trisodium (2S)-2,6-bis(3-carboxylatopropanamido)hexanoate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

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

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:

2019

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 104 (Vapour Pressure Curve)

Qualifier:

according to guideline

Guideline:

EU Method A.4 (Vapour Pressure)

GLP compliance:

yes (incl. QA statement)

Type of method:

effusion method: Knudsen cell

Specific details on test material used for the study:

Test item identification: Trisodium (2S)-2,6-bis(3-carboxylato propanamido)hexanoate_Disuccinyl Lysine Sodium salt
Purity: 95.50 % w/w (from the Test Substance Data Sheet)
Batch number: 23ADB/50
Internal number: 1900140-001
Production date: November 22, 2018
Expiry date: November 21, 2023
Chemical name: Trisodium (2S)-2,6-bis(3-carboxylato propanamido)hexanoate_Disuccinyl Lysine Sodium salt

Temp.:

ca. 20 °C

Vapour pressure:

0.001 mm Hg

Vapour pressure results:

Temperature [°C]	m [mg]	t [min]	Temperature [K]
27.6	0.2392	80	300.75
33.6	0.2782	80	306.75
39.3	0.3272	80	312.45
46.4	0.3813	80	319.55
53.2	0.4304	80	326.35
61.1	0.5239	80	334.25
68.6	0.6565	80	341.75
1/Temperature [1/K]	m/ t [kg/s]	Vapour pressure [Pa]	log p
3.33E-03	4.98E-11	2.33E-01	-0.6331
3.26E-03	5.80E-11	2.73E-01	-0.5632
3.20E-03	6.82E-11	3.25E-01	-0.4888
3.13E-03	7.94E-11	3.82E-01	-0.4174
3.06E-03	8.97E-11	4.36E-01	-0.3603
2.99E-03	1.09E-10	5.37E-01	-0.2697
2.93E-03	1.37E-10	6.81E-01	-0.1669
y =mx +q	Parameterm (slope)	Parameterq (intercept)	ParameterR2 (correlation)
	-1131	3	0.99466
Extrapolation at 20°C	1/Temperature [1/K]	log p	Vapour pressure [Pa]
	0.00341	-0.7344	1.84 x 10-1

Conclusions:

The test item vapour pressure can be estimated as follows:
P = 1.84 x 10 -1 Pa = 1.38 x 10 -3 mmHg at 20°C

Executive summary:

A test according to: OECD Guideline No. 104 and EC method A.4. was performed to determine the vapour pressure of the test item.

The test item vapour pressure can be estimated as follows:

P = 1.84 x 10 -1 Pa = 1.38 x 10 -3 mmHg at 20°C