Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Toxicity to reproduction
Administrative data
- 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
Data source
Reference
- Reference Type:
- other: expert assessment
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- 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
Test material
- Reference substance name:
- morpholin-4-ium morpholine 6-(4-methylbenzenesulfonamido)hexanoate
- EC Number:
- 944-090-8
- Molecular formula:
- C13H19NO4S.C4H9NO/C4H9NO/H2O
- IUPAC Name:
- morpholin-4-ium morpholine 6-(4-methylbenzenesulfonamido)hexanoate
- Test material form:
- liquid
Constituent 1
Results and discussion
Results: P0 (first parental generation)
Effect levels (P0)
open allclose all
- 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
Target system / organ toxicity (P0)
- Key result
- Critical effects observed:
- no
Results: F1 generation
Effect levels (F1)
- 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
Target system / organ toxicity (F1)
- Key result
- Critical effects observed:
- no
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
See attached document
Applicant's summary and conclusion
- 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).
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.