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Diss Factsheets
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EC number: 944-090-8 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
The effects on fertility of Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) via the oral route is expected to be driven by the effects on fertility of its constituents – 6-[[(4-methylphenyl)sulphonyl]amino]hexanoic acid, morpholine, and water.
Reliable data on 6-[[(4-methylphenyl)sulphonyl]amino]hexanoic acid was used to derive a NOAEL(fertility) = 1,600 mg/kg bw/day.
It was not possible to identify in the literature any studies investigating the effects of morpholine to fertility or reproductive organs following exposure via the oral route. Repeated-dose toxicity studies performed on morpholine via inhalation and investigating the effects of the substance to reproductive organs did not report any effects.
Water is included in Annex IV of REACH and is not considered as toxic to reproduction.
It is considered a conservative approach to apply to the substance the lowest NOAEL derived for its individual constituents, therefore with a NOAEL(fertility) = 1,600 mg/kg bw/day of Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1).
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- other: An assessment was undertaken based on available data on the individual constituents of the substance
- Adequacy of study:
- key study
- Study period:
- 2017
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: An assessment was undertaken based on available data on the individual constituents of the substance
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- An assessment was undertaken based on available data on the individual constituents of the substance.
- GLP compliance:
- no
- Limit test:
- no
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- maternal toxicity
- Effect level:
- 75 mg/kg bw/day (nominal)
- Based on:
- other: maternal toxicity induced by one of the constituents of the substance
- Sex:
- female
- Basis for effect level:
- food consumption and compound intake
- haematology
- organ weights and organ / body weight ratios
- Remarks on result:
- other: An assessment was undertaken based on available data on the individual constituents of the substance
- Dose descriptor:
- NOAEL
- Remarks:
- fertility
- Effect level:
- 1 600 mg/kg bw/day (nominal)
- Based on:
- other: No effects on fertility were observed for the constituents of the substance at up to 1,600 mg/kg bw/d
- Sex:
- male/female
- Remarks on result:
- other: An assessment was undertaken based on available data on the individual constituents of the substance
- Key result
- Critical effects observed:
- no
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- developmental toxicity
- Generation:
- F1
- Effect level:
- 400 mg/kg bw/day (nominal)
- Based on:
- other: suspected developmental toxicity induced by one of the constituents of the substance at 1,600 mg/kg bw/d
- Sex:
- male/female
- Basis for effect level:
- mortality
- Remarks on result:
- other: An assessment was undertaken based on available data on the individual constituents of the substance
- Key result
- Critical effects observed:
- no
- Key result
- Reproductive effects observed:
- not specified
- Conclusions:
- An assessment of the toxicity to reproduction of the registered substance was undertaken based on available data on its individual constituents. None of these constituents meet the criteria for classification as toxic to reproduction according to Regulation (EC) N° 1272/2008. It is therefore considered that Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) does not meet the criteria for classification as toxic to reproduction.
- Executive summary:
The toxicity to reproduction of Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) via the oral route is expected to be driven by the toxicity to reproduction of its constituents – 6-[[(4-methylphenyl)sulphonyl]amino]hexanoic acid, morpholine, and water.
Reliable data on 6-[[(4-methylphenyl)sulphonyl]amino]hexanoic acid was used to derive a NOAEL(fertility) = 1,600 mg/kg bw/day, a NOAEL(maternal toxicity) = 400 mg/kg bw/day and a NOAEL(developmental toxicity) = 400 mg/kg bw/day.
It was not possible to identify in the literature any studies investigating the effects of morpholine to fertility or reproductive organs following exposure via the oral route. Repeated-dose toxicity studies performed on morpholine via inhalation and investigating the effects of the substance to reproductive organs did not report any effects. The available information on morpholine allowed to derive a NOAEL(maternal toxicity) = 75 mg/kg bw/day and a NOAEL(developmental toxicity) = 750 mg/kg bw/day for the oral route.
Water is included in Annex IV of REACH and is not considered as toxic to reproduction.
None of the constituents of Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) is classified as toxic to reproduction therefore the substance is not considered as toxic to reproduction.
It is considered a conservative approach to apply to the substance the lowest NOAEL derived for its individual constituents, therefore with a NOAEL(fertility) = 1,600 mg/kg bw/day, NOAEL(maternal toxicity) = 75 mg/kg bw/day, and NOAEL(developmental toxicity) = 400 mg/kg bw/day of Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1).
Reference
See attached document
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 600 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- An assessment was undertaken based on available data on the individual constituents of the substance
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
The developmental toxicity of Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) via the oral route is expected to be driven by the developmental toxicity of its constituents – 6-[[(4-methylphenyl)sulphonyl]amino]hexanoic acid, morpholine, and water.
Reliable data on 6-[[(4-methylphenyl)sulphonyl]amino]hexanoic acid was used to derive a NOAEL(maternal toxicity) = 400 mg/kg bw/day and a NOAEL(developmental toxicity) = 400 mg/kg bw/day.
The available information on morpholine was used to derive a NOAEL(maternal toxicity) = 75 mg/kg bw/day and a NOAEL(developmental toxicity) = 750 mg/kg bw/day for the oral route.
Water is included in Annex IV of REACH and is not considered as toxic to reproduction.
It is considered as a conservative approach to apply to the substance the lowest NOAEL derived for its individual constituents, therefore with a NOAEL(maternal toxicity) = 75 mg/kg bw/day and a NOAEL(developmental toxicity) = 400 mg/kg bw/day of Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1).
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 400 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- An assessment was undertaken based on available data on the individual constituents of the substance
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
An assessment of the toxicity to reproduction of the registered substance was undertaken based on available data on its individual constituents. None of these constituents meet the criteria for classification as toxic to reproduction according to Regulation (EC) N° 1272/2008. It is therefore considered that Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) does not meet the criteria for classification as toxic to reproduction.
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.