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EC number: 205-575-3 | CAS number: 142-96-1
- 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
Toxicity to reproduction: other studies
Administrative data
- Endpoint:
- toxicity to reproduction: other studies
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted as per OECD TG 412, EC Method B.8 and in accordance with the Principles of Good Laboratory Practice (GLP).
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 412 (Repeated Dose Inhalation Toxicity: 28/14-Day
- Deviations:
- yes
- Remarks:
- (Deviations observed during the conduct of the range and the main study were not considered to have influenced the integrity and validity of the study results)
- Qualifier:
- according to guideline
- Guideline:
- other: EU Method B.8 (Repeated Dose (28 Days Toxicity (Inhalation)
- Deviations:
- yes
- Remarks:
- same as above
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes
- Type of method:
- in vivo
Test material
- Reference substance name:
- Dibutyl ether
- EC Number:
- 205-575-3
- EC Name:
- Dibutyl ether
- Cas Number:
- 142-96-1
- Molecular formula:
- C8H18O
- IUPAC Name:
- 1-butoxybutane
- Reference substance name:
- n-dibutyl ether
- IUPAC Name:
- n-dibutyl ether
- Details on test material:
- - Name of test material (as cited in study report): n-dibutylether
- Physical state: colourless volatile liquid
- Analytical purity: range finding - > 99.3%, main study - > 99.76%
- Lot/batch No.: range finding - 0000093881, main study - 0000100437
- Expiration date of the lot/batch: range finding - 19 december 2004, main study - 31 July 2005
- Storage condition of test material: ambient temperature, dark, protected from air
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfield, Germany
- Age at study initiation: 7-9 weeks
- Weight at study initiation: mean male weight - 226 gram, mean female weight - 175 gram
- Housing: standard housing conditions
- Diet (e.g. ad libitum): ad libitum from the arrival of rats until the end of the study, except during exposure and during overnight fasting prior to necropsy
- Water (e.g. ad libitum): ad libitum from the arrival of rats until the end of the study, except during exposure and during overnight fasting prior to necropsy
- Acclimation period: 9 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30-70%
- Air changes (per hr): 10 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure (if applicable):
- nose only
- Vehicle:
- air
- Details on exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Animals were exposed to the test atmosphere in noe-only exposure units, each unit consisted of a cylindrical column, surrounded by a transparent cylinder. The column consisted of a top assembly with the inlet of the test atmosphere, one or two rodent tube sections and at the bottom the base assembly with the exhaust port.
- Method of holding animals in test chamber: Each rodent tube section had 20 ports for animal exposure. The animals were secured in plastic animal holders (Battelle), positioned radially through the outer cylinder around the central column (males and females alternated). Several empty ports were used for test atmosphere sampling and measurement of temperature and relative humidity. The extra remaining ports were closed. Only the nose of the rats protruded into the interior of the column. Animals were rotated on a weekly basis in such a way that at the end of the exposure period, the animals were at about the initial location again. The units were illuminated externally by normal laboratory TL-lighting.
- Source and rate of air: The test atmosphere for each exposure level was generated by passing humidified air for each exposure unit through glass evaporators. The test material was pumped as a liquid in the evaporators using syringe pumps. The air streams measured by rotameters were directed to the exposure units. At the bottom of the units the test atmospheres were exhausted. The rotameters and the syringe pumps were read out and recorded at regular intervals (approximately bi-hourly, i.e. 3 times a day). The rotameters were calibrated at 3 settings in triplicate.
- Temperature, humidity, pressure in air chamber: 22 ± 3 °C, 30-70% relative humidity
TEST ATMOSPHERE
- Brief description of analytical method used: The concentration of n-dibutylether in the test atmosphere was measured by infrared analysis at 3.4 µm. The response of the analyser was recorded by an analogue recorder. Also, the concentration of n-dibutylether in the test atmospheres was measured by total carbon analysis for the low and mid concentration test atmospheres, the response was recorded by an analogue recorder. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The mean concentrations were 151 ± 3, 497 ± 3 and 1497 ± 3 mg n-dibutylether/m3
- Duration of treatment / exposure:
- 28 days followed by a 2-week recovery period
- Frequency of treatment:
- daily 6 hours/day, 5 days/week for 4 weeks (a total of 20 exposures) daily during the exposure period.
