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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 10 October 2017 to 26 October 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
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 / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Corneas from bovine eyes were obtained from a local abattoir. The eyes were removed after slaughter, completely immersed in Hanks’ Balanced Salt Solution (containing penicillin at 100 IU/mL and streptomycin at 100 µg/mL) in a suitably sized container and transported on the same day to the testing facility.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 µL - Duration of treatment / exposure:
- Ten minutes
- Duration of post- treatment incubation (in vitro):
- Two hours
- Number of animals or in vitro replicates:
- Three corneas (triplicate)
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
Upon arrival at the test facility, the corneas were excised from the eyes and loaded onto the specifically designed holders . Both chambers of each holder were filled with pre-warmed Minimal Essential Medium (MEM), with the posterior chamber filled first, ensuring that no bubbles were formed. The holders were incubated at 32±1°C for at least 1 hour. After the incubation, the media was removed from both the anterior and posterior chambers. Fresh media was added to the posterior chamber first and then the anterior chamber (this media replacement order ensured the cornea retained its natural curvature as much as possible). The opacity of each cornea was measured using an opacitometer. Any corneas found to have scratches or increased neovascularization or an opacity of >7 opacity units when examined prior to treatment were discarded.
QUALITY CHECK OF THE ISOLATED CORNEAS
On arrival at the test facility the eyes were carefully examined for defects including increased opacity, scratches and neovascularisation. Only corneas free from such defects were used.
NUMBER OF REPLICATES
Three.
NEGATIVE CONTROL USED
0.9% sodium chloride solution
POSITIVE CONTROL USED
Dimethylformamide
APPLICATION DOSE AND EXPOSURE TIME
A volume of 750 µL of the test article (or enough test article to completely cover the cornea) was applied to each of three corneas followed by a ten minute incubation at 32±1°C
POST-INCUBATION PERIOD: Two hours
REMOVAL OF TEST SUBSTANCE
After the incubation, each cornea was washed with media containing phenol red (as a pH indicator) until this indicator showed no pH effect occurring (and demonstrating that the test article had been removed successfully). The corneas were then washed once in media without phenol red.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: opacitometer
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of spectrophotometer (OD490)
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA:
The test article is concluded as inducing serious eye damage if the IVIS is >55.
The test article is concluded as not requiring classification for eye irritation if the IVIS is ≤3.
No prediction can be made if the IVIS is >3 but ≤55.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- 20.69
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: The corneas treated with the test article were noted to be cloudy and slightly wrinkled following treatment
DEMONSTRATION OF TECHNICAL PROFICIENCY:
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Negative control yields opacity and permeability values that are less than the established upper limits for these endpoints for bovine corneas as treated at the testing facility
- Acceptance criteria met for positive control: Positive control yields an IVIS within 2 standard deviations of the historical control mean.
Any other information on results incl. tables
See attached brackground documents.
Applicant's summary and conclusion
- Interpretation of results:
- other: Inconclusive
- Conclusions:
- The test article, Reaction mass of morpholine and 6 [(p tosyl)amino]hexanoic acid, compound with morpholine (1:1) (EC 944 090 8), produced an IVIS score of 20.69 and therefore no prediction can be made in respect of it’s potential to cause eye irritation as the IVIS was >3 but <55.
- Executive summary:
An in vitro Bovine Corneal Opacity and Permeability (BCOP) assay was performed in line with OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method).
The undiluted test material was applied to three cattle corneas obtained from an abattoir at a volume of 750 μL, after which each cornea was incubated at 32 ± 1 °C for 10 minutes and then washed with phenol red-containing media followed by a media without phenol red. Corneal opacity was measured after a 2 hour period of horizontal incubation. For permeability, the corneas were incubated in the vertical position for 1 hour and 25 minutes at 32 ± 1°C within a sodium fluorescein solution. Thereafter, three 350 μL aliquots of this media (per cornea) were analysed for optical density at 490 nanometers (OD490). A positive (dimethylformamide) and negative (0.9% sodium chloride solution) control was applied using the same procedure to additional groups of corneas.
The mean corrected opacity reading for the test article, positive control, and negative control was 16.0, 62.7, and 0.0, respectively. The mean group corrected optical density for the test article was 0.180 and the mean group corrected optical density for the positive and negative control was 0.243 and 0.000, respectively. An In Vitro Irritation Score (IVIS) of 20.69 was calculated for Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) from corneal opacity and permeability measurements. No prediction can be made if the IVIS is >3 but ≤ 55 and, therefore, the study is inconclusive.
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