Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1)

PBT assessment

PBT assessment: overall result

Reference

Name:

Boundary composition_Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1)

Type of composition:

boundary composition of the substance

State / form:

liquid

Reference substance:

Boundary composition_Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1)

Reference substance:

Boundary composition_Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1)

Reference substance:

Boundary composition_Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1)

PBT status:

the substance is not PBT / vPvB

Justification:

The PBT properties of Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) were assessed based on available information on the registered substance and its individual constituents.

 

Persistence

A ready biodegradability study was performed on the registered substance according to the OECD Testing Guideline 306. This study concluded that the substance was not ready biodegradable. After 28 days 19.5% and 26.2% biodegradation were achieved when performing the study with 3 mg/L and 2.5 mg/L of test item respectively.

No conclusion can be reached regarding the P properties of the substance based on the available information.

Since the registered substance is not B/vB and not T it is not considered relevant to further investigate its P properties and therefore to perform further biodegradation testing.

 

Bioaccumulation

The partition coefficient (log Kow) of the salt of the registered substance was determined during a study performed according to the OECD Testing Guideline 117. It was concluded that the substance had a Log Kow ranging from 0.1 to 1.5 at a temperature of 35 ± 1°C. These values are well below 4.5.

The substance does not meet the B or vB criteria.

 

Toxicity

In accordance with Annexes VII and VIII of REACH, no long-term toxicity study on the registered substance were performed for the purpose of this registration and no data on the long-term toxicity for marine/freshwater organisms was identified. Data on short-term toxicity of the registered substance to fish, aquatic invertebrates, and algae was provided. All L(E)C50 for short-term toxicity were above 1 mg/L and therefore above screening values for T properties described in Table R.11-6 of the Guidance on Information Requirements and Chemical Safety Assessment Chapter R.11: PBT/vPvB assessment (ECHA, 2017).

Based on the available information on the registered substance it can be concluded that it does not meet the criteria for classification as mutagenic, toxic to reproduction, or toxic to specific organs following repeated exposure according to Regulation (EC) N° 1272/2008. No data is available on the carcinogenicity of the substance and there is no requirement in Annexes VII and VIII of REACH to investigate this endpoint.

The substance does not meet the T criteria.

 

Conclusion

Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) does not meet the PBT and the vPvB criteria. It is not considered relevant to further investigate the PBT or vPvB properties of the substance.