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EC number: 224-536-1 | CAS number: 4402-30-6
- 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
Acute toxicity data indicate a low toxicity: in rats the oral LD50 was 2150-3830 mg/kg bw.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented study report which meets basic scientific principles.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- BASF-Test: The study was conducted according to an internal BASF method which in principle is comparable to the OECD Guideline 401. A test group consisting of 5 animals/sex was treated by single gavage application with an aqueous solution of the test substance. The animals were observed for mortality and for clinical symptoms of toxicity. They were weighed prior treatment and thereafter, day 3, day 7 and day 13 post-treatment. At the end of the observation period of 14 days, the surviving animals were sacrificed for the purpose of necropsy; animals that died during the observations period also were subjected to necropsy.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH.
- Weight at study initiation: males: 179 - 237 g. females: 180 - 201 g.
- Fasting period before study: animals were given no feed about 16 hours before administration, but water was available ad libitum.
- Housing: Stainless steel wire mesh cages, type DK-III (Becker & Co). 5 animals per cage.
- Diet: ad libitum; Kliba-lobordiaet 343 (Klingentalmuehle AG, Switzerland).
- Water: ad libitum
- Acclimation period: at least 1 week
- Animal identification: identification of groups using cage cards
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 (animal room fully air-conditioned).
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12h/12h (6:00 - 18:00 hours / 18:00 - 6:00 hours) - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 6.81, 21.50, 38.30 and 50.00 % (w/v)
- Amount of vehicle: 10 mL/kg
- Justification for choice of vehicle: aqueous formulation corresponds to the physiological medium. - Doses:
- 681, 2150, 3830, 5000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Recording of signs and symptoms several times on the day of administration, at least once each workday. Check for moribund and dead animals twice each workday and once on holidays.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs (dyspnea, apathy, staggering, piloerection, salivation, general state), body weight, gross pathological examination. - Statistics:
- no data
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 150 - 3 830 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 681 and 2150 mg/kg bw dosing groups: no deaths occurred
3830 mg/kg bw group: 4/5 females and 5/5 males died on Day 1 after exposure
5000 mg/kg bw group: 5/5 females and 5/5 males died on Day 1 after exposure - Clinical signs:
- other: Dyspnea, apathy, staggering, piloerection, salivation, poor general state were observed in animals from dose groups 2150 mg/kg bw, and higher
- Gross pathology:
- Animals that died during the test (males and females):
- general congestion
- severe redness of forestomach, glandular stomach and small intestines
- pink colouration of the urine (at 5000 mg/kg bw)
Sacrificed animals (males + females):
- no abnormalities detected in the organs.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 150 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Oral toxicity
In an acute oral toxicity study comparable to OECD guideline 401, Wistar rats (5/sex/dose) were exposed to a single oral dose of 681 - 5000 mg/kg bw 1,1'-(methylimino)dipropan-2-ol by gavage and observed for 14 days (BASF AG, 1987). Clinical findings included dyspnoea, apathy, staggering, piloerection, salivation, poor general state and were observed in animals from dose groups 2150 mg/kg bw and higher. At pathology, general congestion, severe redness of forestomach, glandular stomach and small intestines and pink colouration of the urine (at 5000 mg/kg bw) was observed in animals that died during the test. Animals sacrificed after the observation period showed no pathological abnormalities. The LD50 was 2150-3830 mg/kg bw.
Justification for selection of acute toxicity – oral endpoint
Only study available; adverse effects were observed beyond the classification limit of 2000 mg/kg bw.
Justification for selection of acute toxicity – inhalation endpoint
In accordance with column 2 of REACH Annex VIII, further testing on acute toxicity (required in section 8.5) does not need to be conducted as the available information show that the criteria are met for classification as corrosive to the skin (R34, skin corr. cat. 1B). In conclusion, further testing is scientifically unjustified.
Justification for selection of acute toxicity – dermal endpoint
In accordance with column 2 of REACH Annex VIII, further testing on acute toxicity (required in section 8.5) does not need to be conducted as the available information show that the criteria are met for classification as corrosive to the skin (R34, skin corr. cat. 1B). In conclusion, further testing is scientifically unjustified.
Justification for classification or non-classification
Based on the results of the acute oral toxicity study, 1,1'-(methylimino)dipropan-2-ol does not need to be classified according to Directive 67/548/EEC and according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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.
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