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EC number: 212-828-1 | CAS number: 872-50-4
- 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
Based on key study results and according to the harmonised classification (Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation)), NMP is considered to be irritating to the skin, the eyes and the respiratory system.
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
- 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:
- not applicable
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- - Source: GAF Chemicals Corporation, Wayne, NJ, USA
- Purity: >= 98%, with less than 0.5% of water - Species:
- rabbit
- Strain:
- other: albino
- Type of coverage:
- occlusive
- Preparation of test site:
- abraded
- Remarks:
- back on one side abraded using a sterile 22-gauge needle
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: Skin of the back
- Type of wrap if used: gauze pad secured with an adhesive tape, covered with occlusive wrap
REMOVAL OF TEST SUBSTANCE
- Washing: water moistened towel, skin wiped afterwards
- Time after start of exposure: 24 hours
SCORING SYSTEM: according to Draize (Draize et al. 1944) - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24 and 72 hours
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: abraded or intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24 and 72 hours
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: abraded or intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24 and 72 hours
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: abraded or intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: 24 and 72 hours
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: abraded or intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- other: 24 and 72 hours
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: abraded or intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- other: 24 and 72 hours
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: abraded or intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: abraded or intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: abraded or intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: abraded or intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: abraded or intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- other: 24 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: abraded or intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- other: 24 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: abraded or intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- other: 24 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: abraded or intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: abraded or intact skin
- Irritant / corrosive response data:
- Effects ranged fom none to barely perceptible erythema without oedema clearing within 72 hours.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The dermal response was rated as minimal.
- Executive summary:
In a primary dermal irritation study albino rabbits were dermally exposed to undiluted NMP similar to OECD guideline 404.
Approximately 0.5 mL NMP was applied to the backs of 6 rabbits that had been closely abraded. The undiluted NMP was applied to the intact (concurrent control) and abraded skin. When the examination was repeated 72 hours after the start of exposure, no effects were observed. The tests showed a low potential for skin irritation and resulted (for both intact and abraded skin and averaged reading from 24 and 72 hours) in a primary irritation index (PII) of 0.5.
The dermal response was rated as minimal. Although the results of this study will not lead to classification, the EU has classified NMP as irritating the skin.
Reference
Rabbit |
Skin |
24 hours |
72 hours |
7 days |
|||
|
|
Erythema |
Oedema |
Erythema |
Oedema |
Erythema |
Oedema |
1 |
I |
1 |
0 |
0 |
0 |
0 |
0 |
|
I |
1 |
0 |
0 |
0 |
0 |
0 |
|
A |
1 |
0 |
0 |
0 |
0 |
0 |
|
A |
1 |
0 |
0 |
0 |
0 |
0 |
2 |
I |
1 |
0 |
0 |
0 |
0 |
0 |
|
I |
1 |
0 |
0 |
0 |
0 |
0 |
|
A |
1 |
0 |
0 |
0 |
0 |
0 |
|
A |
1 |
0 |
0 |
0 |
0 |
0 |
3 |
I |
1 |
0 |
0 |
0 |
0 |
0 |
|
I |
1 |
0 |
0 |
0 |
0 |
0 |
|
A |
1 |
0 |
0 |
0 |
0 |
0 |
|
A |
1 |
0 |
0 |
0 |
0 |
0 |
4 |
I |
1 |
0 |
0 |
0 |
0 |
0 |
|
I |
1 |
0 |
0 |
0 |
0 |
0 |
|
A |
1 |
0 |
0 |
0 |
0 |
0 |
|
A |
1 |
0 |
0 |
0 |
0 |
0 |
5 |
I |
1 |
0 |
0 |
0 |
0 |
0 |
|
I |
1 |
0 |
0 |
0 |
0 |
0 |
|
A |
1 |
0 |
0 |
0 |
0 |
0 |
|
A |
1 |
0 |
0 |
0 |
0 |
0 |
6 |
I |
1 |
0 |
0 |
0 |
0 |
0 |
|
I |
1 |
0 |
0 |
0 |
0 |
0 |
|
A |
1 |
0 |
0 |
0 |
0 |
0 |
|
A |
1 |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
|
|
|
Mean |
I |
1.0 |
0 |
0 |
0 |
0 |
0 |
|
A |
1.0 |
0 |
0 |
0 |
0 |
0 |
A: abraded skin, I: intact skin
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not applicable
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- - Source: GAF Chemicals Corporation, Wayne, NJ, USA
- Purity: >= 98%, with less than 0.5% of water - Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL - Duration of treatment / exposure:
- - treatment during complete period as single intraocular application
- additional animals treated for only 30 seconds (eye washed afterwards) - Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- Not specified
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: not specified, in additional animals
- Time after start of exposure: 30 s
SCORING SYSTEM: Draize method (Draize et al., 1944) - Irritation parameter:
- overall irritation score
- Remarks:
- Primary irritation index
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 41
- Max. score:
- 110
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: unwashed
- Irritation parameter:
- overall irritation score
- Remarks:
- Primary irritation index
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 40
- Max. score:
- 110
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: unwashed
- Irritation parameter:
- overall irritation score
- Remarks:
- Primary irritation index
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 34
- Max. score:
- 110
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: unwashed
