Registration Dossier
Registration Dossier
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EC number: 944-090-8 | CAS number: -
Endpoint summary
Administrative data
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- other: expert assessment
- Adequacy of study:
- key study
- Study period:
- 2017
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: An assessment of the toxicokinetics behaviour of the substance was performed using results from existing toxicological studies and information on its individual constituents
- Objective of study:
- toxicokinetics
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- An assessment of the toxicokinetics behaviour of the substance was performed using results from existing toxicological studies and information on its individual constituents
- GLP compliance:
- no
- Type:
- absorption
- Results:
- Absorption of some constituents of the substance is expected following exposure via oral, dermal, or inhalation but could not be confirmed by experimental data.
- Details on absorption:
- Oral exposure:
- An acute oral toxicity study was performed on the substance. When tested at up to 2,000 mg/kg bw the substance did not induce adverse effects. It is not possible to determine if this result is a consecutive to a lack of absorption or the lack of acute oral toxicity of Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1).
Inhalation exposure:
- Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) has a vapour pressure of 18.1 mmHg at 20°C equivalent to 2.4 kPa at 20°C. This value is likely due to the vapour pressure of water (2.3 kPa at 20°C) which constitutes approximately 40% of the substance.
- Based on the uses of the substance no exposure via inhalation of Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) is expected.
- There is no data available on the effects of the substance following an inhalation exposure.
Dermal exposure:
- Based on the uses of the substance no exposure via the dermal route of Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) is expected.
- Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) was identified as a skin irritant. It could therefore be expected to damage the skin and enhance the dermal absorption of its constituents.
- There is no data available on the systemic effects of the substance following a dermal exposure. - Details on distribution in tissues:
- Acute toxicity study performed on the substance did not allow to identify target organs and therefore to confirm the distribution of Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) in the body based on the properties of its constituents.
- Details on excretion:
- There is no data available on the elimination of Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1). It is therefore not possible to confirm the expected metabolisation of the substance based on the properties of its constituents.
- Metabolites identified:
- no
- Details on metabolites:
- There is no data available on the metabolisation of Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1). It is therefore not possible to confirm the expected metabolisation of the substance based on the properties of its constituents.
- Conclusions:
- An assessment of the toxicokinetics behaviour of the substance was performed using results from existing toxicological studies and information on its individual constituents.
- Executive summary:
The absence of specific toxicokinetics data from animal testing means that it is not possible to make firm conclusions concerning the absorption, distribution, metabolisation and excretion of Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1).
It is expected that the individual constituents of the substance will behave independently following exposure. Therefore the toxicokinetics behaviour of Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) is expected to be driven by the toxicokinetics behaviour of morpholine and 6-[[(4-methylphenyl)sulphonyl]amino]hexanoic acid. Water was not taken into account as part of this assessment as it is a well-known substance considered to cause minimum risk due to its intrinsic properties in accordance with Annex IV of REACH.
It is expected that morpholine and 6-[(p-tosyl)amino]hexanoic acid will be well absorbed and distributed following exposure by the oral route. Available animal data on the substance do not allow confirmation that absorption occurs following oral exposure to Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1). Based on the uses of the substance, no exposure via inhalation or the dermal route of Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) is expected.
Metabolisation of morpholine is expected to be very limited. No data is available on the metabolites of morpholine, 6-[(p-tosyl)amino]hexanoic acid and Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1).
The constituents of Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) are expected to be eliminated mostly via urine with a fraction in the faeces.
It is not considered justified to perform animal studies on this substance to further investigate its toxicokinetic behaviour.
Reference
Description of key information
The absence of specific toxicokinetics data from animal testing means that it is not possible to make firm conclusions concerning the absorption, distribution, metabolisation and excretion of Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1).
It is expected that the individual constituents of the substance will behave independently following exposure. Therefore the toxicokinetics behaviour of Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) is expected to be driven by the toxicokinetics behaviour of morpholine and 6-[[(4-methylphenyl)sulphonyl]amino]hexanoic acid. Water was not taken into account as part of this assessment as it is a well-known substance considered to cause minimum risk due to its intrinsic properties in accordance with Annex IV of REACH.
It is expected that morpholine and 6-[(p-tosyl)amino]hexanoic acid will be well absorbed and distributed following exposure by the oral route. Available animal data on the substance do not allow confirmation that absorption occurs following an oral exposure to Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1). Based on the uses of the substance, no exposure via inhalation or the dermal route of Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) is expected.
Metabolisation of morpholine is expected to be very limited. No data is available on the metabolites of morpholine, 6-[(p-tosyl)amino]hexanoic acid and Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1).
The constituents of Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) are expected to be eliminated mostly via urine with a fraction in the faeces.
It is not considered justified to perform animal studies on this substance to further investigate its toxicokinetic behaviour.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
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