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EC number: 948-383-1 | 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- (Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht, Mainz, Germany
Test material
- Reference substance name:
- Fatty acids, C8-10, mixed esters with adipic acid and trimethylolpropane
- EC Number:
- 306-085-3
- EC Name:
- Fatty acids, C8-10, mixed esters with adipic acid and trimethylolpropane
- Cas Number:
- 95912-89-3
- IUPAC Name:
- 95912-89-3
- Details on test material:
- - Name of test material (as cited in study report): Fatty acids, C8-10, mixed esters with adipic acid and trimethylolpropane
- Physical state: yellowish brown liquid
- Analytical purity: 100%
- Lot/batch No.: OE 10428
- Expiration date of the lot/batch: 2013-04-28
- Storage condition of test material: in a closed vessel at room temperature (20 ± 5 °C)
Constituent 1
Test animals / tissue source
- Species:
- other: cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST METHOD
The bovine corneal opacity and permeability (BCOP) test is an in-vitro test method used to classify substances as “ocular corrosives and severe irritants”. The potential of a test substance to cause ocular corrosivity or severe irritancy is measured by its ability to induce opacity and increased permeability in isolated bovine corneas. The opacity and permeability assessments of the corneas are combined to derive an in-vitro irritancy score (IVIS), which is used to classify the irritancy level of the test substance.
IDENTIFICATION OF THE SOURCE OF THE EYES, STORAGE AND TRANSPORT CONDITIONS
- Source: Müller Fleisch GmbH, Birkenfeld, Germany
- Donor animals: 12-60 months
- Transport medium and temperature conditions: Hank’s balanced salt solution (HBSS) supplemented with 0.01% [v/v] penicillin/streptomycin
PREPARATION OF THE EYES (BEFORE EXPOSURE)
- Eyes free of defects (scratches, neovascularisation): yes
- Dissection of the eyes and treatment: corneas were excised with a scalpel and cut from the globe with a 2 to 3 mm ring of sclera around the outside. Each cornea was transferred to a cornea holder, in which pre-warmed complete Minimum Essential Medium (cMEM) without phenol red was filled.
- Description of the cornea holder: the cornea holders consisted of an anterior and a posterior compartment, which interface with the epithelial and endothelial sides of the cornea.
- Test medium and temperature conditions used in the cornea holder: complete Minimum Essential Medium (cMEM) with and without phenol red, supplemented with foetal bovine serum, L-glutamine, sodium bicarbonate and penicillin/streptomycin; prior to use: pre-warmed to 32 ± 1 °C
- Equilibration time: 1 h at 32 ± 1 °C
- Quality check of the equilibrated corneas: free of macroscopic defects, initial opacity< 7 (range: 1.35-2.25 for all corneas)
DETERMINATION OF THE INITIAL OPACITY
- Method: corneal opacity was determined by the amount of light transmission through the cornea using a spectral photometer.
- Specification of the device: Spectral photometer Specord 205, Analytik Jena, Germany
Test system
- Vehicle:
- other: olive oil
- Controls:
- other: number of corneas for the solvent control: 3; number of corneas for the negative control: 3; number of corneas for the positive control: 3
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied in the test: 750 µL
- Concentration (if solution): 10%
SOLVENT CONTROL
- Substance: olive oil
- Amount(s) applied in the test: 750 µL
NEGATIVE CONTROL
- Substance: 0.9% sodium chloride
- Amount(s) applied in the test: 750 µL
POSITIVE SUBSTANCE
- Substance: sodium hydroxide
- Concentration (if solution): 10% in 0.9% sodium chloride
- Amount(s) applied in the test: 750 µL - Duration of treatment / exposure:
- 10 min at 32 ± 1 °C
- Duration of post- treatment incubation (in vitro):
- 2 h
- Number of animals or in vitro replicates:
- number of corneas for the test item: 3
- Details on study design:
- TEST CONDITIONS
- Short description of the method used: closed-chamber method
The respective substance (negative control, positive control, solvent control or the test item solution) was applied by pipetting 750 µL of the appropriate solution through the refill hole in the holder on the cornea. The test item was applied to the epithelium of the cornea in such a manner that as much as possible of the cornea was covered with the test item solution. Each cornea was exposed for a period of 10 min at 32 °C.
POST-EXPOSURE TREATMENT
- Removal of the test substance: first, corneas were rinsed with cMEM containing phenol red followed by a final rinsing with cMEM without phenol red. Afterwards, the anterior chamber was filled with cMEM (without phenol red), and the corneas were stored for an additional 2 h at 32 °C (post-incubation).
- Medium for washing the corneas: cMEM containing phenol red
- Medium for final rinsing: cMEM without phenol red
DETERMINATION OF THE FINAL OPACITY
- Method: corneal opacity was determined by the amount of light transmission through the cornea using a spectral photometer.
- Time of determination: after the post-exposure treatment, the cMEM without phenol red was renewed in both chambers and final opacity was recorded at 570 nm.