- Irritation parameter:
- overall irritation score
- Remarks:
- Primary irritation index
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 8
- Max. score:
- 110
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: unwashed
- Irritation parameter:
- overall irritation score
- Remarks:
- Primary irritation index
- Basis:
- mean
- Time point:
- 14 d
- Score:
- 4
- Max. score:
- 110
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: unwashed
- Irritation parameter:
- overall irritation score
- Remarks:
- Primary irritation index
- Basis:
- mean
- Time point:
- 21 d
- Score:
- 0
- Max. score:
- 110
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: unwashed
- Irritation parameter:
- overall irritation score
- Remarks:
- Primary irritation index
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 35
- Max. score:
- 110
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: washed (30 sec after administration)
- Irritation parameter:
- overall irritation score
- Remarks:
- Primary irritation index
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 26
- Max. score:
- 110
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: washed (30 sec after administration)
- Irritation parameter:
- overall irritation score
- Remarks:
- Primary irritation index
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 18
- Max. score:
- 110
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: washed (30 sec after administration)
- Irritation parameter:
- overall irritation score
- Remarks:
- Primary irritation index
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 1
- Max. score:
- 110
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: washed (30 sec after administration)
- Irritation parameter:
- overall irritation score
- Remarks:
- Primary irritation index
- Basis:
- mean
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 110
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: washed (30 sec after administration)
- Irritation parameter:
- overall irritation score
- Remarks:
- Primary irritation index
- Basis:
- mean
- Time point:
- 21 d
- Score:
- 0
- Max. score:
- 110
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: washed (30 sec after administration). Value was not measured
- Irritant / corrosive response data:
- All the animals showed corneal involvement reversing within 14 days for unwashed eyes and within 7 days for washed eyes. Conjunctival effects cleared in unwashed eyes by the end of the 21-day observation period and in washed eyes by day 14.
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Remarks:
- Moderate ocular effects observed according to the Draize score system.
- Conclusions:
- Corneal effects were reversible within 14 days for unwashed eyes and within 7 days for washed eyes. Conjunctival effects cleared in unwashed eyes by the end of the 21 -day observation period and in washed eyes by day 14.
- Executive summary:
In an irritation study, New Zealand White rabbits received a single intraocular application of 0.1 mL neat NMP into the conjunctival sac of one eye, the other served as untreated control. Additional animals were dosed but their eyes were washed out 30 seconds after administration. Animals were observed for 21 days. Irritation was scored according to the method of Draize. Corneal effects were reversible within 14 days for unwashed eyes and within 7 days for washed eyes. Conjunctival effects cleared in unwashed eyes by the end of the 21 -day observation period and in washed eyes by day 14. The ocular effects were rated as moderate.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
In a primary dermal irritation study, albino rabbits were dermally exposed to undiluted NMP similar to OECD guideline 404. Approximately 0.5 mL NMP was applied to the backs of 6 rabbits that had been closely abraded. The undiluted NMP was applied to the intact (concurrent control) and abraded skin. When the examination was repeated 72 hours after the start of exposure, no effects were observed. The tests showed a low potential for skin irritation and resulted (for both intact and abraded skin and averaged reading from 24 and 72 hours) in a primary irritation index (PII) of 0.5 (Ansell & Fowler, 1988).
In a primary ocular irritation study equivalent to OECD guideline 405, New Zealand White rabbits received a single intraocular application of 0.1 mL neat NMP into the conjunctival sac of one eye. The other eye served as untreated control. Additional animals were dosed but their eyes were washed out 30 seconds after administration. Animals were observed for 21 days. Irritation was scored according to the method of Draize. Corneal effects were reversible within 14 days for unwashed eyes and within 7 days for washed eyes. Conjunctival effects cleared in unwashed eyes by the end of the 21 -day observation period and in washed eyes by day 14. The ocular effects were rated as moderate (Ansell & Fowler, 1988).
Besides, human data are available resulting from both, epidemiological and controlled human exposure studies. The conflicting results of these studies force regulators to set the risk assessment based on the most clear relevance for workplaces. A controlled human exposure study (van Thriel et al., 2007; Bader et al., 2007) with participating young volunteers, addressing peak exposures and physical and mental work, described no adverse sensory irritation for concentrations up to 160 mg/m3.
Driven by the harmonised classification (Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation)), based mainly on human occupational observations, NMP is considered to elicit irritation to the skin and the eyes.
Justification for classification or non-classification
The available experimental test data are reliable. Based on these results and according to the harmonised classification (Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation)), NMP is considered to be irritating to skin, eyes and the respiratory system as follows:
Category 2, H315, causes skin irritation
Category 2, H319, causes serious eye irritation
STOT SE 3, H335, may cause respiratory irritation.
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