Reaction mass of hexadecyl dihydrogen phosphate and cetyl alcohol (mono- C16 PSE and C16-OH)

Repeated dose toxicity: inhalation

Administrative data

Endpoint:

short-term repeated dose 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:

vapour pressure

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From July 18, 2017 to August 24, 2017

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

EU Method A.4 (Vapour Pressure)

Deviations:

no

GLP compliance:

yes

Type of method:

static method

Key result

Test no.:

#2

Temp.:

ca. 20.4 °C

Vapour pressure:

< 1 Pa

Remarks on result:

other: Estimated based on individual components vapour pressure

Conclusions:

Under the study conditions, the vapour pressure could not be determined. Based on SDS the vapour pressure is expected to be <1 Pa at 20.4˚C.

Executive summary:

A study was conducted to determine the vapour pressure of the test substance using static method, according to EU Method A.4, in compliance with GLP. During the study pressure equilibration was not achieved over 7 h therefore experimental determination of the vapour pressure was terminated. Based on available information (SDS), the vapour pressure of the individual components was estimated as less than 1 Pa. However there was suspicion that some impurities may be causing the increase in vapour observed in the experimental determination. Under the study conditions, the estimated vapour pressure of the test substance based on the individual components is determined to be <1 Pa at 20.4˚C (Chilworth, 2017).

Cross-reference 2

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

Colour:

Off white

Substance type:

organic

Conclusions:

The substance is an off white solid.

Executive summary:

The physical state and appearance of the test substance were visually observed during testing of other endpoint testing. The purified form of the test substance is an off white solid (Chilworth, 2017).

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:

From July 18, 2017 to August 24, 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Qualifier:

according to guideline

Guideline:

other: Microscopic and manual sieve analysis method

Deviations:

not specified

GLP compliance:

yes

Type of method:

other: Microscopic and manual sieve analysis

Type of particle tested:

other: Sample tested as received

Type of distribution:

mass based distribution

Mass median aerodynamic diameter:

> 2 000 µm

No.:

#1

Size:

> 2 000 µm

Distribution:

ca. 100 other: % by weight

No.:

#2

Size:

< 2 000 µm

Distribution:

ca. 0 other: % by weight

Results

a) Standard visual observation

Sample observed to be an amorphous non-dusting off-white solid.

b) Observation using 3.2 objective lens

The particles appeared to be irregular shaped particles. All particles were > 2000 μm.

c) Observation using 40 objective lens

The sample was observed to be a solid block with some broken bits. All particles were > 2000 μm.

Full test results

Sieve size (μm)	Sieve weight (g)	Sieve + powder weight (g)	Powder weight (g)	% by weight
< 2000	352.25	352.25	0	0
> 2000	325.88	329.14	3.3	100
		Total	3.3	100

Comments

The sample was found to be a solid block with a few broken bits. During the sieve analysis, only 3.3 g of the sample poured into the sieve. The remaining portion of the sample remained as a solid block. All the particles that went into the sieve were > 2000 μm. Because these particles were greater than the upper limit of detection for the distribution analysis, no further testing was performed.

Conclusions:

Under the study conditions, the test substance particles were determined to be > 2000 μm.

Executive summary:

A study was conducted to determine the particle size distribution of the test substance, using microscopic examination and manual sieve analysis, in compliance with GLP. In the microscopic visual examination, the test substance was observed to be an amorphous non-dusting off-white solid. While using 3.2 objective lens, the particles appeared to be irregular shaped particles, in which all particles were > 2000 μm. Observation using 40 objective lens, the sample was observed to be a solid block with some broken bits, with all particles were > 2000 μm. During the sieve analysis, only 3.3 g of the sample poured into the sieve. The remaining portion of the sample remained as a solid block. All the particles that went into the sieve were > 2000 μm. Because these particles were greater than the upper limit of detection for the distribution analysis, no further testing was performed. Under the study conditions, the test substance particles were determined to be > 2000 μm (Chilworth, 2017).