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EC number: 263-233-9 | CAS number: 61800-40-6
- 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
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January 22, 2015 - February 23, 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 436 (Acute Inhalation 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:
- hydrogenation products of (esterification products of 2-ethylhexan-1-ol with (Estolide formation products of oleic acid and Fatty acids, C8-18 and C18-unsatd. (branched or linear))
- IUPAC Name:
- hydrogenation products of (esterification products of 2-ethylhexan-1-ol with (Estolide formation products of oleic acid and Fatty acids, C8-18 and C18-unsatd. (branched or linear))
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Rat (Rattus norvegicus) / CD / Crl: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Species / Strain / Stock:
Rat (Rattus norvegicus) / CD / Crl: CD(SD)
Breeder:
Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
Age(at start of administration):
Males: approx. 8 weeks
Females: approx. 9 weeks
Body weight(at start of administration):
Males: 247 - 258 g
Females: 228 - 250 g
Selection of species:
In accordance with OECD 436, the rat is the preferred species.
Identification of animals:
By coloured marks and cage label
Group / Number of animals:
One concentration of 3 males and 3 females (limit test)
Satellite animals forinterim necropsy(24-hour sacrifice):
3 males and 3 females
Concentrations:
5.07 mg/L air (limit test) for 4 hours and 5.06 mg/L air (satellite animals) for 4 hours
Duration of experiment:
At least 5 adaptation days
1 test day
2 recovery weeks (limit test)
The females were nulliparous and non-pregnant.
The animals were randomised before use. They were acclimatised to the test apparatus for approx. 1 hour on 2 days prior to testing. The restraining tubes did not impose undue physical, thermal or immobilization stress on the animals.
Diet
Commercial diet, ssniff® R/M-H V1534 served as food. Feeding was discontinued approx. 16 hours before exposure; only tap water was then available ad libitum.
Periodic analysis of the food for contaminants based on EPA/USA is conducted at least twice a year by LUFA-ITL.
Housing
Granulated textured wood was used as bedding material for the cages. The cages were changed and cleaned twice a week.
Periodic analysis of the bedding material for contaminants based on EPA/USA is conducted at least once a year by LUFA-ITL.
During the 14-day observation period, the animals are kept by sex in groups of 3 animals in MAKROLON cages (type III plus) at a room temperature of 22°C±3°C (maximum range) and a relative humidity of 55%±15% (maximum range). Deviations from the maximum range caused for example during cleaning procedures are dealt with in SOPs.
The rooms were lit (about 150 lux at approx. 1.50 m room height) and darkened for periods of 12 hours each.
Drinking water
Drinking water in bottles was offered ad libitum.
Drinking water was examined according to the 'Deutsche Trinkwasserverordnung 2011' [German Regulations on drinking water 2011] by the Hamburger Wasserwerke, 20539 Hamburg, Germany, at least four times a year.
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose/head only
- Vehicle:
- air
- Mass median aerodynamic diameter (MMAD):
- 2.488 µm
- Geometric standard deviation (GSD):
- 2.97
- Remark on MMAD/GSD:
- The particle size distribution was analysed using a cascade impactor. The Mass Median Aerodynamic Diameter (MMAD) was determined as 2.488 µm (14-day sacrifice) or 2.460 µm (24-hour sacrifice). The Geometric Standard Deviations (GSD)
of the MMAD were calculated as 2.97 (main study, 14-day sacrifice) or 2.96 (satellite animals, 24-hour sacrifice). - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 5.07 mg/L air (limit test) for 4 hours and 5.06 mg/L air (satellite animals) for 4 hours
- No. of animals per sex per dose:
- 3 males and 3 females
- Control animals:
- yes
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.07 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- No animal died prematurely.
- Clinical signs:
- other: Under the present test conditions, a 4-hour inhalation exposure to SE7B at a concentration of 5.07 mg/L air revealed slightly reduced motility and slight ataxia on test day 1 immediately after the end of exposure until 60 minutes post exposure, slight to
- Body weight:
- No influence on body weight gain was observed.
