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

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

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 2

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 3

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

The particle size distribution of the test substance was determined using microscopic examination and manual sieve analysis (Chilworth, 2017).

> 2000 μm