Calcium di(octanoate)

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
The substance is formed during the industrial process (it is a soap) and therefore there is no exposure via inhalation nor dermal.

Column 2 of Annex VIII 8.5 states: "In addition to the oral route (Annex VII, 8.5.1.), for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. If there is only one route of exposure, information for only that route needs to be provided." Furthermore Column 2 of Annex VIII 8.5.2 states: "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."

The vapour pressure of the substance if very low (1 x 10-4 Pa at 25 °C) and a boiling point result was not possible to obtain as the substance decomposes before boiling, as such the substance is considered to be of low volatility. Furthermore the possibility of exposure to aerosols, particles or droplets of an inhalable size is not expected as the substance (soap) is formed within the production tank of the grease (mixture). This tank is closed, this process requires heating and the workers will not be in contact with the product whilst it is still hot.

Towards the end of the process, some workers could be in contact with the product during grinding, deaeration, and packaging. Contacts would essentially be by hands. – Workers wear PPE, including chemical gloves and safety glasses. Particle size distribution was not conducted as the substance is marketed or used in a non-solid or granular form and therefore exposure via the inhalation route is not expected.

In conclusion there is no expected exposure via the inhalation route and therefore an acute toxicity inhalation study is not considered to be necessary.

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:

02 May 2018 to 25 May 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 104 (Vapour Pressure Curve)

Version / remarks:

Not reported

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method A.4 (Vapour Pressure)

Version / remarks:

Not reported

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

effusion method: isothermal thermogravimetry

Test no.:

#2

Temp.:

25 °C

Vapour pressure:

0 Pa

Test no.:

#3

Temp.:

25 °C

Vapour pressure:

0 Pa

Temp.:

25 °C

Vapour pressure:

0 Pa

Remarks on result:

other: Mean vapour pressure

For run 1, there was initial high weight losses at lower temperatures. This was indicative of degassing of the sample. Only the data from runs 2 and 3 have therefore been used for calculations.

Table 1: A summary of the run 2 and 3 results

Parameter	Run 2	Run 3
Correlation (R^2)	0.9941	0.9965
Slope	-4134	-4490
Intercept	10.19	10.90
log10PT at 25 °C	-3.7	-4.2
PT (Pa) at 25 °C	0.00021	0.000069

Table 2: Vapour Pressure Measurements (Run 2)

Temperature (°C)	Evaporation rate, VT (g/minute)	log10VT	log10PT
118.63	0.0000002613	-4.098	-0.3745
123.61	0.0000003556	-3.964	-0.2313
128.59	0.0000004873	-3.827	-0.0849
133.58	0.0000006356	-3.712	0.0386
138.56	0.0000007712	-3.628	0.1285

Table 3: Vapour Pressure Measurements (Run 3)

Temperature (°C)	Evaporation rate, VT(g/minute)	log10VT	log10PT
123.64	0.0000002342	-4.145	-0.4253
128.61	0.0000003325	-3.993	-0.2625
133.58	0.0000004368	-3.874	-0.1357
138.55	0.0000005693	-3.759	-0.01259

Conclusions:

The vapour pressure of the test item was determined to be 1 x 10-4 Pa at 25 °C.

Executive summary:

The vapour pressure of the test item was determined in a study following OECD 104 and EC Method A.4 guidelines, using the effusion method. The vapour pressure of the test item was determined to be 1 x 10-4 Pa at 25 °C.

 

The study is a GLP compliant, guideline experimental study and is fully acceptable for assessment of this endpoint.

Cross-reference 2

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

boiling point

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance is a solid which decomposes before boiling

Justification for type of information:

In accordance with column 2 of REACH Annex VII, the boiling point study does not need to be conducted as the substances decompose before boiling.

Cross-reference 3

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

particle size distribution (granulometry)

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance is marketed or used in a non solid or granular form

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
In accordance with column 2 of REACH Annex VII, the granulometry study does not need to be conducted as the substance is marketed or used in a non-solid or granular form.