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EC number: 288-927-9 | CAS number: 85940-40-5
- 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
- Remarks:
- In vitro eye irritation EpiOcular assay
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2012/13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- MatTek Corporation, Ashland, MA 01721, USA: EpiOcularTM human cell construct: Procedure details, Version 3.1 a of February 10, 2010.
Harbell J.W. et al. (2009): COLIPA Program on Optimization of Existing ln Vitra Eye Irritation Assays for Entry into Formal Validation: Technology Transfer and Intra/Inter Labaratory Evaluation of EpiOcular Assay for Chemicals. Poster # 378, Society of Toxicology, March 2009. - GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Fatty acids, tall-oil, reaction products with pentaethylenehexamine
- EC Number:
- 288-927-9
- EC Name:
- Fatty acids, tall-oil, reaction products with pentaethylenehexamine
- Cas Number:
- 85940-40-5
- Molecular formula:
- Not applicable (UVCB substance)
- IUPAC Name:
- Fatty acids, tall-oil, reaction products with pentaethylenehexamine
- Test material form:
- liquid: viscous
Constituent 1
Test animals / tissue source
- Species:
- other: EpiOcular™ OCL-200 kit
- Strain:
- other: 24 OCL-200 tissues (reconstructed cornea): surface 0.6 cm2 cultured in Millicells® diameter 1 cm, MatTek Corp., Ashland MA, USA
- Details on test animals or tissues and environmental conditions:
- - Justification of the test method and considerations regarding applicability
: The EpiOcularTM model (OCL-200) is a three-dimensional non-keratinized tissue construct composed of normal human derived epidermal keratinozytes used to model the human corneal epithelium. The EpiOcularTM tissues (surface 0.6 cm²) are cultured on specially prepared cell culture inserts (MILLICELLs, 10 mm ∅) and are commercially available as kits (EpiOcular™ 200), containing 24 tissues on shipping agarose.
- Description of the cell system used, incl. certificate of authenticity and the mycoplasma status of the cell live
- Tissue for MTT reduction control: OCL-200 tissue that is killed by freezing at -20°C
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- other: MTT reduction control (KC): de-ionized water or test substance
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µL
- Concentration (if solution): undiluted test substance - Duration of treatment / exposure:
- 30 min at 37 °C
- Duration of post- treatment incubation (in vitro):
- 2 h at 37 °C
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- - Details of the test procedure used
: see above
- Tissue construct used, including batch number : see above, batch number not specified
- Doses of test chemical and control substances used : 50 µL
- Duration and temperature of exposure, post-exposure immersion and post-exposure incubation periods (where applicable) : Exposure - 30 min at 37 °C, post incubation - 2 h at 37 °C
- Description of any modifications to the test procedure : not applicable
- Number of tissue replicates used per test chemical and controls (positive control, negative control, NSMTT, NSCliving and NSCkilled, if applicable) : see above
- Wavelength and band pass (if applicable) used for quantifying MTT formazan, and linearity range of measuring device (e.g. spectrophotometer) : wavelength 570 nm, no further information available
- Description of the method used to quantify MTT formazan : The optical density at a wavelength of 570 nm (OD570) of the extracts was determined spectrophotometrically. Blank values were established of 4 microtiter wells filled with isopropanol for each microtiter plate.
- Description of evaluation criteria used including the justification for the selection of the cut-off point for the prediction model : see below
- Reference to historical positive and negative control results demonstrating suitable run acceptance criteria : see table 2
- Demonstration of proficiency in performing the test method before routine use by testing of the proficiency chemicals : Based on the historical data, a profound experience with the assay is assumed
- Positive and negative control means and acceptance ranges based on historical data : see table 2
- Acceptable variability between tissue replicates for positive and negative controls : Tissue viability is acceptable if the mean OD570 of the NC is ≥ 1.0. The mean OD570 of the NC
should not exceed 2.5. Methyl acetate used as PC usually leads to a tissue viability of approx. 25%. A viability of < 50% is acceptable.
- Acceptable variability between tissue replicates for the test chemical: A variability between the tissues is considered to be acceptable if the difference of the viability is ≤ 20%.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Remarks:
- Mean tissue viability
- Value:
- 5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: not reported
DEMONSTRATION OF TECHNICAL PROFICIENCY: Based on the historical data, a profound experience with the assay is assumed
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
- Range of historical values: see table 2
Any other information on results incl. tables
Table 1: Findings
Test substance |
|
tissue 1 |
tissue 2 |
mean KC |
mean* |
inter-tissue variability [%] |
NC |
mean OD570 |
2.101 |
2.106 |
0.047 |
2.104 |
|
viability [% of NC] |
99.9 |
100.1 |
- |
100 |
0.3 |
|
Test substance |
mean OD570 |
0.941 |
0.759 |
0.790 |
0.107 |
|
viability [% of NC] |
44.7 |
36.1 |
35.3 |
5 |
8.6 |
|
PC |
mean OD570 |
0.593 |
0.494 |
- |
0.544 |
|
viability [% of NC] |
28.2 |
23.5 |
- |
26 |
4.7 |
*For the test substance the mean is given after KC-correction.
The MTT reduction control (KC) showed high values of the test substance (mean formazan production of the KC: 35%). Thus the acceptance criterion of ≤ 30% of the NC was not met. However, as all other acceptance criteria were met in the test and because the test substance would have been evaluated as irritant even without KC-correction, the test was considered valid despite this deviation.
Table 2: Historical control data
Historical Range of NC | |||||
OD570 | |||||
Protocol | Historical Period | Mean OD | SD | Mean + 2 SD | Mean - 2 SD |
Protocol for liquids | Apr 2010 - Aug 2012 | 1.532 | 0.213 | 1.96 | 1.11 |
Protocol for solids | Apr 2010 - Aug 2012 | 1.35 | 0.168 | 1.69 | 1.01 |
Historical Range of PC | |||||
OD570 | |||||
Protocol | Historical Period | Mean OD | SD | Mean + 2 SD | Mean - 2 SD |
Protocol for liquids | Apr 2010 - Aug 2012 | 0.390 | 0.151 | 0.69 | 0.09 |
Protocol for solids | Apr 2010 - Aug 2012 | 0.284 | 0.113 | 0.51 | 0.06 |
Viability (%) | |||||
Protocol |
Historical Period |
Mean OD |
SD |
Mean + 2 SD |
Mean - 2 SD |
Protocol for liquids |
Apr 2010 - Aug 2012 |
24.94 |
6.99 |
38.91 |
10.96 |
Protocol for solids |
Apr 2010 - Aug 2012 |
21.01 |
7.09 |
35.20 |
6.83 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Based on the observed results and applying the evaluation criteria it was concluded, that the test item shows an eye irritation potential in the EpiOcular™ eye irritation test under the test conditions chosen.
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