Miristalkonium chloride

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:

appearance / physical state / colour

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From May 22, 2007 to July 20, 2007

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:

no guideline followed

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Chemical name: C14 ADBAC
Lot/batch number: 612212
Expiry date: 21 December 2009
Percent active substance: 99.1%
Appearance: White powder
Storage conditions: Room temperature

Physical state at 20°C and 1013 hPa:

solid

Key result

Form:

solid

Remarks:

powder

Colour:

White

Odour:

ammonia-like

Substance type:

organic

The colour of test substance was determined under normal daylight, by the Munsell colour system, to be N 9.5/90.0% R (white) at 20°C and 101.3 kPa.

Conclusions:

Under study conditions, the test substance was determined as white powder with an ammonia like odour.

Executive summary:

A study was conducted to determine the appreance, physical state and odour of the test substance, C14 ADBAC, in compliance with GLP. The colour of test substance was determined under normal daylight, by the Munsell colour system, to be N 9.5/90.0% R (white) at 20°C and 101.3 kPa. The physical state of test substance was observed to be a white powder, while an odour was an ammonia-like at 20°C and 101.3 kPa (Sydney 2007).

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 May 22, 2007 to July 20, 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 104 (Vapour Pressure Curve)

Deviations:

not specified

Qualifier:

according to guideline

Guideline:

EU Method A.4 (Vapour Pressure)

Deviations:

not specified

GLP compliance:

yes (incl. QA statement)

Type of method:

effusion method: vapour pressure balance

Specific details on test material used for the study:

Chemical name: C14 ADBAC
Lot/batch number: 612212
Expiry date: 21 December 2009
Percent active substance: 99.1%
Appearance: White powder
Storage conditions: Room temperature

Key result

Test no.:

#1

Temp.:

ca. 25 °C

Vapour pressure:

ca. 0 Pa

Key result

Test no.:

#2

Temp.:

ca. 25 °C

Vapour pressure:

ca. 0 Pa

Key result

Temp.:

ca. 25 °C

Vapour pressure:

ca. 0 Pa

Remarks on result:

other: Mean vapour pressure value

Results:

	Run 1	Run 2
Correlation:	-0.9206	-0.9839
Slope:	-6516	-5722
Intercept	18.08	15.47
Vapour pressure (Pa) at 25ºC	1.7 × 10 -4	1.9 × 10 -4

Mean vapour pressure value of 1.8 × 10 -4 Pa at 25ºC.

Conclusions:

Under study conditions, the mean vapour pressure of test substance was determined to be 1.8 × 10-4 Pa at 25ºC.

Executive summary:

A study was conducted to determine the vapor pressure of the test substance, C14 ADBAC, according to the OECD Guideline 104 and EU Method A.4, in compliance with GLP. Under study conditions, the mean vapour pressure of test substance was determined to be 1.8 × 10-4 Pa at 25ºC (Sydney 2007).

Cross-reference 3

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Particle size distribution of the test substance was determined using laser scattering/diffraction and sieving methods, according to the OECD Guideline 110, (Moller, 2018).

Particle size distribution: 65% > 2000 µm and 35% < 2000 µm (35% <250 µm; 35% of <200 µm; 31% <100 µm; 22.4% <50 µm), 2.9% < 10 µm; median particle size (D50) of fine fraction: 36 µm