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EC number: 258-061-6 | CAS number: 52636-67-6
- 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 vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2012-10-09 until 2012-10-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 24 April 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 30 May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- August 1998
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Morpholinium sulphamate
- EC Number:
- 258-061-6
- EC Name:
- Morpholinium sulphamate
- Cas Number:
- 52636-67-6
- Molecular formula:
- C4H9NO.H3NO3S
- IUPAC Name:
- morpholin-4-ium sulfamate
- Test material form:
- solid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: S & K LAP Kft. 2173 Kartal, Császár út 135, Hungary
- Age at study initiation: young adult male rabbits
- Weight at study initiation: 2834-3195 g
- Weight at end of study: 3077-3195
- Housing: Animals were housed individually in metal cages.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 18 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3°C
- Humidity: 30 - 70 %
- Air changes (per hr): 9-12
- Photoperiod (hrs dark / hrs light): 12 hours artificial light, from 6 a.m. to 6 p.m.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- A weight of 0.1 g of the undiluted and well grinded test item morpholinium sulphamate was used for the study in a single dose.
- Duration of treatment / exposure:
- The eyes of the test animals were not washed out after the application of test item.
- Observation period (in vivo):
- The eyes were examined at 1, 24, 48 and 72 hour(s) and then at 1 and 2 weeks after the application.
- Number of animals or in vitro replicates:
- 3 male animals
- Details on study design:
- SCORING SYSTEM: The eye irritation scores were evaluated according to the scoring system by Draize (1979) and OECD 405 (24 April 2002)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 1 week
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 1 week
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 1 week
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 1 week
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 1 week
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 1 week
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 1 week
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 1 week
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 1 week
- Irritant / corrosive response data:
- The eyes were examined at 1, 24, 48 and 72 hours then 1 week after the application.
One hour after treatment, some hyperemic blood vessels (score 1) were observed in two animals and diffuse, crimson coloured conjunctivae with not easily discernible individual vessels (score 2) occurred in one animal. The obvious swelling with partial eversion of lids (score 2) was detected in one animal and the conjunctival swelling with lids about half closed (score 3) was detected in two animals. The discharge with moistening of the lids and hairs just adjacent to lids (score 2) were observed in two animals and the discharge moistened lids and hairs on considerable area around the treated eye (score 3) was recorded in one animal.
24 hours after treatment, some hyperemic blood vessels (score 1) were observed in two animals and diffuse, crimson coloured conjunctivae with not easily discernible individual vessels (score 2) occurred in one animal. The obvious swelling with partial eversion of lids (score 2) was detected in all animals. The discharge with moistening of the lids and hairs just adjacent to lids (score 2) were observed in two animals and the amount of the discharge was different from normal (score 1) in one animal.
48 hours after treatment, some hyperemic blood vessels (score 1) were observed in all animals. The swelling was different from normal (score 1) in all animals and the amount of the discharge was different from normal (score 1) in two animals.
72 hours after the treatment, some hyperemic blood vessels (score 1) were observed in all animals and the swelling was different from normal (score 1) in one animal.
1 week after the treatment the study was terminated, since no primary irritation symptoms occurred.
During the study the control eyes of the animals were symptom-free.
General state and the behaviour of the animals were normal throughout the study period. There were no effects on body weight attributable to the treatment with the test item during the contact and observation period.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In conclusion, test item morpholinium sulphamate applied to the rabbits' eye mucosa, caused slight to severe irritation effects on the conjunctiva within one hour after test item administration. The condition of the conjunctiva improved within 24 hours (slight to moderate effects) and 72 hours (slight effects) and the observed effects were fully reversible within 1 week.
- Executive summary:
The acute eye irritation study of the test item morpholinium sulphamate was performed in three New Zealand White rabbits. The irritation effect of the test item was evaluated according to the method by Draize (1979) and OECD No.: 405, 2002. The test item was placed into the conjunctival sac of the left eye of each animal. The untreated right eye served as control. A weight of 0.1 g of the test item was used in well grinded state, as a single dose. The eyes of the test animals were not washed out after the application of test item. The eyes were examined at 1, 24, 48 and 72 hours then 1 week after the application. One hour after the treatment, slight to moderate conjunctival redness, moderate to severe chemosis and moderate to severe discharge were observed. 48 hours after the treatment, slight redness, chemosis and discharge were recorded. 1 week after the treatment, all animals became free of symptoms. 1 week after treatment the study was terminated, as all animals were free of symptoms of irritation.
The animals’ mean scores (considering readings at 24, 48 and 72 hours after the treatment) were as follows:
cornea opacity: 0.00, 0.00, 0.00
iris: 0.00, 0.00, 0.00
redness: 1.00, 1.33, 1.00
chemosis: 1.00, 1.00, 1.33
discharge: 1.00, 1.00, 0.33
In conclusion, test item morpholinium sulphamate applied to the rabbits' eye mucosa, caused slight to severe irritation effects on the conjunctiva within one hour after test item administration. The condition of the conjunctiva improved within 24 hours (slight to moderate effects) and 72 hours (slight effects) and the observed effects were fully reversible within 1 week. According to CLP criteria for classification and labelling requirements for dangerous substances and preparations, the test item does not have to be classified and has no obligatory labelling requirement for eye irritation. According to Regulation (EC) No 1272/2008, the test item has not been classified into any category.
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