- Gross pathology:
- Macroscopic changes in the nasal cavity and lungs
Oedematous or oedematous and marbled lungs were observed in all animals of the main study (14-day sacrifice) and in all satellite animals (24-hour sacrifice).
Microscopic changes in the nasal cavity and lungs
Test item-related histopathological changes
The histomorphological examination of the organs (trachea, larynx, lungs and nose) from the acute inhalation toxicity study of SE7B in male and female rats of the satellite rats (24-hour sacrifice) and the main study animals (14 days recovery) did not reveal any morphological lesions which are considered to be test item-related.
Not test item-related histopathological changes
Satellite animals (24-hour sacrifice) and main study animals (14-day sacrifice):
• Nose (five levels):
The nasal cavity of level 1 to 5 revealed a normal squamous epithelium and a normal respiratory epithelium. The normal respiratory epithelium partially containing cilia consisted of three major cell types: the basal cells above the basement membrane, the ciliated epithelial and the secretory goblet cells.
Some rats showed in the respiratory epithelium minimal to mild subepithelial lympho-histiocytic infiltrations or lymphocytic follicles for nose levels 3 to 5.
In all animals a normal olfactory epithelium with 5 to 7 nuclear layers, normal basal cells, olfactory sensory cells and sustentacular cells were observed for nose levels 3 to 5.
There were no morphological differences between the satellite and main study animals.
• Lungs (five levels):
All 5 lung localizations revealed a normal lung structure. A minimal to mild congestion and in one rat a minimal foamy macrophages are coincidental findings and thus are not test item-related.
The trachea of some male and female animals revealed a focal minimal to mild subepithelial lymphoid hyperplasia with normal epithelial cells. The epithelium of the larynx was normal.
There were no morphological differences between satellite and main study animals. - Other findings:
- The gravimetric aerosol concentrations of 5.07±0.02 mg (14-day sacrifice) and 5.06±0.02 mg (24-hour sacrifice) SE7B/L air were measured at the animal’s nose.
The particle size distribution was analysed using a cascade impactor. The Mass Median Aerodynamic Diameter (MMAD) was determined as 2.488 μm (14-day sacrifice) or 2.460 μm (24-hour sacrifice). The Geometric Standard Deviations (GSD) of the MMAD were calculated as 2.97 (main study, 14-day sacrifice) or 2.96 (satellite animals, 24-hour sacrifice).
Any other information on results incl. tables
The mean actual exposure concentrations in the breazing zone, the nominal concentration (total amount of the substance fed into the inhalation equipment divided by volume of air), MMADs and GSDs of SE7B were as follows:
Group |
nominal concentration | gravimetric (actual) concentration |
mass median aerodynamic diameter (MMAD) |
geometric standard deviation (GSD) |
Relation of actual to nominal concentration (assumed density = 1 g/mL) |
[μL/L air] | [mg/L air] | [μm] | |||
main study, 14-day sacrifice | 33.33 | 5.07 | 2.488 | 2.97 | 0.15 |
satellite animals, 24-hour sacrifice | 33.33 | 5.06 | 2.46 | 2.96 | 0.15 |
Conclusion
Under the present test conditions, the LC50 value (males and females combined) for rats following inhalation of SE7B for 4 hours was determined as follows (gravimetric concentration):
LC50: > 5.07 mg SE7B/L air
According to the Globally Harmonized Classification System (GHS) the test item should be unclassified (as LD50 > 5 mg/L air). Based on the results of the macroscopic and histopathological investigations, SE7B appears to be slightly irritating for the respiratory epithelium, however, no histological changes could be observed. The changes were almost completely reversible during the 14-day recovery period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the present test conditions, the LC50 value (males and females combined) for rats following inhalation of SE7B for 4 hours was determined as follows (gravimetric concentration):
LC50: > 5.07 mg SE7B/L air
According to the Globally Harmonized Classification System (GHS) the test item should be unclassified (as LD50 > 5 mg/L air). Based on the results of the macroscopic and histopathological investigations, SE7B appears to be slightly irritating for the respiratory epithelium, however, no histological changes could be observed. The changes were almost completely reversible during the 14-day recovery period.
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