- Duration of test:
- 28 days followed by a 2-week recovery period
Doses / concentrations
- Remarks:
- Doses / Concentrations:
150, 500 and 1500 mg/m³ (actual concentration)
Basis:
other: mean actual concentrations were 151 ± 3, 497 ± 3 and 1497 ± 3 mg n-dibutylether/m3, mean nominal concentrations were 179, 538 and 1553 mg/m3
- No. of animals per sex per dose:
- 5 males + 5 females/test group and 5 males + 5 females - control and 1500 mg/m3 reversal group
- Control animals:
- yes, sham-exposed
- Details on study design:
- - Dose selection rationale: based on the results of the range finding study with exposure concentrations of 0, 1000, 3000 and 10000 mg/m3 (reduced to 6500 mg/m3 since ataxia was observed in the exposed males after first exposure to 10000 mg/m3 of n-dibutylether)
- Rationale for animal assignment: computer randomization taking body weights into account
- Post-exposure recovery period in satellite groups: 2 weeks - control and high dose reversal groups - Statistics:
- Standard statistical methods were employed
Results and discussion
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 1 500 mg/m³ air
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: based on overall effects
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/m³ air
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: based on body weight reduction noted in the first exposure week at the highest dose of 1500 mg/m3
- Dose descriptor:
- LOAEL
- Effect level:
- 1 500 mg/m³ air
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: based on overall effects
Observed effects
Any other information on results incl. tables
There were no concentration-related effects on relative and absolute organ weights of testes, epididymides, ovaries and uterus. Also there were no substance-related macroscopical or histopathological changes in testes, epididymides, prostata, seminal vesicles, coagulating glands, ovaries, uterus, vagina and mammary gland.
Applicant's summary and conclusion
- Conclusions:
- There were no concentration-related effects on relative and absolute organ weights of testes, epididymides, ovaries and uterus. Also there were no substance-related macroscopical or histopathological changes in testes, epididymides, prostata, seminal vesicles, coagulating glands, ovaries, uterus, vagina and mammary gland.
Overall, the results of the study, it can be concluded that exposure to concentrations of 150, 500 and 1500 mg of n-dibutylether/m3 concentrations did not result in treatment related effects in male rats and only in limited effects in females exposed to 1500 mg/m3. Exposure to 1500 mg/m3 resulted in a temporary body weight loss in these females during the first exposure week. After this week, including the 14-day recovery period, growth was comparable to the control group. This weight loss can be considered as a temporaray effect and the highest expsoue of 1500 mg/m3 can therefore be considered as the Low observed adverse effect level (LOAEL) for both the sexes. The No observed adverse effect level (NOAEL) for male rats can be considered as 1500 mg/m3 and for female rats the mid dose of 500 mg/m3. - Executive summary:
The 28 -day inhalation toxicity study was conducted according to OECD TG 412, EC Method B.8 and in accordance with the Principles of Good Laboratory Practice (GLP). Groups of 5 male and 5 female rats were exposed to n-dibutylether at concentrations of 150, 500 and 1500 mg/m3 (based on the results of a 7 -day inhalation toxicity study at concentrations of 1000, 3000 and 10000 mg/m3 (later reduced to 6500 mg/m3 as all animals of 10000 mg/m3 exhibited signs of ataxia). Also, a concurrent control was used in the study along with the control and the 1500 mg/m3 reversal group.
There were no exposure related clinical signs, haematology, clinical chemistry and urinalysis and organ weights. In addition treatment realted changes were not evident in gross pathology of all the animals of the main study and the reversal group and no evidence of any treatment related histopathjological changes in any organs. The only exposure related change noted was a decrease in the body weight gain of the high dose group during the first week of exposure, thereafter the weekly body weight gain was comparable to the other groups including control.
There were no concentration-related effects on relative and absolute organ weights of testes, epididymides, ovaries and uterus. Also there were no substance-related macroscopical or histopathological changes in testes, epididymides, prostata, seminal vesicles, coagulating glands, ovaries, uterus, vagina and mammary gland.
Overall, the results of the study, it can be concluded that exposure to concentrations of 150, 500 and 1500 mg of n-dibutylether/m3 concentrations did not result in treatment related effects in male rats and only in limited effects in females exposed to 1500 mg/m3. Exposure to 1500 mg/m3 resulted in a temporary body weight loss in these females during the first exposure week. After this week, including the 14-day recovery period, growth was comparable to the control group. This weight loss can be considered as a temporaray effect and the highest expsoue of 1500 mg/m3 can therefore be considered as the Low observed adverse effect level (LOAEL) for both the sexes. The No observed adverse effect level (NOAEL) for male rats can be considered as 1500 mg/m3 and for female rats the mid dose of 500 mg/m3.
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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