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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 05 October 2017 to 07 November 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- yes
- Remarks:
- On one occasion the temperature and humidity values were not recorded
- Principles of method if other than guideline:
- On one occasion the temperature and humidity values were not recorded. The maximum and minimum values taken the next day were within the required limits therefore they were within limits on the day the recording was not taken. This deviation from protocol therefore had no impact on the integrity or the outcome of the study.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- 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
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd., Margate
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: approximately 8 to 10 weeks old
- Weight at study initiation: 157 to 183 g
- Fasting period before study: from the evening of the day prior to dosing until approximately 3 hours after dosing
- Housing: 5 animals per cage conforming to the 'Code of Practice for the Housing and Care of Animals Bred, Supplied or Used for Scientific Purposes’ (Home Office, London, 2014).
- Diet: 5LF2 EU Rodent Diet 14% ad libitum
- Water: ad libitum
- Acclimation period: 7 to 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24°C
- Humidity (%): 45 to 65%
- Air changes (per hr): 15 to 20
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30 mg/mL or 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: The test item is soluble in water.
- Rationale for the selection of the starting dose: LD50 was assumed to be comprised between 300 and 2,000 mg/kg bw as a worst-case scenario taking into account the acute oral toxicity of one of the constituents of the substance. - Doses:
- A preliminary study was performed at 300 mg/kg bw and 2,000 mg/kg bw. Main study was performed at 2,000 mg/kg bw.
- No. of animals per sex per dose:
- One animal per dose for the preliminary study.
Four animals per dose for the main study. - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were observed at the beginning and the end of the working day for signs of ill health or overt toxicity. Treated rats were observed closely for clinical signs of reaction to treatment. Clinical signs were recorded immediately post-dose, at approximately 15 and 30 minutes post-dose, hourly between 1 and 4 hours post-dose (inclusive), twice daily on Days 2, 3 and 4 and once daily from the fifth to last day of the observation period. Individual records of clinical signs were maintained for each treated rat. Rats were weighed on Day-1 (day before dosing) and on Days 1, 4, 8 and 15.
- Necropsy of survivors performed: yes
Results and discussion
- Preliminary study:
- No animal died during the preliminary study at 300 mg/kg bw or 2,000 mg/kg bw.
Effect levelsopen allclose all
- Key result
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No animal died as a result of the treatment.
- Clinical signs:
- other: No clinical signs were observed.
- Gross pathology:
- No abnormalities were noted at necropsy.
Any other information on results incl. tables
See attached background material
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose (LD50) of the test item in rats was concluded to be above 2,000 mg/kg body weight. Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) does not meet the criteria for classification in accordance with Regulation (EC) No.1272/2008.
- Executive summary:
The acute oral toxicity of the test item Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) was evaluated during a GLP-compliant study performed in accordance with the OECD Testing Guideline 420.
During a preliminary study, one female Wistar rats received a single dose of 300 mg/kg bw of 2,000 mg/kg bw of the test substance. Considering that no death was observed, four female Wistar rats received a single dose of 2,000 mg/kg of the test substance during the main study.
Animals were observed for 14 days following the administration of the test substance. Mortality, clinical signs, and bodyweight were recorded. At the end of the observation period, animals were sacrificed and a necropsy was performed.
No animal died as a result of the treatment with Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1). No clinical signs were observed and the animals showed the expected bodyweight increase. There was no treatment-related finding during the necropsy.
It can be concluded that the substance has a LD0 of 2,000 mg/kg bw and a LD50 above 2,000 mg/kg bw. Therefore reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) does not meet the criteria for classification in accordance with Regulation (EC) No.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.
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.