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Diss Factsheets
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EC number: 620-539-0 | CAS number: 1218787-30-4
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989-1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Substance: CESIO 19. No data on batch no. and composition. Basic data given; comparable to guidelines/standards. No information on concentration/dose volume
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 2,2'-(C16-18 (evennumbered) alkyl imino) diethanol
- EC Number:
- 620-539-0
- Cas Number:
- 1218787-30-4
- Molecular formula:
- No molecular formula
- IUPAC Name:
- 2,2'-(C16-18 (evennumbered) alkyl imino) diethanol
- Test material form:
- other: waxy solid
- Details on test material:
- - Chemical name: 2,2'-(C16-18 (evennumbered) alkyl imino) diethanol
- EC number: 620-539-0
To the best of knowledge, the sample used is representative to the boundary composition shared and agreed by each registrant.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Natin & Kingman Ltd., Grimston, Hull, UK
- Age at study initiation: ca. 5-8 weeks
- Weight at study initiation: 120-132 g (males), 122-136 g (females)
- Fasting period before study: overnight prior to dosing until 2-3.5 h after dosing
- Housing: 5/sex in solid floor propylene cages with sawdust bedding
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: no data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: methylcellulose (1%)
- Details on oral exposure:
- VEHICLE
- 1% methylcellulose
- Concentration in vehicle: not indicated
- Amount of vehicle (if gavage): not indicated
- Justification for choice of vehicle: not indicated
MAXIMUM DOSE VOLUME APPLIED: not indicated, based on fasted bw at the time of dosing - Doses:
- 25, 200, 2000, 5000 mg/kg bw (range-finding study)
2000 mg/kg bw (main study) - No. of animals per sex per dose:
- 1/sex (range-finding study): 8 in total
5/sex (main study): 10 in total - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days (5 days in rang-finding study)
- Frequency of observations and weighing: 1 and 4 h after dosing, once daily therafter. BW weekly
- Necropsy of survivors performed: yes (not on animals of the range-finding study) - Statistics:
- Not required.
Results and discussion
- Preliminary study:
- 1 out of 2 animals died at 5000 mg/kg bw (range-finding study); therefore 2000 mg/kg bw was chosen as target level in main study.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: 1/5 females was found dead
- Mortality:
- One female was found dead 2 days after treatment.
- Clinical signs:
- other: All animals showed hunched posture and pilo-erection 1 and 4 h after treatment.
- Gross pathology:
- Necropsy findings in the deceased animal consisted of abnormally red lungs, dark liver and kidneys and haemorrhage of the gastric mucosa. No abnormalities were noted in survivors.
- Other findings:
- No.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- The oral LD50 is larger than 2000 mg/kg bw. However, based on 10% mortality at this level and 1/2 rats dying at 5000 mg/kg bw
(range-finding study), the LD50 is expected to be close to 5000 mg/kg bw. Therefore classification in Category V, according to
OECD-GHS criteria. - Executive summary:
The study was performed to assess the acute toxicity of the test material following a single oral administration to the Sprague-Dawley strain rat. The study was performed according to OECD guideline 401. Following a range-finding study, a group of ten fasted animals (five male and five female) was given a single, oral dose of the test material at a dose level 2000 mg/kg bodyweight. The animals were observed for 14 days after the day of dosing and were then killed for gross pathological examination. One female was found dead 2 days after dosing. Clinical signs of toxicity noted were hunched posture and pilo-erection 1 and 4 h after dosing. Most survivors showed expected gains in bodyweight over the study period; in 2 female rats bw gain was reduced or slight body weight loss was observed. No abnormalities were noted in survivors at necropsy; the deceased animal showed abnormally red lungs, dark liver and kidneys and haemorrhage of the gastric mucosa. The acute median lethal dose (LD50) of the test material was found to be greater than 2000 mg/kg bodyweight. The test material was considered not to have significant acute toxicity and does require classification in Category V, according to OECD-GHS (based on 10% mortality at 2000 mg/kg bw and 1/2 dead animals at 5000 mg/kg bw).
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.
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