Ethyl 4-[[(methylphenylamino)methylene]amino]benzoate

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

Justification for type of information:

The vapour pressure is measured to be 55 Pa at 20 C. According to ECETOC TRA, this makes the substance 'low fugacity' for risk assessment.

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:

From November 22, 2015 to November 25, 2015

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)

Type of method:

static method

Test no.:

#1

Temp.:

20 °C

Vapour pressure:

0.055 kPa

Test no.:

#2

Temp.:

40 °C

Vapour pressure:

0.194 kPa

Test no.:

#3

Temp.:

50 °C

Vapour pressure:

0.374 kPa

Temp.:

25 °C

Vapour pressure:

0.078 kPa

Remarks on result:

other: Estimated vapour pressure value.

Table 1. The test result of sample

Sample	Test Value (kPa)	Blank Value (kPa)	Corrected value (kPa)	Temperature (°C)	Rounded off average value (kPa)
Eversorb EP4	0.221	0.168	0.053	20	0.055
	0.225	0.168	0.057	20
	0.462	0.271	0.191	40	0.194
	0.468	0.271	0.197	40
	0.663	0.293	0.370	50	0.374
	0.672	0.293	0.379	50

 

Conclusions:

According to EU A.4 test method, the saturated vapour pressure of Eversorb EP4 were 0.055 kPa at 20.0°C, 0.078 kPa at 25.0°C, 0.194 kPa at 40.0°C and 0.374 kPa at 50.0°C.

Executive summary:

The vapour pressure of Eversorb EP4 was determined according to EC REGULATION No 761/2009 Annex I A.4 Vapour pressure. Therefore, the saturated vapour pressure of Eversorb EP4 were 0.055 kPa at 20.0°C, 0.078 kPa at 25.0°C, 0.194 kPa at 40.0°C and 0.374 kPa at 50.0°C.

Results and discussion

Clinical signs:

other: