Registration Dossier
Registration Dossier
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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
Description of key information
An assessment on the short-term repeated dose toxicity of Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) following exposure via the oral route was undertaken based on available data on the individual constituents of the substance. It concluded that is not necessary to conduct a new study on the short-term repeated dose toxicity of Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1), because substantial repeated dose toxicity data is already available in the literature for the constituents of the reaction mass and the repeated-dose toxicity of the substance is expected to be driven by its individual constituents.
Using the most conservative approach, the lowest value across the two constituent substances of the reaction mass has been taken. This approach is considered to be conservative. Therefore, it can be concluded that the short-term repeated dose toxicity value for Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) is NOAEL = 140 mg/kg bw.
In accordance with Annex VIII of REACH, Column 2, testing by the inhalation and dermal routes is only appropriate if exposure of humans via these routes is likely. No significant exposure to Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) is expected taking into account the uses of the substance. Therefore no exposure of humans via the dermal and inhalation routes is expected.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- 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:
- May 15, 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
- Gross pathological findings:
- effects observed, treatment-related
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 140 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- body weight and weight gain
- urinalysis
- Critical effects observed:
- not specified
- Conclusions:
- An assessment was undertaken based on available data on the individual constituents of the substance. It is concluded that Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) has a NOAEL = 140 mg/kg bw/d and
- Executive summary:
An assessment on the short-term repeated dose toxicity of Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) following exposure via the oral route was undertaken based on available data on the individual constituents of the substance. It concluded that is not necessary to conduct a new study on the short-term repeated dose toxicity of Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1), because substantial repeated dose toxicity data is already available in the literature for the constituents of the reaction mass and the repeated-dose toxicity of the substance is expected to be driven by its individual constituents.
Using the most conservative approach, the lowest value across the two constituent substances of the reaction mass has been taken. This approach is considered to be conservative. Therefore, it can be concluded that the short-term repeated dose toxicity value for Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) is NOAEL = 140 mg/kg bw.
Based on the classification of the constituents of the registered substance, it is concluded that it will not trigger the specific target organ toxicity (STOT) classification in accordance with Regulation (EC) N° 1272/2008.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 140 mg/kg bw/day
- Study duration:
- subacute
- Species:
- other: Data obtained on several species were considered as part of the assessment of the repeated-dose toxicity of the registered substance
Repeated dose toxicity: inhalation - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- a short-term toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
In accordance with REACH, Annex XI, no testing is required as no significant inhalation exposure is expected in all scenarios of the manufacture and all identified uses. The substance is only associated with industrial uses and is handled by professional users with protective equipment in controlled conditions. Moreover, the substance will only be used in diluted form.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- a short-term toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
In accordance with REACH, Annex XI, no testing is required as no significant inhalation exposure is expected in all scenarios of the manufacture and all identified uses. The substance is only associated with industrial uses and is handled by professional users with protective equipment in controlled conditions. Moreover, the substance will only be used in diluted form.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- a short-term toxicity study does not need to be conducted because exposure of humans via the dermal route in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
In accordance with REACH, Annex XI, no testing is required as no significant dermal contact is expected in all scenarios of the manufacture and all identified uses. The substance is only associated with industrial uses and is handled by professional users with protective equipment in controlled conditions. Moreover, the substance will only be used in diluted form.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- a short-term toxicity study does not need to be conducted because exposure of humans via the dermal route in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
In accordance with REACH, Annex XI, no testing is required as no significant dermal contact is expected in all scenarios of the manufacture and all identified uses. The substance is only associated with industrial uses and is handled by professional users with protective equipment in controlled conditions. Moreover, the substance will only be used in diluted form.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the classification of the constituents of the registered substance, it is concluded that Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) will not trigger the specific target organ toxicity (STOT) classification in accordance with Regulation (EC) N° 1272/2008.
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.
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