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EC number: 231-391-8 | CAS number: 7529-22-8
- 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
Skin irritation:
Mallory VT (1981) determined in a KL 2 study the skin irritation
potential of NMMO in New Zealand White rabbits according to a method
similar to OECD Guideline 404. NMMO was observed to be slightly
irritating to the skin.
Based on the results of this study and the criteria of the CLP Regulation, the substance does not have to be classified as skin irritant.
This study was selected as key study.
Eye irritation:
Mallory VT (1981) determined in a KL 1 study the eye irritation
potential of NMMO in New Zealand White rabbits according to a method
similar to OECD Guideline 405 and EU Method B.5. NMMO was observed to be
slightly irritating to the eyes.
Based on the CLP criteria, the substance does not have to be classified as eye irritant.
This study was selected as key study.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From November 17, 1981 through November 21, 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Also abraded skin was exposed. Exposure for 24h. Occlusive dressing used.
- GLP compliance:
- yes
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 4236-43-5, Order #J-86
- Substance type: Yellow liquid
- Physical state: liquid
- Purity: responsibility of the sponsor
- Stability: There was no apparent change in the physical state of the test article during administration
- Other: pH 10.2-10.3 - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Perfection Breeders, Inc., Douglasville, Pennsylvania
- Weight at study initiation: 2 - 3 kilograms
- Housing: Separate isolation by the test system; rabbits were housed individually in cages sized in accordance with the "Guide for the Care of Laboratory Animals" of the Institute of Laboratory Resources, National Research Council.
- Diet (e.g. ad libitum): Wayne Rabbit Ration, ad libitum, checked daily and added or replaced as needed. Feeders are designed to reduce soiling, bridging, and scattering
- Water (e.g. ad libitum): Availability - fresh tap water, fit for human consumption, ad libitum, using 16 ounce glass bottles with rubber stopper and stainless steel sipper tube or an automatic watering system supplied by Edstrom Industries Inc., Waterford, Wisconsin.
- Acclimation period: five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 3°C
- Humidity (%): 30 to 70%
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark - Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL/site - Duration of treatment / exposure:
- 24 hours
- Observation period:
- Animals were observed for signs of erythema and edema and scored according to the Draize scale at 1, 24, 48 and 72 hours after application of the test material.
- Number of animals:
- Six (three males, three females)
- Details on study design:
- TEST SITE
- Area of exposure: The test article was administered at two skin sites, one abraded and one intact site.
- Type of wrap if used: Following nthe application of the test material, one-inch square gauze patches were applied to each of the two sites. The trunk of the animal was then wrapped with a rubber dam and an Ace bandage to retard evaporation.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the 24 hour exposure period, the wrappings were removed and the skin wiped to remove any remaining material. Animals were observed for signs of erythema and edema and scored according to the Draize scale at 1, 24, 48 and 72 hour after the application of the test material.
SCORING SYSTEM: Draize evaluation of dermal irritation - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- based on 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Only intact skin taken into account
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- based on 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Only intact skin taken into account
- Irritant / corrosive response data:
- Slight erythema was visible only at one hour after bandage removal in 3 animals. No edema was observed throughout the study.
- Other effects:
- No effects on body weight.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based upon the observations made in the primary dermal irritation study in rabbits, the test article was not considered to be a dermal irritant. Based on the results of this test and the criteria of the CLP Regulation, the substance should not be classified for skin irritation.
- Executive summary:
In a primary dermal irritation study performed equivalent/similar to OECD TG 404, three New Zealand White rabbits/sex were dermally exposed to 0.5 ml/site of 4-methylmorpholine 4-oxide. Test sites were covered with an occlusive dressing for 24 hours. Animals were then observed for 72 hours. Irritation was scored by the method of Draize.
Slight erythema was visible only at one hour after bandage removal in 3 animals. No edema was observed throughout the study.
In this study, the test materials is not a dermal irritant to the skin based on the lack of findings for edema and a transient observation of slight erythema.
Based on the results of this test and the criteria of the CLP Regulation, the substance should not be classified for skin irritation.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From November 17, 1981 through November 24, 1981
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 4236-43-5, Order# J-86
- Substance type: yellow liquid
- Physical state: liquid
- Purity: responsibility of the sponsor
- Stability under test conditions: There was no apparent change in physiological state of the test article during administration - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Perfection Breeders, Inc., Douglassville, Pennsylvania
- Weight at study initiation: males 2.021-2.096 kg; females 2.103-2.124 kg
- Housing: Separate isolation by test system; rabbits were housed individually in cages sized in accordance with the "Guide for the Care of Laboratory Animals" of the Institute of Laboratory Resources, National Research Council
- Diet (e.g. ad libitum): Wayne Rabbit Ration, ad libitum, checked daily and added or replaced as needed. Feeders are designed to reduce boiling, bridging, and scattering.
