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EC number: 263-171-2 | CAS number: 61791-39-7
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was performed between 23 march 2000 and 11 April 2000.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 1H-Imidazole-1-ethanol, 4,5-dihydro-, 2-nortall-oil alkyl derivs.
- EC Number:
- 263-171-2
- EC Name:
- 1H-Imidazole-1-ethanol, 4,5-dihydro-, 2-nortall-oil alkyl derivs.
- Cas Number:
- 61791-39-7
- Molecular formula:
- Not applicable (a generic molecular formula cannot be provided for this specific UVCB substance).
- IUPAC Name:
- 2-{2-[(8Z)-heptadec-8-en-1-yl]-4,5-dihydro-1H-imidazol-1-yl}ethan-1-ol; 2-{2-[(8Z)-heptadec-8-en-1-yl]-4,5-dihydro-1H-imidazol-1-yl}ethyl (9Z)-octadec-9-enoate
- Details on test material:
- Sponsor's identification: PR 9061
Date received: 3 March 2000
Description: light amber liquid
Storage conditions: room temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Male and female Sprague-Dawley CD (Cri : CD ® (SD) IGS BR) strain rats supplied by Charles River (UK) Ltd, Margate, Kent, UK were used. At the start
of the study the males weighed 201 to 211 g, and the females 223 to 231 g, and were eight to twelve weeks old. After an acclimatisation period of at least five days the animals were selected at random and given a number unique within the cage by taiI marking.
The animals were housed in groups of three by sex in solid-floor polypropylene cages furnished with woodflakes. With the exception of an overnight fast immediately before dosing and for approximately three to four hours after dosing, free access to mains drinking water and food (Rat and
Mouse Expanded Diet No.1, Special Diets Services limited, Witham, Essex, UK) was allowed throughout the study.
The temperature and relative humidity were set to achieve limits of 19 to 25°C and 30 to 70% respectively. Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study. The rate of air exchange was approximately fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light and twelve hours darkness.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 2.15 mL/kg
CLASS METHOD
- Rationale for the selection of the starting dose: The information available suggested a starting dose of 2000 mg/kg. - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 3 animals of each sex per dose
- Control animals:
- no
- Details on study design:
- All animals were dosed once only by gavage, using a metal cannula attached to a graduated syringe. The volume administered to each animal was
calculated according to the fasted bodyweight at the time of dosing. Treatment of animals was sequential. Sufficient time was allowed between each sex to confirm the survival of the previously dosed animals.
The animals were observed for deaths or overt signs of toxicity 1/2, 1, 2 and 4 hours after dosing and subsequently once daiIy for up to fourteen days.
Individual bodyweights were recorded prior to dosing and seven and fourteen days after treatment or at death.
At the end of the observation period the surviving animals were killed by cervical dislocation. All animals were subjected to gross pathological examination. This consisted of an external examination and opening of the abdominal and thoracic cavities for examination of major organs. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.
Results and discussion
- Preliminary study:
- Not applicable.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 500 mg/kg bw
- Remarks on result:
- other: Mortalities were noted at 2000 mg/kg bodyweight.
- Mortality:
- Individual mortality data are given in Table 1 (attached background material).
One female was killed in extremis two days after dosing. - Clinical signs:
- other: Individual clinical observations are given in Tables 2 and 3 (see attached background material). Clinical signs of toxicity commonly noted were hunched posture, lethargy, pi lo-erection and decreased respiratory rate with additional incidents of emaciatio
- Gross pathology:
- Individual necropsy findings are given in Tables 6 and 7 (see atttached background material).
Abnormalities noted at necropsy of the female that died during the study were haemorrhage and sloughing of the gastric mucosa, sloughing of the nonglandular epithelium of the stomach and haemorrhage of the small and large intestines. Abnormalities noted at necropsy of males that were killed at the end of the study were stomach adhered to the liver and/or white foci present over all of the non-glandular epithelium of the stomach. No abnormalities were noted at necropsy of females that were killed at the end of the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose (LD50) of the test material, in the Sprague Dawley CD strain rat was estimated to be greater than 2500 mg/kg bodyweight.
Mortalities were noted at 2000 mg/kg bodyweight. - Executive summary:
A study was performed to assess the acute oral toxicity of the test material following a single oral administration to the Sprague-Dawley CD strain rat. The method followed that in the OECD Guidelines for Testing of Chemicals No. 423 "Acute Oral Toxicity - Acute Toxic Class Method" (adopted 22 March 1996) and Method B1 tris of Commission Directive 96/54/EC (which constitutes Annex V of Council Directive 67/548/EEC) .
Using all available information, 2000 mg/kg bodyweight was selected as the starting dose.
A group of three fasted females was treated with the starting dose. This was followed by a group of three fasted animals of the other sex at the same dose level.
The undiluted test material was administered orally. The animals were observed 1/2, 1, 2 and 4 hours after dosing and then once daily for up to fourteen days. Bodyweights were recorded on Day 0 (day of dosing) and on Days 7 and 14, or at death. At the end of the observation period the surviving animals were killed by cervical dislocation and all animals were subjected to gross necropsy.
One female was killed in extremis two days after dosing.
Clinical signs of toxicity commonly noted were hunched posture, lethargy, piloerection and decreased respiratory rate with additional incidents of emaciation, diarrhoea, dehydration, ptosis, gasping, laboured and noisy respiration and staining around the eyes, mouth and snout. Surviving animals recovered four to seven days after dosing.
The surviving animals showed expected gains in bodyweight over the study period except for one female which showed slight bodyweight loss during the first week and expected gain in bodyweight during the second week of the study.
Abnormalities noted at necropsy of the female that died during the study were haemorrhage and sloughing of the gastric mucosa, sloughing of the non-glandular epithelium of the stomach and haemorrhage of the small and large intestines. Abnormalities noted at necropsy of males that were killed at the end of the study were stomach adhered to the liver and/or white foci present over all of the non-glandular epithelium of the stomach. No abnormalities were noted at necropsy of females that were killed at the end of the study.
The acute oral median lethal dose, (LD50) of the test material, in the Sprague-Dawley CD strain rat, was estimated as being greater than 2500 mg/kg bodyweight. Mortalities were noted at a dose level of 2000 mg/kg bodyweight.
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