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EC number: 213-635-5 | CAS number: 996-35-0
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- N,N-dimethylisopropylamine
- EC Number:
- 213-635-5
- EC Name:
- N,N-dimethylisopropylamine
- Cas Number:
- 996-35-0
- Molecular formula:
- C5H13N
- IUPAC Name:
- dimethyl(propan-2-yl)amine
- Details on test material:
- - Name of test material (as cited in study report): N,N-Dimethylisopropylamine
- Analytical purity: 99.773 %
- Lot/batch No.: B 2009 13.03.06 13:30
- Substance number: 06/0180-1
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Centre Lago S. A., 01540 Vonnas, France
- Age at study initiation: ca. 6 months
- Weight range at study initiation: 3.43 kg – 3.52 kg
- Housing: single housing
- Diet: Kliba-Labordiaet (Kaninchen & Meerschweinchenhaltung “GLP”), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland, ad libitum
- Water: Tap water ad libitum
- Acclimation period: at least 5 days before application
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 30-70%
- Air changes (per hr): The animals were housed in fully air-conditioned rooms.
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Untreated skin sites of the same animal.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The test patch (2.5 cm x 2.5 cm) was moistened with a dose of 0.5 mL of the undiluted liquid test substance. - Duration of treatment / exposure:
- 3 min
- Observation period:
- 14 days
(A check for dead or moribund animals was made twice each workday and once daily at weekends.) - Number of animals:
- 2
- Details on study design:
- TEST SITE
- Area of exposure: 2.5x2.5 cm
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test substance was removed at the end of the exposure period with Lutrol and Lutrol/water (1:1).
- Time after start of exposure: 3 min
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: corrosion
- Basis:
- mean
- Remarks:
- (2 animals)
- Remarks on result:
- other: Full thickness necrosis occurred after a 3 min exposure period.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- (2 animals)
- Time point:
- other: 24, 48 and 72 h
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (2 animals)
- Time point:
- other: 24, 48 h and 72 h
- Score:
- 2.2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
Any other information on results incl. tables
Mean erythema score after 24, 48 and 72 h; (animal1/animal2)
24 h | 48 h | 72 h | mean | ||
3 min | 3/3 | 3/4 | 3/4 | 3/3.7 |
Mean edema score after 24, 48 and 72 h; (animal1/animal2)
24 h | 48 h | 72 h | mean | ||
3 min | 2/3 | 2/2 | 2/2 | 2/2.3 |
Moderate to severe erythema (grade 2-4) and moderate to marked edema (grade 2-3), partly extended beyond the area of exposure, were observed in all animals immediately after removal of the patch up to study termination on day 14.
Additional findings like scaling, severe scaling, petechiae, eczematoid skin change and thickening of the skin at the application area were noted over the observation period. The skin of the application area appeared temporarily whitish-brownish, slightly brownish or dark brown. The cutaneous reactions were not reversible in the animals within 14 days after removal of the patch. The first animal still showed erythema, edema, severe scaling, eczematoid skin change and thickening of the skin at study termination. The skin was soft and relocatable. In the second animal erythema, edema, eczematoid skin change and thickening of the skin were noted and the skin appeared dark brown.
Pathological-anatonomical evaluation:
Animal 02 (right flank): lesion at the application area, incrusted surface.
Histopathological examination:
Animal 02 (right flank): full thickness necrosis of epidermis with severe, diffuse intraepidermal infiltration with lymphocytes, histiocytes, neutrophilic and eosionophilic granulocytes and serocellular crusts.
Major finding: Full thickness necrosis occurred after a 3 min exposure period.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (corrosive) based on GHS criteria
- Conclusions:
- Under the experimental conditions, DMIPA was considered as corrosive when applied topically to rabbits
- Executive summary:
The acute dermal irritation of N,N-dimethylisopropylamine (DMIPA) was evaluated in rabbits according to OECD 404 guideline. DMIPA was applied undiluted to the skin of 2 New-Zealand White albino rabbits and held in contact for 3 minutes by means of a semi-occlusive dressing. Mean scores over 24, 48 and 72 hours for each animal were for erythema and for oedema. Animals were then observed daily during 14 days. Moderate to severe erythema (grade 2-4) and moderate to marked oedema (grade 2-3), partly extended beyond the area of exposure, were observed in all animals immediately after removal of the patch up to study termination on day 14. Additional findings like scaling, severe scaling, petechiae, eczematoid skin change and thickening of the skin at the application area were noted over the observation period. The skin of the application area appeared temporarily whitish-brownish, slightly brownish or dark brown. The cutaneous reactions were not reversible in the animals within 14 days after removal of the patch. The first animal still showed erythema, oedema, severe scaling, eczematoid skin change and thickening of the skin at study termination. The skin was soft and relocatable. In the second animal erythema, edema, eczematoid skin change and thickening of the skin were noted and the skin appeared dark brown.
Under the experimental conditions, DMIPA was considered as corrosive when applied topically to rabbits.
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