Reaction mass of orthophosphoric acid and potassium dihexadecyl phosphate and dipotassium hexadecyl phosphate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

appearance / physical state / colour

Type of information:

experimental study

Adequacy of study:

key study

Study period:

September, 2017

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Appearance based on observations from other testing endpoints conducted for this substance

Reason / purpose for cross-reference:

reference to other study

Principles of method if other than guideline:

Observations based on the observations made during testing for other endpoints

GLP compliance:

yes

Physical state at 20°C and 1013 hPa:

solid

Key result

Form:

solid: particulate/powder

Colour:

White

Substance type:

organic

Conclusions:

The substance is a white solid powder.

Executive summary:

The physical state and appearance of the test substance were visually observed during testing of other endpoints. The purified form of the test substance was identified to be a white solid powder (Chilworth, 2017).

Cross-reference 2

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

The vapour pressure of the test substance was determined experimentally using the static method, according to EU A.4 Method (Chilworth, 2017) as well using QSAR model of EPI Suite (US EPA, 2018).

Vapour pressure:

8 Pa

at the temperature of:

20 °C

- Experimental VP: 8 Pa at 20°C (using static method); study result suspected to be influenced by trapped impurities/gases.

- Weighted average QSAR based VP = 1.60E-4 Pa at 25°C (using EPI Suite v.4.11). The estimates for the major constituents are considered to be reliable with restrictions, as they do not completely fall within of the applicability domain.

Overall, based on the above information, the test substance can be considered to have low volatility. As a conservative approach the higher vapour pressure value of 8 Pa has been considered further for hazard/risk assessment as a conservative approach.

Cross-reference 3

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

February 28, 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods

Qualifier:

according to guideline

Guideline:

other: ISO 17892-4:2004 Geotechnical investigation and testing -- Laboratory testing of soil -- Part 4: Determination of particle size distribution

Version / remarks:

2004

Deviations:

not specified

GLP compliance:

not specified

Type of method:

sieving

Type of particle tested:

primary particle

Type of distribution:

mass based distribution

Mass median aerodynamic diameter:

ca. 63 - ca. 600 µm

Remarks on result:

other: Standard deviation values were not provided the study report

Key result

Percentile:

other: D99.4

Mean:

ca. 63 - ca. 600 µm

Remarks on result:

other: Standard deviation values not provided

No.:

#1

Size:

> 600 µm

Distribution:

ca. 1.592 %

No.:

#2

Size:

> 500 µm

Distribution:

ca. 0.29 %

No.:

#3

Size:

> 355 µm

Distribution:

ca. 3.536 %

No.:

#4

Size:

> 250 µm

Distribution:

ca. 3.508 %

No.:

#5

Size:

> 212 µm

Distribution:

ca. 5.338 %

No.:

#6

Size:

> 150 µm

Distribution:

ca. 9.391 %

No.:

#7

Size:

> 90 µm

Distribution:

ca. 21.035 %

No.:

#8

Size:

> 63 µm

Distribution:

ca. 35.163 %

No.:

#9

Size:

< 63 µm

Distribution:

ca. 19.59 %

Results

Sieve (µm)	Weight of retained sample	Cumulative weigh (g)	Total sample weight (%)	Accumulated sample (%)	Test substance not retained (%)
600	0.801	0.801	1.592	1.592	98.408
500	0.146	0.947	0.29	1.882	98.118
355	1.7789	2.726	3.536	5.418	94.582
250	1.765	4.491	3.508	8.926	91.074
212	2.686	7.177	5.338	14.264	85.736
150	4.7251	11.902	9.391	23.655	76.345
90	10.5835	22.486	21.035	44.69	55.31
63	17.6919	40.177	35.163	79.853	20.147
End receiver	9.8565	50.034	19.59	99.443	0.557

Total mass measured was 50.0339 g (99.4% of initial mass).

Discussion

The sample was analysed using the sieve method down to an aperture of 63 µm. Analysis of the sample fraction passing through this mesh (20.147% of sample mass) has not been carried out and would require alternative methodology. 1.592% of the sample mass did not pass the 600 µm sieve, the largest aperture used. Visual examination of the retained particles indicated that these were all marginally larger than the sieve mesh and there were no anomalously large particles or agglomerations present. The particle sizes of the sample therefore formed a continuous and consistent distribution. The recovery of test substance from the experiment was 99.4%. Therefore, the validity criteria for this study (>99% recovery) was met.

Conclusions:

Under the study conditions, the particle size distribution of the test substance was determined continous and consistance (600 to 63 µm).

Executive summary:

A study was conducted to determine the particle size distribution of the test substance, mono- and di- C16 PSE, K+ H3PO4, according to ISO 17892-4 : 2004, using granulometry by sieving method. The sieves were stacked in mesh size order from largest aperture (top - 600 µm) to smallest aperture (bottom - 63 µm) and the sample aliquot weighed into a glass bowl (50.3142g). This was emptied into the top sieve and the bowl brushed out with a soft brush. The stack of sieves were placed on a mechanical shaker for 5 minutes at 95 rpm followed by 2 minutes manual agitation. The sieves were turned by 45° after each minute of shaking. Sieves were then removed consecutively from the stack and the contents carefully transferred to a weighing bowl. The sieve was brushed down with a soft brush to ensure quantitative transfer of material. The sample was analysed using the sieve method down to an aperture of 63 µm. Analysis of the sample fraction passing through this mesh (20.147% of sample mass) has not been carried out and would require alternative methodology. 1.592% of the sample mass did not pass the 600µm sieve, the largest aperture used. Visual examination of the retained particles indicated that these were all marginally larger than the sieve mesh and there were no anomalously large particles or agglomerations present. The particle sizes of the sample therefore formed a continuous and consistent distribution. The recovery of test substance from the experiment was 99.4%. Therefore, the validity criteria for this study (>99% recovery) was met. Under the study conditions, the particle size distribution of the test substance was determined continous and consistance (600 to 63 µm) (Chemex, 2018).