calcium N2,N6-bis(3-carboxypropanoyl)lysine (1:1)

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Data waiving:

other justification

Justification for data waiving:

the study does not need to be conducted because exposure of humans via inhalation is not 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

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 February 20th to March 09th, 2009

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:

1981

Qualifier:

according to guideline

Guideline:

EU Method A.4 (Vapour Pressure)

GLP compliance:

yes

Remarks:

temporary certificate

Type of method:

gas saturation method

Key result

Temp.:

20 °C

Vapour pressure:

< 0.002 Pa

Remarks on result:

not determinable because of methodological limitations

From the experimental data obtained in the present study it is concluded that the vapour pressure of the sample is:

P < 1.75 mPa (i.e. < 1.33 x 10^-5 mmHg) at 32 °C

P < 2.05 mPa (i.e. < 1.55 x 10^-5 mmHg) at 40 °C

therefore: P < 1.75 mPa (i.e. < 1.33 x 10^-5mmHg) at 20 and 25 °C

Conclusions:

From the data obtained it can be conclude the vapour pressure at 20 and 25°C is < 1.75 mPa

Executive summary:

The test was conducted according to the OECD Guideline 104..

From the experimental data obtained in the present study it is concluded that the vapour pressure of the sample is:

P < 1.75 mPa (i.e. < 1.33 x 10^-5mmHg) at 32 °C

P < 2.05 mPa (i.e. < 1.55 x 10^-5mmHg) at 40 °C

therefore: P < 1.75 mPa (i.e. < 1.33 x 10^-5mmHg) at 20 and 25 °C

Cross-reference 2

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:

March 18th, 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)

Version / remarks:

May, 1981

Qualifier:

according to guideline

Guideline:

other: CIPAC MT 187 "Particle size analysis by laser diffraction"

GLP compliance:

yes

Remarks:

temporary certificate

Type of method:

Laser scattering/diffraction

Type of distribution:

volumetric distribution

Percentile:

D90

Mean:

< 62.21 µm

Remarks on result:

other: no st. dev. available

Percentile:

D50

Mean:

< 23.63 µm

Remarks on result:

other: no st. dev. available

Percentile:

D10

Mean:

< 6.6 µm

Remarks on result:

other: no st. dev. available

No.:

#1

Size:

< 2 µm

Distribution:

2.33 %

No.:

#2

Size:

< 10 µm

Distribution:

18.42 %

No.:

#3

Size:

< 50 µm

Distribution:

83.56 %

No.:

#4

Size:

< 75 µm

Distribution:

6.2 %

No.:

#5

Size:

< 100 µm

Distribution:

97.16 %

Conclusions:

MMD = 23.63 µm

Executive summary:

The test item was analysed by means of laser scattering and according to OECD 110. Under the test condition the Mass Median Diameter results to be 23.63 µm