- Water (e.g. ad libitum): Availability - fresh tap water, fit for human consumption, ad libitum, using 16 ounce glass bottles with rubber stopper and stainless steel sipper tube or an automatic watering system supplied by Edstrom industries, Inc., Waterford, Wisconsin
- Acclimation period: five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21°C
- Humidity (%): 51-58%
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the contralateral eye remained untreated and served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- Single exposure
- Observation period (in vivo):
- The eyes were examined at 1, 24, 48 and 72 hours and 7 days after treatment.
- Number of animals or in vitro replicates:
- six animals
- Details on study design:
- SCORING SYSTEM: An animal exhibited a positive reaction when the test substance produced one or more of the following signs: ulceration of the cornea (other than a fine stippling), opacity of the cornea (other than a slight dulling of the normal luster), inflammation of the iris (other than a slight deepening of the rugae or a light hyperemia of the circumcorneal blood vessels), and obvious swelling in the conjunctivae (excluding the cornea and iris) with partial eversion of the eyelids and a diffuse crimson color with individual vessels not easily discernible.
Grading: according to the method of Draize
Classification of the test substance:
Non-irritant: 0 or 1 rabbit with positive scores
Indeterminate: 2 or 3 rabbtis with positive scores
Irritant: 4 to 6 rabbits with positive scores - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- based on 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- based on 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- based on 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.44
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- based on 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.22
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- mean
- Remarks:
- based on 6 animals
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.22
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- Five rabbits exhibited a positive response at the one hour observation period. Two rabbits exhibited a positive response at the 24 hour reading. One positive response was observed at the 48 hour reading. No positive responses were observed at 72 hour or on day 7. Eight positive responses were recorded during the course of the study.
- Other effects:
- No effects on body weight.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based upon the observations made in the Acute Eye Irritation Test in Rabbits, the substance was determined to be a mild eye irritant. Based on the CLP classification criteria, the substance does not need to be classified for eye irritation.
- Executive summary:
In a primary eye irritation study performed equivalent/similar to OECD TG 405, 0.1 ml of 4-methylmorpholine 4-oxide was instilled into the conjunctival sac of six New Zealand White rabbits. Animals were then examined at 1, 24, 48 and 72 hours and 7 days after treatment. Irritation was scored by the method of Draize.
The mean cornea opacity and iris score from the 24, 48 and 72 hours time-points were 0, based on six animals. The mean conjunctivae score for redness was 0.44 and for discharge was 0.22. The mean chemosis score was 0.22. All effects were fully reversible, as there were no positive responses observed after 72 hours or on day 7.
In this study, the test material is not an eye irritant. Based on the CLP classification criteria, the substance does not need to be classified for eye irritation.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation / corrosion:
Mallory VT (1981) studied skin irritation/corrosion by applying NMMO on one intact and one abraded site. At the end of the 24 hour exposure period, the wrappings were removed and the skin wiped to remove any remaining material. Animals were observed for signs of erythema and edema and according to the Draize scale at 1, 24, 48 and 72 hours after the application of the test material. Slight erythema was visible only at one hour after bandage removal in 3 animals. No edema was observed throughout the study. Based on the observations made in the primary dermal irritation study in rabbits, the test article was not considered to be a dermal irritant.
In a supporting KL 2 study very slight erythema was noted at one abraded site at the 24-hour reading. No other irritative or corrosive effects were noted at any time. The primary irritation index was found to be 0.04.
Based on the results of these tests and the criteria of the CLP Regulation, the substance should not be classified for skin irritation.
Eye irritation:
Mallory VT (1981) studied eye irritation by applying 0.1 mL NMMO to the eye of 6 New Zealand White rabbits. The other untreated eye served as control. The eyes were examined at 1, 24, 48 and 72 hours and 7 days after treatment. An animal exhibited a positive reaction when the test substance produced one or more of the following signs: ulceration of the cornea (other than a fine stippling), opacity of the cornea (other than a slight dulling of the normal luster), inflammation of the iris (other than a slight deepening of the rugae or a light hyperemia of the circumcorneal blood vessels), or and obvious swelling in the conjunctivae (excluding the cornea and iris) with partial eversion of the eyelids and a diffuse crimson color with individual vessels not easily discernible. Five rabbits exhibited a positive response at the one hour observation period. Two rabbits exhibited a positive response at the 24 hour reading. One positive response was observed at the 48 hour reading. No positive responses were observed at 72 hour or on day 7. Eight positive responses were recorded during the course of the study. Based upon the observations in the Acute Eye Irritation Test in Rabbits, the authors determined the substance to be a mild eye irritant. However, based on the CLP classification criteria, the substance does not need to be classified for eye irritation.
In a supporting KL study application of the substance to the eyes of New Zealand White rabbits produced conjunctival erythema in four rabbits. As no information is available on effects later than 72h, reversibility of shown effects cannot be judged.
Justification for classification or non-classification
According to the criteria of the CLP Regulation, NMMO does not have to be classified as irritating to the skin nor to the eyes.
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