- Specification of the device: Spectral photometer Specord 205, Analytik Jena, Germany
DETERMINATION OF THE CORNEAL PERMEABILITY:
- Method: the cMEM without phenol red was removed from the anterior chamber and fluorescein solution was added. The chambers were closed again and incubated for the respective period. After incubation, the content of the posterior chamber was thoroughly mixed, and the concentration of fluorescein solution in this chamber was measured at 490 nm using a spectral photometer.
- Amount and concentration of the dye: 1 mL sodium fluorescein solution (4 mg/mL)
- Incubation time: 90 ± 5 min at ca. 32 ± 1 °C
- Specification of the spectrophotometer: Spectral photometer Specord 205, Analytik Jena, Germany
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 10 min of exposure
- Value:
- 0.217
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- Based on the measurements for opacity and permeability, an In Vitro Irritancy Score (IVIS) ≤ 55 was calculated after treatment with the test substance. The positive and negative controls showed the expected results.
Any other information on results incl. tables
Table 1. Opacity scores after 10 min exposure and 2 h post-treatment incubation period
Treatment group |
Replicate |
Initial opacity |
Final opacity |
Opacity difference |
Mean |
SD |
Test substance (10% in olive oil) |
1 2 3 |
2.2496 1.6110 1.7183 |
2.2341 1.8754 2.2090 |
-0.0155 0.2644 0.4907 |
0.2465 |
0.2536 |
Solvent control (olive oil) |
1 2 3 |
1.4531 1.4904 1.4178 |
1.5136 1.6300 1.6527 |
0.0604 0.1397 0.2350 |
0.1450 |
0.0874 |
Negative control (0.9% NaCl) |
1 2 3 |
1.5646 1.5449 1.5115 |
1.8557 1.8963 1.6734 |
0.2911 0.3514 0.1619 |
0.2681 |
0.0968 |
Positive control (10% NaOH in 0.9% NaCl) |
1 2 3 |
1.6630 1.3465 1.5985 |
174.381 174.864 185.353 |
172.718 173.517 183.755 |
176.663 |
6.155 |
SD = standard deviation
Table 2. Permeability score after 10 min exposure and 2 h post-treatment incubation period
Treatment group |
Replicate |
OD490 |
Correction factor |
Corrected OD490 |
Mean |
SD |
Test substance (10% in olive oil) |
1 2 3 |
0.0048 -0.0012 -0.0009 |
5 5 5 |
0.0240 -0.0060 -0.0045 |
0.0045 |
0.0169 |
Solvent control (olive oil) |
1 2 3 |
-0.0018 -0.0003 0.0002 |
5 5 5 |
-0.0090 -0.0015 0.0010 |
-0.0032 |
0.0052 |
Negative control (0.9% NaCl) |
1 2 3 |
0.0037 0.0039 0.0088 |
5 5 5 |
0.0185 0.0195 0.0440 |
0.0273 |
0.0144 |
Positive control (10% NaOH in 0.9% NaCl) |
1 2 3 |
0.3579 0.3795 0.4826 |
5 5 5 |
1.7895 1.8975 2.4130 |
2.0333 |
0.3332 |
SD = standard deviation
Table 3. In vitro irritancy score (IVIS) after 10 min exposure and 2 h post-treatment incubation period
Treatment group |
IVIS |
||
per cornea |
per group |
||
mean |
RSD [%] |
||
Test substance (10% in olive oil) |
0.569 0.644 0.822 |
0.217 |
19.2 |
Solvent control (olive oil) |
-0.075 0.117 0.250 |
0.098 |
166.5 |
Negative control (0.9% NaCl) |
0.248 0.077 0.326 |
0.678 |
58.6 |
Positive control (10% NaOH in 0.9% NaCl) |
198.883 201.302 219.272 |
206.486 |
5.4 |
RSD = relative standard deviation
Table 4. Validity criteria (according to OECD 437)
Parameter |
Criterion |
Mean value (present study) |
IVIS of negative control (0.9% NaCl) |
0-3 |
0.678 |
IVIS of positive control (10% NaOH) |
103.3-276.1 |
206.486 |
Table 5. IVIS - Historical range of controls
Parameter |
IVIS (Negative control) |
IVIS (solvent control) |
IVIS (Positive control) |
Substance |
0.9% NaCl |
olive oil |
10% NaOH |
Mean |
0.456 |
0.456 |
189.7 |
Standard deviation |
0.773 |
0.352 |
43.2 |
Range (min-max) |
-1.420-2.592 |
0.123-1.072 |
107.7-333.3 |
Range (Validity) |
0-3 |
0-3 |
103.3-276.1 |
Applicant's summary and conclusion
- Interpretation of results:
- other: non-corrosive (Eye Irrit. 2 or not classified) according to Regulation (EC) No 1272/2008
- Conclusions:
- Under the conditions of the test, the test substance was shown to have no corrosive potential in the Bovine corneal opacity and permeability (BCOP) test prediction model. The result does not allow for the non-classification or classification as irritant of the test substance and therefore further evaluation and/or data generation is required.
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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