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EC number: 263-160-2 | CAS number: 61790-69-0
- 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:
- weight of evidence
- Study period:
- Mar - Apr 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- 09 Oct 2017
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- (from the competent authority) Landesamt für Umwelt Rheinland-Pfalz
Test material
- Reference substance name:
- Fatty acids, tall-oil, reaction products with diethylenetriamine
- EC Number:
- 263-160-2
- EC Name:
- Fatty acids, tall-oil, reaction products with diethylenetriamine
- Cas Number:
- 61790-69-0
- Molecular formula:
- not applicable (UVCB substance)
- IUPAC Name:
- Fatty acids, tall-oil, reaction products with diethylenetriamine
- Test material form:
- other: solid, waxy, white to yellowish
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No.of test material: 0017319511
- Expiration date of the batch: 18 Dec 2018
- Purity: > 99 %
- pH value: ca. 6
- Physical state / color: Solid, waxy / white to yellowish
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: To improve application, the solid waxy test substance was heated at about 50 °C for about 15 minutes. Before application, the test substance was cooled down to room temperature.
Test animals / tissue source
- Species:
- cattle
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: Schlachthof Alzey, Emil Färber GmbH & Co. KG, Robert-Bosch-Straße 23, 55232 Alzey, Germany
- Characteristics of donor animals (e.g. age, sex, weight): min. 12 months and max. 60 months old
- indication of any existing defects or lesions in ocular tissue samples: no
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 µL - Duration of treatment / exposure:
- 4 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
Bovine eyes are obtained as a by-product of freshly slaugthered cattle (age of the animals: minimum 12 months, maximum 60 months).
QUALITY CHECK OF THE ISOLATED CORNEAS
Corneas free of defects (opacity, scratches, pigmentation etc.) were dissected with a 2 to 3 mm rim of sclera. Isolated corneas were mounted in cornea holders that consists of anterior and posterior chambers. Both chambers were filled to excess with pre-warmed Eagle's MEM (without phenol red) and then equilibrated in a vertical position at about 32 °C for at least 1 hour. After the equilibration period, the medium in both chambers was replaced by fresh pre-warmed medium and initial corneal opacity readings were taken for each cornea with an opacitometer. Any corneas that showed macroscopic tissue damage or an opacity value < 556 opacity units were discarded. The remaining corneas were then distributed into negative control, positive control and treatment groups. Each corneal holder was uniquely identified with a number on the chambers.
NUMBER OF REPLICATES
3
NEGATIVE CONTROL USED
deionized water
POSITIVE CONTROL USED
Imidazole (CAS-No. 288-32-4) 20 % (w/v) solution in deionized water for non-surfactant solid test substances
APPLICATION DOSE AND EXPOSURE TIME
750 µL for 4 hours
TREATMENT METHOD: closed chamber
POST-INCUBATION PERIOD: no
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: The NC and the PC were removed from the anterior chamber by using a syringe and the epithelium was washed at least 3 times with Eagle's MEM (containing phenol red) and once with Eagle's MEM (without phenol red). Because the test substance could not be removed by using a syringe the epithelium was rinsed with the open chamber method.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: Before measurement, each cornea was visually observed and observations were recorded. Final corneal opacity readings were taken for each cornea with an opacitometer.
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of UV/VIS spectrophotometry (OD490)
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: decision criteria according to the OECD Guideline 437 (adopted 09 Oct 2017)
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- mean
- Value:
- 9.7
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 1: Opacity score of the test substance, the NC and the PC
Test substance identification |
Cornea-No. |
Initial opacity |
Final opacity |
Opacity change |
Corrected opacity change* |
Mean |
SD |
Test substance |
7 8 9 |
3.2 4.0 4.9 |
8.9 8.2 8.5 |
5.7 4.2 3.5 |
0.0 0.0 0.0 |
0.0 |
0.0 |
NC |
1 2 3 |
4.5 5.5 7.0 |
15.2 12.9 9.1 |
10.7 7.5 2.1 |
NA NA NA |
6.7 |
4.3 |
PC |
4 5 6 |
4.1 4.9 2.9 |
104.8 96.5 113.3 |
100.7 91.5 110.4 |
93.9 84.8 103.7 |
94.1 |
9.5 |
* negative values are set to zero for further calculation
Table 2: Permeability score of the test substance, the NC and the PC
Test substance identification |
Cornea-No. |
Mean OD490 |
Dilution factor |
Mean corrected OD490 |
Mean |
SD |
Test substance |
7 8 9 |
0.929 0.447 0.581 |
1 1 1 |
0.925 0.443 0.577 |
0.648 |
0.249 |
NC |
1 2 3 |
0.005 0.004 0.003 |
1 1 1 |
NA NA NA |
0.004 |
0.001 |
PC |
4 5 6 |
0.266 0.491 0.345 |
5 5 5 |
1.328 2.449 1.721 |
1.833 |
0.569 |
Table 3: In Vitro Irritancy Score (IVIS) of the test substance, the NC and the PC
Test substance identification |
Cornea-No. |
Opacity per cornea* |
Permeability per cornea |
IVIS |
||
Per cornea |
Per group |
|||||
Mean |
SD |
|||||
Test substance |
7 8 9 |
0.0 0.0 0.0 |
0.925 0.443 0.577 |
13.9 6.6 8.7 |
9.7 |
3.7 |
NC |
1 2 3 |
10.7 7.5 2.1 |
0.005 0.004 0.003 |
10.7 7.5 2.1 |
6.8 |
4.3 |
PC |
4 5 6 |
93.9 84.8 10.37 |
1.328 2.449 1.721 |
113.9 121.5 129.5 |
121.6 |
7.8 |
* negative values are set to zero for further calculation
Applicant's summary and conclusion
- Interpretation of results:
- other: no severe eye irritant/no eye damage
- Conclusions:
- No prediction can be made for eye irritation according to GHS criteria based on the results of this in vitro study alone.
- Executive summary:
The potential of the test substance to cause ocular irritation or serious damage to the eyes was assessed by a single topical application of 750 µL undiluted test substance to the epithelial surface of isolated bovine corneas.
The solid, waxy test substance could not be homogeneously prepared as a 20 % preparation in deionized water. Therefore, a piece of Parafilm (matched to the size of the application area) was covered with 750 µL of the undiluted (at ca. 50 °C heated) test substance and was applied directly to the epithelial surface of the cornea. Before application, the test substance was cooled down to room temperature. Three corneas were treated with the test substance for an exposure period of 4 hours. In addition to the test substance, a negative control (NC; deionized water) and a positive control (PC; 20 % imidazole in deionized water) were applied to three corneas each. Corneal opacity was quantitatively measured as the amount of light transmitted through the cornea. Permeability was quantitatively measured as the amount of sodium fluorescein dye that passes across the full thickness of the cornea. Both measurements were used to calculate an In Vitro Irritancy Score of the test substance. The following results were obtained in the BCOP Test:
Table 1: Mean values for opacity, permeability and IVIS of the test substance, the NC and the PC
Test substance identification
Mean Opacity Value
Mean Permeability Value
Mean In Vitro Irritancy Score
Test substance
0.0
0.648
9.7
NC
6.7
0.004
6.8
PC
94.1
1.833
121.6
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