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Diss Factsheets
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EC number: 200-957-6 | CAS number: 76-39-1
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- Method according to Buehler
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-6 (Skin Sensitisation)
- Principles of method if other than guideline:
- The sensitization potential of test material was tested in the female guinea pig according to Buehler's procedure (Buehler, E.V. "Delayed Contact Hypersensitivity in the Guinea Pig", Arch. Dermat. 91, 171-175, 1965)
- GLP compliance:
- no
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Buehler test considered to be reliable predictor of dermal sensitization
Test material
- Reference substance name:
- 2-methyl-2-nitropropan-1-ol
- EC Number:
- 200-957-6
- EC Name:
- 2-methyl-2-nitropropan-1-ol
- Cas Number:
- 76-39-1
- Molecular formula:
- C4H9NO3
- IUPAC Name:
- 2-methyl-2-nitropropan-1-ol
- Details on test material:
- Purity is above 99%.
Constituent 1
- Specific details on test material used for the study:
- NMP Crystals, 2-nitro-2-methyl-1-propanol, 99.6% purity
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- female
- Details on test animals and environmental conditions:
- Test conducted with 30 female guinea pigs weighing 250-300 g. Group 1: ten animals treated with test material; Group 2: ten animals treated wirh positive control; Group 3: ten animals treated with negative control
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Remarks:
- Distilled water
- Concentration / amount:
- Group 1: 0.5 ml of 25% test material
- Day(s)/duration:
- 1 day (24 hours)
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Remarks:
- 5% Formaldehyde
- Concentration / amount:
- Group 2: 0.5 ml of 5% formaldehyde
- Day(s)/duration:
- 1 (24 Hours)
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Remarks:
- 1% CMC
- Concentration / amount:
- 0.5 ml of 1% CMC
- Day(s)/duration:
- 1 (24 Hours)
- Adequacy of induction:
- not specified
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Remarks:
- Distilled water
- Concentration / amount:
- 0.5 ml
- Day(s)/duration:
- 1 day
- Adequacy of challenge:
- not specified
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Remarks:
- 5% formaldehyde
- Concentration / amount:
- 0.5 ml
- Day(s)/duration:
- 1 day
- Adequacy of challenge:
- not specified
- No.:
- #3
- Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Remarks:
- 1% CMC
- Concentration / amount:
- 0.5 ml
- Day(s)/duration:
- 1 day
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 10 animals per group
- Details on study design:
- Thirty female guinea pigs weighing 250-300 g were divided into 3 groups of ten each. The animals' backs and flanks were shaved free of hair. Group 1 was treated topically with 0.5 ml of 25% test material solution in distilled water under an occulsiove patch for 24 hours. Group 2 (positive control) was similarly treated with 0.5 ml of 5% formaldehyde solution. Group 3 (negative control) was treated in the same way with 0.5 ml 1% carboxymethyl cellulose (CMC) suspension. After 24 hours the patches were removed and the sites cleaned. This procedure was repeated for each group once a week for three weeks. After the last application animals were allowed to rest for two weeks. On the first day of the third week each group of animals was challenged topically with 0.5 ml of their respective solution. In additiona the Group 3 animals were also challenged with the test material solution and the formaldehyde solution. After 24 hours of exposure the patches were removed and the sites cleaned. The animals were allowed to rest for another 24 hours and then the challennge sites were depliated with Neet. Three hours later the challenge sites were scored for inglammatory skin reactions (edema and erythema). The material is considered a sensitizer if the scores in the treatment group are greater than those of the negactive controls. The positive control group serves as an internal control for the test.
- Challenge controls:
- Positive control was 2% formaldehyde; negative control was 1% CMC
- Positive control substance(s):
- yes
- Remarks:
- 5% formaldehyde solution
Results and discussion
- Positive control results:
- Sixty percent of the positive control group showed skin reactions with 2% formaldehyde solution, an expected positive response
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- other: One reading following challenge
- Hours after challenge:
- 3
- Group:
- test chemical
- Dose level:
- 0.5 ml
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: One reading after challenge
- Hours after challenge:
- 3
- Group:
- positive control
- Dose level:
- 0.5 ml
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- other: One reading after challenge
- Hours after challenge:
- 3
- Group:
- negative control
- Dose level:
- 0.5 ml
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
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.