposure or processes with equivalent containment conditions

Name of activity / technique:

Use in batch and other process (synthesis) where opportunity for exposure arises

Process category (PROC):

PROC 4: Chemical production where opportunity for exposure arises

Name of activity / technique:

Mixing or blending in batch processes for formulation of preparations and articles (multistage and/or significant contact)

Process category (PROC):

PROC 5: Mixing or blending in batch processes

Name of activity / technique:

Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at non-dedicated facilities

Process category (PROC):

PROC 8a: Transfer of substance or mixture (charging and discharging) at non-dedicated facilities

Name of activity / technique:

Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at dedicated facilities

Process category (PROC):

PROC 8b: Transfer of substance or mixture (charging and discharging) at dedicated facilities

Name of activity / technique:

Transfer of substance or preparation into small containers (dedicated filling line, including weighing)

Process category (PROC):

PROC 9: Transfer of substance or mixture into small containers (dedicated filling line, including weighing)

Related assessment:

use assessed in an own CSR

Cross-reference 3

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Registration/ Notification status for the use:

use registered according to REACH Article 10; total tonnage manufactured/imported >=10tonnes/year per registrant

Use name:

Formulation of lubricant additives

Name of activity / technique:

Formulation of lubricant additives

Environmental release category (ERC):

ERC2: Formulation into mixture

Name of activity / technique:

Use in closed process, no likelihood of exposure

Process category (PROC):

PROC 1: Chemical production or refinery in closed process without likelihood of exposure or processes with equivalent containment conditions

Name of activity / technique:

Use in closed, continuous process with occasional controlled exposure

Process category (PROC):

PROC 2: Chemical production or refinery in closed continuous process with occasional controlled exposure or processes with equivalent containment conditions

Name of activity / technique:

Use in closed batch process (synthesis or formulation)

Process category (PROC):

PROC 3: Manufacture or formulation in the chemical industry in closed batch processes with occasional controlled exposure or processes with equivalent containment conditions

Name of activity / technique:

Use in batch and other process (synthesis) where opportunity for exposure arises

Process category (PROC):

PROC 4: Chemical production where opportunity for exposure arises

Name of activity / technique:

Mixing or blending in batch processes for formulation of preparations and articles (multistage and/or significant contact)

Process category (PROC):

PROC 5: Mixing or blending in batch processes

Name of activity / technique:

Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at non-dedicated facilities

Process category (PROC):

PROC 8a: Transfer of substance or mixture (charging and discharging) at non-dedicated facilities

Name of activity / technique:

Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at dedicated facilities

Process category (PROC):

PROC 8b: Transfer of substance or mixture (charging and discharging) at dedicated facilities

Name of activity / technique:

Transfer of substance or preparation into small containers (dedicated filling line, including weighing)

Process category (PROC):

PROC 9: Transfer of substance or mixture into small containers (dedicated filling line, including weighing)

Name of activity / technique:

Use as laboratory agent

Process category (PROC):

PROC 15: Use as laboratory reagent

Product category formulated:

PC 17: Hydraulic fluids

PC 24: Lubricants, greases, release products

PC 25: Metal working fluids

Substance supplied to that use in form of:

as such

Related assessment:

use assessed in an own CSR