Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 272-905-0 | CAS number: 68919-79-9
- 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:
- February 23, 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to OECD Guideline 437 and EU Method B.47, in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
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:
- yes
- Remarks:
- "The measurement of the opacity was performed with a photometer (570 nm) instead of an opacitometer." This deviation was considered as uncritical, because the opacity can be calculated from the absorbance.
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Deviations:
- yes
- Remarks:
- "The measurement of the opacity was performed with a photometer (570 nm) instead of an opacitometer." This deviation was considered as uncritical, because the opacity can be calculated from the absorbance.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Fatty acids, tall-oil, reaction products with triethylenetetramine
- EC Number:
- 272-905-0
- EC Name:
- Fatty acids, tall-oil, reaction products with triethylenetetramine
- Cas Number:
- 68919-79-9
- Molecular formula:
- Not applicable for this UVCB.
- IUPAC Name:
- Fatty acids, tall-oil, reaction products with triethylenetetramine
- Test material form:
- semi-solid (amorphous): gel
- Remarks:
- migrated information: paste
Constituent 1
Test animals / tissue source
- Species:
- other: Bos primigenius Taurus (fresh bovine corneas)
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: in vitro test
- Amount / concentration applied:
- 791.6, 1,063.8 and 1,199.9 mg (applied directly on the cornea using a weight board)
- Duration of treatment / exposure:
- 4 h
Results and discussion
In vivo
Results
- Irritation parameter:
- other: in vitro irritancy score (IVIS)
- Basis:
- mean
- Time point:
- other: 4 h
- Score:
- 5.17
- Irritant / corrosive response data:
- In the negative control, no signs of eye irritation were observed. The positive control induced serious eye damage, which would be classified as GHS category 1.
The test substance produced effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is 5.170.
The experiment is considered as sufficient for the classification of the test substance, because all three replicates of the test substance lead to the same assessment for the test substance.
Any other information on results incl. tables
The absorbance (570 nm) and opacity values which were measured before and after exposition are given in the following table:
Table 1: Absorbance and Opacity Values Negative Control
Parameter |
Negative Control |
||
Absorbance before exposition |
0.1524 |
0.1586 |
0.1575 |
Absorbance after exposition |
0.3357 |
0.2667 |
0.2902 |
Opacity before exposition |
1.4204 |
1.4408 |
1.4371 |
Opacity after exposition |
2.1662 |
1.848 |
1.9507 |
Opacity Difference |
0.7458 |
0.4072 |
0.5136 |
Mean opacity difference of the negative control was 0.5555
Table 2: Absorbance and Opacity Values Test Substance and Positive Control
Parameter |
Test substance |
Positive Control |
||||
Absorbance before exposition |
0.2603 |
0.1417 |
0.1195 |
0.1184 |
0.1849 |
0.1239 |
Absorbance after exposition |
0.2702 |
0.2478 |
0.2602 |
1.6291 |
1.8528 |
1.7304 |
Opacity before exposition |
1.821 |
1.3858 |
1.3167 |
1.3134 |
1.5307 |
1.3301 |
Opacity after exposition |
1.8629 |
1.7693 |
1.8205 |
42.5696 |
71.2525 |
53.7527 |
Opacity Difference |
0.042 |
0.3835 |
0.5038 |
41.2562 |
69.7217 |
52.4225 |
For the permeability measurement, three replicates for each treatment group were measured. The optical density values at 490 nm are given in the following table:
Table 3: Optical density at 490 nm
Repl. |
Negative Control |
Test Substance |
Positive Control |
||||||
Meas. |
0.0041 |
0.0029 |
0.0028 |
0.0921 |
0.0734 |
0.0609 |
0.3978 |
0.2436 |
0.3568 |
Corr. |
0.0205 |
0.0145 |
0.0140 |
0.4605 |
0.3670 |
0.3045 |
1.9890 |
1.2180 |
1.7840 |
Mean |
0.0163 |
---- |
Table 2: IVIS
Test group |
IVIS |
Mean IVIS |
Relative standard deviation IVIS |
Negative Control 0.9% NaCl |
1.053 |
0.801 |
28.0% |
0.625 |
|||
0.724 |
|||
Test substance |
6.149 |
5.170 |
18.2% |
5.088 |
|||
4.271 |
|||
Positive Control 20% imidazole solution |
70.3 |
78.6 |
10.8% |
87.2 |
|||
78.4 |
Applicant's summary and conclusion
- Conclusions:
- The test substance produced effects on the cornea of the bovine eye with a calculated IVIS (in vitro irritancy score) of 5.170, according to OECD Guideline 437. The experiment is considered as sufficient for the classification of the test substance because all three replicates of the test substance lead to the same assessment (Andres, 2015).
- Executive summary:
A study was conducted to assess the corneal damage potential of the test substance in bovine cornea by measuring opacity and permeability according to OECD Guideline 437 and EU Method B.47, in compliance with GLP. The pure test substance was brought onto the cornea of a bovine eye for 4 h at 32 ± 1°C, which had been previously incubated in cMEM, without phenol red, at 32 ± 1°C for 1 h. After removal of the test substance, opacity and permeability values were measured. Under the study conditions, the test substance produced effects on the cornea of the bovine eye with a calculated IVIS (in vitro irritancy score) of 5.170. The negative control (physiological sodium chloride solution) and the positive control (20% imidazole solution) met the validity criteria. The experiment was considered as sufficient for the classification of the test substance as eye irritant because all three replicates of the test substance lead to the same assessment (Andres I, 2015b).
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.