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EC number: 203-556-4 | CAS number: 108-16-7
- 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
Dimemethylisopropanolamine was found to be corrosive to the rabbit skin under occlusive conditions (comparable to OECD guideline 404, non-GLP). Dermal application for 5 min caused redness, scaling and necrosis, while at 15-minutes and 20-hour exposures severe necrosis was observed which was not fully reversible within 8 days.
Single application of undiluted test substance to the rabbit eye caused severe chemical burns on the eye (comparable to OECD guideline 405, non-GLP). Severe corneal opacity was observed throughout the study and was not reversible within 8 days.
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:
- other: Meets generally accepted scientific standards, well documented and acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- Method: BASF-Test: Animals were treated for 1, 5, 15 min and 20 hours using occlusive conditions. An application site of 2.5x2.5 cm was covered with the liquid test substance. After the application time (1, 5 and 15 min) the skin was washed with Lutrol (50%). The animals were observed for 8 days and skin changes were recorded daily. The report describes findings after 24 hours and at the end of the observation period (8 days). For a final evaluation, the findings after 48 h and 72 h from the raw data were taken into account.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: ca. 2.32 kg - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): ca. 0.5 g - Duration of treatment / exposure:
- 1, 5 and 15 minutes and 20 hours
- Observation period:
- 8 days
- Number of animals:
- 2 per exposure duration
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
REMOVAL OF TEST SUBSTANCE
Washing might have been done with Lutrol and Lutrol/Water (50%/50%) at the end of the treatment (1, 5 and 15 minutes, 20 hours)
SCORING SYSTEM:
Similar to the one described in OECD 404 guideline - Irritation parameter:
- erythema score
- Remarks:
- 1 min exposure
- Basis:
- mean
- Time point:
- other: 24 h - 8 d
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: redness and scaling
- Irritation parameter:
- erythema score
- Remarks:
- 5 min exposure
- Basis:
- mean
- Time point:
- other: 24 h - 8 d
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: redness, necrosis and scaling
- Irritation parameter:
- erythema score
- Remarks:
- 15 min exposure
- Basis:
- mean
- Time point:
- other: 24 h - 8 d
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: redness and severe necrosis
- Irritation parameter:
- erythema score
- Remarks:
- 20 h exposure
- Basis:
- mean
- Time point:
- other: 24 h - 8 d
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: redness and severe necrosis
- Irritation parameter:
- edema score
- Remarks:
- 1, 5, 15 min exposure
- Basis:
- mean
- Time point:
- other: 24 h - 8 d
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Remarks:
- 20 h exposure
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritant / corrosive response data:
- Full thickness necrosis of the skin was observed in animals when exposed to the test substance for 20 hours under occlusive conditions. In addition full thickness necrosis was observed in rabbits at the end of the observation period (8 days) when exposed to the test substance for 5 or 15 minutes under occlusive conditions. Exposure for 1 minute did not lead to necrosis.
- Interpretation of results:
- corrosive
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
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:
- other: Meets generally accepted scientific standards, well documented and acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- Method: BASF-Test: 50 µL of the test substance were applied to the conjunctival sac of one eye in 2 animals. The animals were observed after 10 min, 1 and 3h on the day of treatment and up to 8 days afterwards. Findings were recorded daily. The eyes were not washed out after 24 hours as specified in OECD Guideline 405. The report describes findings after 1 and 24 hours and at the end of the observation period. For final evaluation, the findings after 48 and 72 hours from the raw data were taken into account.
- GLP compliance:
- no
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Dimethyl-isopropanolamin
- Physical state: liquid
no further data - Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: mean ca. 2.38 kg
ENVIRONMENTAL CONDITIONS
no data - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: 1 drop of 85% NaCl solution in the left eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.05 ml - Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM:
similar to the one described in OECD guideline 405 - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1 h - 24 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 8 d
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: staphyloma formation and severe necrosis
- Irritation parameter:
- conjunctivae score
- Basis:
- other:
- Time point:
- other: 1 h - 24 h
- Remarks on result:
- other: further scoring not possible due to brownish crustation
- Irritant / corrosive response data:
- Application of the test substance led to severe chemical burns on the eye. Corneal opacity grade 3-4 was observed throughout the study and was not reversible within 8 days.
- Interpretation of results:
- corrosive
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In a skin irritation test comparable to OECD guideline 404, dimemethylisopropanolamine was applied undiluted to the skin of Vienna White rabbits for 1, 5, 15 minutes or 20 hours under occlusive conditions (BASF AG, 1964). Observations took place at 24 hours and 8 days. Application for 1 minute caused redness and scaling. In animals exposed to the test substance for 5 and 15 minutes and 20 hours full thickness necrosis was observed that remained visible until the end of the observation period. Dimemethylisopropanolamine was judged corrosive to skin.
In an eye irritation test comparable to OECD guideline 405, 50 µL of the test substance was applied to the conjunctival sac of the eyes of 2 Vienna White rabbits (BASF AG, 1964). Animals were observed after 10 min, 1 and 3h on the day of treatment and at up to 8 days after the treatment. Application of the test substance led to severe chemical burns on the eye. Severe corneal opacity was observed throughout the study and was not reversible within 8 days. Dimemethylisopropanolamine was judged corrosive to eyes.
Justification for classification or non-classification
- Skin Corr. 1B (H314: Causes severe skin burns and eye damage).
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is considered to be classified for Skin Corr. 1B (H314: Causes severe skin burns and eye damage) and Eye Damage 1 (H318: Causes serious eye damage) under Regulation (EC) No. 1272/2008, as amended for the thirteenth time in Regulation (EU) No 2017/776.
Furthermore, 1-(dimethylamino)propan-2-ol is included in Annex VI of Regulation (EC) No. 1272/2008 with the following legal classification:
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