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Diss Factsheets
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EC number: 940-417-3 | CAS number: -
- 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2011-06-28 to 2011-07-13
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Scientifically well performed study; Guideline study; GLP study Rational for the read-across: the registration substance and the read-across supporting substances belong to homologues of butyl-O-(CH2CH2-O)n-butyl
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Bis(2-butoxyethyl) ether
- EC Number:
- 204-001-9
- EC Name:
- Bis(2-butoxyethyl) ether
- Cas Number:
- 112-73-2
- Molecular formula:
- C12H26O3
- IUPAC Name:
- 1,1'-[oxybis(ethane-2,1-diyloxy)]dibutane
- Reference substance name:
- DEGDBE
- IUPAC Name:
- DEGDBE
- Test material form:
- gas under pressure: refrigerated liquefied gas
- Details on test material:
- Name: Diethyleneglycoldibutylether
Chemical Name: Bis(2-butoxyethyl)ether
CAS No.: 112-73-2
Physical State: liquid
pH: 6.5-7.5 (25°C, 100 g/L i-propanol/water 4:1)
Colour: colourless
Storage Conditions: at room temperature
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Full barrier in an air-conditioned room
- Temperature: 22 3 °C
- Relative humidity: 55 10%
- Artificial light, sequence being 12 hours light, 12 hours dark
- Air change: 10 x / hour
- Free access to Altromin 1324 maintenance diet for rats and mice (lot no. 1130)
- Free access to tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
- The animals were kept individually in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding (lot no. 040311)
- Certificates of food, water and bedding are filed at BSL BIOSERVICE
- Adequate acclimatisation period (at least five days)
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- The test item was applied at a single dose, uniformly over an area which was approximately 10% of the total body surface.
The test item was held in contact with the skin by a dressing throughout a 24-hour period. The dressing consisted of a gauze-dressing and non-irritating tape and was fixed with an additional dressing in a suitable manner. - Duration of exposure:
- The test item was held in contact with the skin by a dressing throughout a 24-hour period.
- Doses:
- The test item was applied at a single dose of 2000 mg/kg body weight to each animal.
- No. of animals per sex per dose:
- 5 male and 5 female
- Control animals:
- not required
- Details on study design:
- The test item was held in contact with the skin throughout a 24-hour period. At the end of the exposure period the residual test item was removed using aqua ad injectionem (Berlin Chemie, lot no. 0195A191, expiry date: 04/2013). All animals were observed for 14 days after dosing. The animals were weighed on day 1 (prior to the application) and on days 8 and 15. A careful clinical examination was made several times on the day of dosing (at least once during the first 30 minutes and with special attention given during the first 4 hours post-dose). As soon as symptoms were noticed they were recorded. Thereafter, the animals were observed for clinical signs once daily until the end of the observation period. All abnormalities were recorded.
Cageside observations included changes in the skin and fur, eyes and mucous membranes. Also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern were examined. Attention was directed to observations of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma. All animals were subjected to gross necropsy. All gross pathological changes were recorded.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- approximate LD50
- Effect level:
- > 2 000 mg/kg bw
- Sex:
- female
- Dose descriptor:
- approximate LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- no mortality was observed during the observation period
- Clinical signs:
- other: The test item showed no signs of acute dermal toxicity but minor signs of dermal irritation after a single dose application.
- Gross pathology:
- With the exception of acute injection of blood vessels in the abdominal region, which is due to the euthanasia injection, no specific gross pathological changes were recorded for any animal
- Other findings:
- Eschar was observed in 3 of 5 male and all female animals. Desquamation was observed in 4 of 5 female animals and scratches were observed in 1 of 5 female animals.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute dermal toxicity of the registration substance is derived based on the read-across approach. Diethylenglycoldibuthylether(DEGDBE) was tested for its dermal acute toxicity in rats according to the OECD Guideline 402. At dose level of 2000 mg/kg bw no mortality and no signs of toxicity were observed. The dermal LD50 was determined to be > 2000 mg. Likewise, low acute dermal toxicity is to be assigned for the registration substance. No classification is to be assigned for the registration substance.
- Executive summary:
The acute dermal toxicity of the registration substance is based on the read-across approach, using diethylenglycoldibutylether (DEGDBE) as read-across supporting substance.
DEGDBE was investigated for its dermal toxicity according to the OECD Guideline 402. Five male and female rats each were treated with DEGDBE at doses of 2000 mg/kg bw. No significant effect was observed.
DEGDBE belongs to the homologues of butyl-O-(CH2CH2O)n-butyl with n =2, whereas the main components of the registration substance correspond to the homologues with n = 2,3,4. No toxicity difference is expected based on the basic concept of "chain length category" for the homologues and the observed acute dermal toxicity of DEGDBE is considered to be representative for all components of the registration substance. A low acute dermal toxicity can be reasonably assigned for the registration substance. No classification is to be assigned for the registration substance.
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