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EC number: 205-466-0 | CAS number: 141-18-4
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to GLP and state of the art and actual methods and is therefore considered reliable, relevant and adequate.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
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) adipate
- EC Number:
- 205-466-0
- EC Name:
- Bis(2-butoxyethyl) adipate
- Cas Number:
- 141-18-4
- Molecular formula:
- C18H34O6
- IUPAC Name:
- 1,6-bis(2-butoxyethyl) hexanedioate
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Proviplast 0142 (bis(2-butoxyethyl)adipate)
- Chemical Name: Bis(2-butoxyethyl)adipate
- Substance type: liquid
- Physical state: clear liquid with a very faint odour
- Analytical purity:98,83%
- Composition of test material, percentage of components: see Condifential details
- Purity test date: 2011-07-11
- Lot/batch No.:11701913 SA
- Expiration date of the lot/batch: 2012-12-14
- Storage condition of test material: store in tightly closed containers between -20 and +40°C
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, USA and bred at IIBAT animal house facility
- Age at study initiation: not provided
- Weight at study initiation: male: 264-272g; female: 225-254g
- Fasting period before study: not provided
- Housing: standard polypropylene rat cages with stainless steel top grill; the cages were autoclaved; gamma irradiated corn cobs were used as the bedding material, animals were housed individually
- Diet (e.g. ad libitum): standard gamma irradiated rodent pellet feed was provided ad libitum
- Water (e.g. ad libitum): reverse osmosis water was provided ad libitum
- Acclimation period: five days prior to the range finding and main experiment in the test room
ENVIRONMENTAL CONDITIONS
- Temperature (°C): between 20.2 and 22.1°C
- Humidity (%): between 58.0 and 64.3%
- Air changes (per hr): not provided
- Photoperiod (hrs dark / hrs light): 12h light/ 12h dark
IN-LIFE DATES: From: 2011-08-08 To: 2011-08-31
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: body surface area
- % coverage: approximately 10%
- Type of wrap if used: porous gauze
REMOVAL OF TEST SUBSTANCE
- Washing (if done): using cotton soaked in water
- Time after start of exposure: 24 hour
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg body weight
- Concentration (if solution): 100% (as such)
- Constant volume or concentration used: known weight of the test substance
- For solids, paste formed: not applicable - Duration of exposure:
- 24hour
- Doses:
- 2000 mg/kg b.w.
- No. of animals per sex per dose:
- range finding study: 1 male + 1 female; 2000 mg/kg b.w.
limit test (main study): 5 males + 5 females; 2000 mg/kg b.w. - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation daily for 14 days; weighing on day 0 and weekly thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, morbidity/mortality
Results and discussion
- Preliminary study:
- A range finding study was carried out in order to establish the dose levels for the main study. In the range finding study to 1 male and 1 female, the test substance was applied at the dose of 2000 mg/kg b.w.. Following the application, the animals were observed for 4 days. No mortality occurred at the above dose level.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No morbidity/mortality was observed in treated group of rats throughout the observation period
- Clinical signs:
- other: No clinical signs of toxicity were observed in treated group of rats for the entire observation period. No changes were seen in fur, eyes or mucous membrane of the animals. No dermal reactions were observed at the application site.
- Gross pathology:
- Gross pathology examination conducted at the end of 14-day observation dit not reveal any macroscopic lesions.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The dermal LD50 of Proviplast, bis(2-butoxyethyl)adipate was considered as >2000 mg/kg b.w. for Wistar Rats
- Executive summary:
Acute dermal toxicity study (limit test) with bis(2 -butoxyethyl)adipate, Proviplast 0142, was performed in male and female Wistar rats at IIBAT (India) at 2000 mg/kg b.w. of test substance applied to the clipped area of 5 males and 5 females. Following application, the rats were observed for 14 days for morbidity, mortality and clinical sings of toxicity. Animals treated with the test substance did not exhibit any clinical signs of toxicity for the entire observation period. No adverse skin reactions at the site of application were observed following the removal of the test substance. No mortality and morbidity was recorded in rats throughout the observation period. Rats treated with the test substance showed normal body weight during the study. None of the animals showed any macroscopic lesions.
From the experimental results, dermal LD50 of Proviplast 0142, bis(2 -butoxyethyl)adipate, for Wistar rat was determined as > 2000 mg/kg b.w.
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