Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 276-014-8 | CAS number: 71786-60-2
- 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
Ethanol, 2,2’-iminobis-, N-coco alkyl derives CAS No 61791-31-9 will be registered for REACH as 2, 2’-(C12-18 evennumbered alkyl imino) diethanol CAS No 71786-60-2. The only available information is on acute oral toxicity, testing by the inhalation and dermal routes is waived.
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
- Study period:
- Between 7 December 1983 and 7 January 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- GLP compliance:
- not specified
- Remarks:
- in-house quality assurance was in place
- Test type:
- up-and-down procedure
- Limit test:
- no
- Species:
- rat
- Strain:
- other: HC/CFY (remote Sprague-Dawley)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hacking and Churchill Limited, England
- Age at study initiation: 4-6 weeks
- Weight at study initiation: 80 to 129 g
- Fasting period before study: Access to food only was prevented overnight prior to and approximately 4 hours after dosing
- Housing: individually housed in metal cages with wire mesh floors
- Diet (e.g. ad libitum): ad libitum, Laboratory Diet No. 1, Spratt's Rodent Breeding Diet (LAD 1)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-23
- Humidity (%): 45
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: Between 7 December 1983 and 7 January 1984 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED:
2.9 ml/kg - Doses:
- 1.0, 1.26, 1.6, 2.0, 2.5 g/kg
- No. of animals per sex per dose:
- The study continued until 6 animals per sex had been dosed after reversal of the initial outcome; 11 males and 11 females were
used in total. - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 7 days
- Frequency of observations and weighing: twice daily observations and individual bodyweights of rats were measured on Days 1 (day of dosing), 8 and at death.
- Necropsy of survivors performed: yes
- Other examinations performed: none - Statistics:
- LD50 values were estimated by probit analysis, using a slope estimated from background data. The probit model was fitted by
maximum likelihood, with a slope of 8.333 (equivalent to a standard deviation of 0.12 units for the distribution of individual (log.)
tolerance levels). Approximate confidence intervals (95% level) were determined by adding and subtracting 1.96 times the standarderror of the (log.) LD50 estimate. - Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 700 mg/kg bw
- 95% CL:
- 1 300 - 1 600
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 300 mg/kg bw
- 95% CL:
- 1 000 - 1 600
- Mortality:
- see: remarks on results including tables and figures
- Clinical signs:
- other: Signs in all rats after dosing included piloerection, hunched posture and abnormal gait (waddling). These signs were accompanied by: lethargy, decreased respiratory rate, ptosis and pallor of the extremities amongst rats at all the dose levels, increased
- Gross pathology:
- No effects observed in survivors. Autopsy of animals that died revealed congestion of the lungs and pallor of the liver, kidneys and spleen.
- Interpretation of results:
- Category 4 based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- The acute median lethal oral doses (LD50) and their 95% confidence limits were estimated to be:
Males: 1.7 (1.3 to 2.1) g/kg bodyweight
Females: 1.3 (1.0 to 1.6) g/kq bodyweight
According to these results the substance should be classified as Category IV according to OECD-GHS. - Executive summary:
According to an up-and-down procedure male and female rats were administered a single dose of the undiluted test compound ranging from 1.0 to 2.5 g/kg bw. Clinical signs in all rats after dosing included piloerection, hunched posture and abnormal gait (waddling). These signs were accompanied by lethargy, decreased respiratory rate, ptosis and pallor of the extremities amongst rats at all the dose levels, increased salivation amongst rats dosed at 1.0, 1.26, 1.6 and 2.5 g/kg, and diarrhoea in one female rat treated at 1.26 g/kg and one male at 1.6 g/kg. Recovery of survivors as judged by external appearance and behaviour was apparently complete 5 to 7 days after dosing. Body weight of the survivors was not affected, animals that died had decreased bodyweights. Necropsy findings were normal in survivors; in non-survivors these consisted of congestion of the lungs, and pllaor of the liver, kidneys and spleen. The acute median lethal oral doses (LD50) and their 95% confidence limits were estimated to be 1.7 (1.3 to 2.1) g/kg bw for males, and 1.3 (1.0 to 1.6) g/kq bw for females. According to these results the substance should be classified as Category IV according to OECD-GHS criteria.
