Registration Dossier
Registration Dossier
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Diss Factsheets
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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation, other
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- augustus 2011-september 2011
- 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.
- Justification for type of information:
- The DBEA dossier contains old in vivo studies , which are not allowed today. Therefore a justification needs to be added in the end point data summary.
The new legal requirements (21 June 2016) require an in vitro skin irritation study. However the previous data requirements were met with an in vivo study during dossier compilation for the >1000 T/y tonnage band. Therefore there is no need to repeat the study using the alternative test method.
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 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
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 confidential 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: in tightly closed containers between -20 and +40°C
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: from the animal house facility of IIBAT, Padappai-601, 301 Kancheepuram district, Tamil Nadu, India
- Age at study initiation:
- Weight at study initiation: 2167-2260 g
- Housing: individual in standard stainless steel rabbit cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: five days prior to the experiment in the test room
ENVIRONMENTAL CONDITIONS
- Temperature (°C): between 20.6 and 22.1°C
- Humidity (%): between 57 and 63%
- Air changes (per hr): not provided
- Photoperiod (hrs dark / hrs light): The test room was provided with 12h light and 12h dark condition controlled by an automatic timer.
IN-LIFE DATES: From:2011-08-22 To: 2011-09-02
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: left eye instillation of test substance in the left eye; right eye control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
-pH of substance: 7.53 - Duration of treatment / exposure:
- 24 hours following installation
- Observation period (in vivo):
- 72 hours following the installation
- Number of animals or in vitro replicates:
- 3 animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: eyes of test animals were washed
- Time after start of exposure: 24 hours after instillation
SCORING SYSTEM: Draize's method (conjunctiva, cornea and iris)
TOOL USED TO ASSESS SCORE: ophtalmoscope
EXAMINATION: the animals were examined at 1, 24, 48 and 72h after instillation of the test substance
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72h
- Score:
- 0
- Max. score:
- 3
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The maximum mean score for ocular lesions observed in the experiment was 4.00 only at 1 hour. The ocular lesions decreased and the mean score became 0 at 24, 48 and 72 hours after instillation. Hence, under the experimental conditions the test substance, bis(2-butoxyethyl)adipate (Proviplast 0142), was mnimally irritating to the eyes of the New Zealand white rabbits.
- Executive summary:
Acute eye irritation/corrosion potential of bis(2 -butoxyethyl)adipate was tested in female New Zealand white rabbits. In the initial test 0.1 ml of test substances was instilled into the conjunctival sac of the left eye of one rabbit, followed by confirmation in 2 additional rabbits. The right eye of the rabbits served as the control. The eyes of initial and confirmatory test animals were examined and ocular lesions were graded after instillation of the test substance at 1, 24, 48 and 72h. The ocular irritation potential was evaluated bu Draize's method. Test substance treated eye (left) of initial and confirmatory test animals exhibited conjunctival lesions at 1 hour, and cleared at 24h of the observation period.
The maximum mean score for ocular lesions observed in the experiment was 4.00 +/- 0.0 only at 1 hour after instillation. Hence, under the experimental conditions the test substance, bis(2 -butoxyethyl)adipate, was minimally irritating to the eyes of the New Zealand white rabbits, however below the threshold of classification.
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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