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EC number: 807-645-4 | CAS number: 701920-77-6
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study complies to OECD Test Guidance 437 and GLP, and is considered to be relevant, adequate and reliable.
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 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- bis[2-(2-butoxyethoxy)ethyl] succinate
- EC Number:
- 807-645-4
- Cas Number:
- 701920-77-6
- Molecular formula:
- C20H38O8
- IUPAC Name:
- bis[2-(2-butoxyethoxy)ethyl] succinate
- Reference substance name:
- bis[2-(2-butoxyethoxy)ethyl]butanedioate
- IUPAC Name:
- bis[2-(2-butoxyethoxy)ethyl]butanedioate
- Reference substance name:
- bis[2-(2-butoxyethoxy)ethyl]succinate
- IUPAC Name:
- bis[2-(2-butoxyethoxy)ethyl]succinate
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): bis[2-(2-butoxyethoxy)ethyl]butanedioate; Di-butoxy-ethoxy-ethyl succinate ; bis[2-(2-butoxyethoxy)ethyl]succinate
- Substance type: Organic mono constituent substance
- Physical state: Colourless liquid
- Analytical purity: 97.1%
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: 91.7%
- Purity test date: 08/07/2014
- Lot/batch No.: 20142205JC
- Expiration date of the lot/batch: Not applicable
- Stability under test conditions: stable
- Storage condition of test material: Room temperature
Constituent 1
Constituent 2
Constituent 3
Test animals / tissue source
- Species:
- other: ex vivo
- Strain:
- other: Bovine cornea
- Details on test animals or tissues and environmental conditions:
- The assay uses isolated corneas obtained as a by-product from animals freshy slaughtered at the abattoir A. Moksel AG, Buchloe, Germany. On the test day, fresh eyes were collected from the slaughterhouse and were transported in HBSS containing Pen/Strep on ice to the laboratories. Immediately after arrival of the eyes, cornea preparation was initiated.
Test system
- Amount / concentration applied:
- The test item was used as provided by the sponsor.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: IVIS
- Basis:
- mean
- Score:
- -1.05
- Max. score:
- 3
- Remarks on result:
- other: Test group
- Irritation parameter:
- other: IVIS
- Basis:
- mean
- Score:
- 2.28
- Max. score:
- 3
- Remarks on result:
- other: Negative control group
- Irritation parameter:
- other: IVIS
- Basis:
- mean
- Score:
- 72.12
- Max. score:
- 55
- Remarks on result:
- other: Positive control group
Any other information on results incl. tables
The
eye irritancy potential of bis[2-(2-butoxyethoxy)ethyl]butanedioate was
investigated in the bovine corneal opacity and permeability assay.
The test item was tested as provided by the sponsor.
The following mean in vitro irritation score was calculated: -1.05.
Therefore
the test item was classified into UN GHS No Category.
The in vitro irritation score obtained with the positive control fell
within the two standard deviations of the current historical mean and
therefore this assay is considered to be valid.
Table 1. Opacity
Cornea |
Test item |
Initial |
Final |
Change of Opacity Value |
Corrected Opacity Value |
1 |
|
4 |
7 |
3 |
|
2 |
4 |
4 |
0 |
|
|
3 |
4 |
5 |
1 |
|
|
MV |
4.00 |
5.33 |
1.33 |
|
|
4 |
|
5 |
58 |
53 |
51.67 |
5 |
5 |
61 |
56 |
54.67 |
|
6 |
5 |
55 |
50 |
48.67 |
|
MV |
5.00 |
58.00 |
53.00 |
51.67 |
|
7 |
|
3 |
4 |
1 |
-0.33 |
8 |
5 |
5 |
0 |
-1.33 |
|
9 |
5 |
5 |
0 |
-1.33 |
|
MV |
4.33 |
4.67 |
0.33 |
-1.00 |
MV = mean value
Table 2. Permeability
Cornea |
Test item |
OD490 |
Corrected |
1 |
|
0.043 |
|
2 |
0.082 |
|
|
3 |
0.065 |
|
|
MV |
0.063 |
|
|
4 |
|
1.778 |
1.715 |
5 |
2.010 |
1.947 |
|
6 |
0.493 |
0.430 |
|
MV |
1.427 |
1.364 |
|
7 |
|
0.083 |
0.020 |
8 |
0.072 |
0.009 |
|
9 |
0.025 |
-0.038 |
|
MV |
0.060 |
-0.003 |
MV = mean value
Table 3. In Vitro Irritation Score
Cornea |
Test item |
Corrected |
Corrected |
IVIS |
1 |
|
3.00 |
0.043 |
2.28 |
2 |
0.00 |
0.082 |
||
3 |
1.00 |
0.065 |
||
MV |
1.33 |
0.063 |
||
4 |
|
51.67 |
1.715 |
72.12 |
5 |
54.67 |
1.947 |
||
6 |
48.67 |
0.430 |
||
MV |
51.67 |
1.364 |
||
7 |
|
-0.33 |
0.020 |
-1.05 |
8 |
-1.33 |
0.009 |
||
9 |
-1.33 |
-0.038 |
||
MV |
-1.00 |
-0.003 |
MV = mean value
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the evaluation criteria the test item bis[2-(2-butoxyethoxy)ethyl]butanedioate is classified into UN GHS No Category.
- Executive summary:
The eye irritancy potential of bis[2-(2-butoxyethoxy)ethyl]butanedioate was investigated in the bovine corneal opacity and permeability assay.
Preparation of the test item was tested as provided by the sponsor (undiluted, 97.1% purity).The assay used three isolated corneas per group obtained as a by-product from animals freshy slaughtered, and both opacity and permeability were measured after 10 minutes incubation at 32+1°C of 750 µL of test/control substance and washing/2h incubation of the epithelium with RPMI medium at 32+1°C. The Mean in vitro irritation score (IVIS) for the tested group was -1.05, which was <3.
The in vitro irritation score obtained with the positive control fell within the expected ranges (<3 and >55, respectively).
According to the evaluation criteria the test item bis[2-(2-butoxyethoxy)ethyl]butanedioate is not classified by the UN GHS or EU CLP criteria.
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