Reference
Mortality data
0 = survival
1 = death
mortality data on each dosing occasion | ||||||||||||
sex | dose (g/kg) | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 |
m | 1.0 | 0 | ||||||||||
m | 1.26 | 0 | 0 | 0 | ||||||||
m | 1.6 | 1 | 1 | 1 | 0 | |||||||
m | 2.0 | 1 | ||||||||||
m | 2.5 | 1 | 1 | |||||||||
f | 1.0 | 0 | 0 | 0 | ||||||||
f | 1.26 | 1 | 0 | 0 | 1 | |||||||
f | 1.6 | 1 | 1 | 1 | ||||||||
f | 2.0 | |||||||||||
f | 2.5 | 1 |
Time and number of deaths
sex | dose (g/kg) | No. of deaths | Day | ||||||||||
1 | 2 | 3 | 4 | 5 | 6 -8 | ||||||||
No. Dosed | 0.5 -6 h after dosing | a | b | a | b | a | b | a | b | a | b | ||
m | 1.0 | 0/1 | |||||||||||
m | 1.26 | 0/3 | |||||||||||
m | 1.6 | 3/4 | 2 | 1 | |||||||||
m | 2 | 1/1 | 1 | ||||||||||
m | 2.5 | 2/2 | 2 | ||||||||||
f | 1.0 | 0/3 | |||||||||||
f | 1.26 | 2/4 | 1 | 1 | |||||||||
f | 1.6 | 3/3 | 1 | 2 | |||||||||
f | 2.5 | 1/1 | 1 |
a First observation
b Second observation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 500 mg/kg bw
- Quality of whole database:
- Adequate for CLP classification and labelling.
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
There are four acute oral toxicity studies available for Ethanol, 2, 2’-iminobis-, N-coco alkyl derives CAS No 61791-31-9. There are three Klimisch 2 studies, the first study Kynock & Chanter 1984, which used the up and down procedure, estimated the acute median dose (LD50) to be 1.7 (1.3-2.1) g/kg/bodyweight for males and 1.3 (1.0-1.6) g/kg/bodyweight for females. The second study Davies and Grummant 1967 in a pre GLP study showed 50% mortality at 2ml/kg (ca. 1.8mg/kg) bodyweight based on a density of 910kg/m3. The third study Hoechst (1979) reported an oral LD50 value in females only of 1720 mg/kg.
In a fourth study Kynoch 1985, which was Klimisch 4 the LD50 was reported to be 2.1g/kg.
Based on the three Klimisch 2 studies the weight of evidence indicates and LD50 of between 1.3 and 1.8g/kg, ca. 1.5g/kg (1500mg/kg).
There is no data for acute skin toxicity, but due to the corrosive nature of the substance it is not ethical to carry out such an animal study. The corrosive classification of 2, 2’-(C12-18 evennumbered alkyl imino) diethanol CAS No 71786-60-2.and the required risk management measures will minimise the potential for skin contact, so the lack of a dermal LD50 will not affect the safe handling of the substance.
2, 2’-(C12-18 evennumbered alkyl imino) diethanol, CAS No 71786-60-2. is a liquid with a low vapour pressure 0.73mPa s at 20ºC, significant exposure to vapours would not be expected at ambient temperatures so the lack of an inhalation LD50 is not considered significant. This test is therefore waived.
Based on the viscosity being 150 mPa s at 20ºC and a density of 910kg/m3, the kinematic viscosity would be ca. 165 mm2/s. It is therefore unlikely the kinematic viscosity would be less than 20.5 mm2/s at 40ºC, therefore an aspiration hazard is not expected.
.
Justification for selection of acute toxicity – oral endpoint
Most recent study plus weight of evidence from other Klimisch 2 studies Davies & Grummant 1967 and Hoechst 1979.
Justification for selection of acute toxicity – inhalation endpoint
Due to physical properties of the substnace with its very low vapour pressure, inhalation is not expected at ambient temperatures so the lack of an inhalation LD50 is not considered significant. This test is therefore waived.
Justification for selection of acute toxicity – dermal endpoint
Due to the corrosive properties of the substance to the skin, it is not ethical on animal welfare grounds to carry out an acute dermal toxicty study. The corrosive classification of 2, 2’-(C12-18 evennumbered alkyl imino) diethanol CAS No 71786-60-2.and the required risk management measures will minimise the potential for skin contact, so the lack of a dermal LD50 will not affect the safe handling of the substance.
Justification for classification or non-classification
Based on the three Klimisch 2 rated acute oral toxicity studies on Ethanol, 2,2’-iminobis-, N-coco alkyl derives CAS No 61791-31-9, the oral LD50 value of ca, 1500mg/kg is considered correct, this leads to an EU CLP (GHS) classification as category 4 for acute oral toxicity. There is no other data to indicate a need for classification for the other routes of exposure.
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.