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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 268-069-1 | CAS number: 68002-54-0
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 16 August 2010 to 16 September 2010
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Principles of method if other than guideline:
- The study was conducted in accordance with the draft guideline OECD Guideline for the Testing of Chemicals, Draft Proposal for a New Guideline, In Vitro Skin Irritation: Reconstructed Human Epidermis (RhE) Test Method, Version 4, 11 December 2009.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Fatty acids, tall-oil, compds. with ethanolamine
- EC Number:
- 268-640-5
- EC Name:
- Fatty acids, tall-oil, compds. with ethanolamine
- IUPAC Name:
- Fatty acids, tall-oil, compds. with ethanolamine
- Test material form:
- other: liquid (unspecified)
- Details on test material:
- - Appearance: untransparent, yellow liquid
- Storage Conditions: ambient temperature
Constituent 1
Test animals
- Species:
- other: in vitro Reconstructed Human Epidermis (RHE) Model
- Details on test animals or test system and environmental conditions:
- The EpiDerm EPI-200 skin model consists of normal human epidermal keratinocytes (NHEK) from one single donor, derived from neonatal-foreskin tissue. The keratinocytes are plated on chemically modified, collagen-coated, 8 mm ID cell culture inserts (surface area 0.5 cm²). The skin models are commercially available.
Upon arrival at the testing laboratory, the EPI-200 skin models were pre-incubated in 0.9 mL assay medium provided with the kit for 60 minutes (at ca. 37 °C and ca. 5 % CO₂). At the end of the first pre-incubation period, the tissues were additionally pre-incubated overnight for 21 to 24 hours (at ca. 37 °C and ca. 5 % CO₂).
EPI-200 skin model supplier: MatTek Corporation, USA
Test system
- Type of coverage:
- other: not applicable
- Preparation of test site:
- other: not applicable
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: in vitro controls were used
- Amount / concentration applied:
- 30 µL
- Duration of treatment / exposure:
- A treatment period of 60 minutes was followed by a post-exposure incubation period of 42 hours.
- Observation period:
- Not applicable
- Number of animals:
- Not applicable
- Details on study design:
- REFERENCE MATERIALS
- Positive control: 5 % Sodium Lauryl Sulphate (SLS) in demineralised water (= 5 % Sodium Dodecyl Sulphate (SDS))
- Negative control: Phosphate Buffered Saline (PBS)
PRELIMINARY TEST
The tissue staining potential of the test material was investigated prior to the main study by incubating 30 µL in 300 µL of demineralised water for 1 hour (at ca. 37 °C). At the end of the exposure time, the presence and intensity of the staining (if any) was evaluated. The test material did not change the colour of the solution; therefore, it was concluded that the test material did not have the potential to stain the tissue.
Some chemicals are known to non-specifically reduce MTT, resulting in a blue precipitate. Therefore, prior to the start of the main study, 30 µL of the test material was incubated in 1 mL of 1 mg/mL MTT solution for 3 hours (at ca. 37 °C) and the formation of a blue formazan product was assessed. The test material did not show MTT reducing capacity, i.e. the solution did not turn blue/purple.
Furthermore, the test material showed no interaction with a nylon mesh. Therefore, nylon mesh was used to facilitate equal distribution of the test material.
EXPOSURE TO THE TEST MATERIAL
After overnight pre-incubation, the skin membranes were exposed to 30 µL of the test material, positive or negative controls in triplicate for 60 ± 2 minutes. The test material was manually shaken just before application to facilitate homogenisation. Immediately after application, a nylon mesh (provided with the EPI-200 kit) was placed onto the tissue surface to facilitate an equal distribution of the test material.
Exposure was performed at ambient temperature in a flow cabin in four series, including one series of frozen controls. After dosing the last tissue of each series, the plates containing the skin membranes were transferred to a humidified incubator (ca. 37 °C and ca. 5 % CO₂). After 35 ± 1 minutes, the plates were removed from the incubator and placed in the flow cabin until the exposure period of 60 minutes was completed for the first dosed tissue. When the exposure period was completed, the inserts were removed from the well and the skin surface was carefully washed using an excess of phosphate buffered saline (PBS).
Subsequently, the insert was blotted dry and the tissue surface was carefully dried using a sterile cotton swab. The insert was then transferred to clean 6-well plate containing fresh medium (0.9 mL/well). Medium was refreshed after 18 ±2 hours. Following an additional 22.5 hours incubation period at ca. 37 °C and ca. 5 % CO₂ in a humidified incubator, viability was determined using the MTT assay.
MTT ASSAY
An MTT solution of 1 mg/mL was prepared by diluting MTT concentrate 5 times in MTT diluent (both provided with the kit). The bottom of the inserts was blotted dry and the inserts placed in a 24-well plate containing 300 µL of MTT medium/well. The plates were placed in an incubator at ca. 37 °C and ca. 5 % CO₂. After 180 ± 1 minutes, the tissues were rinsed three times with PBS. The formazan product was extracted from the tissue using 2 mL MTT extractant (provided with the kit). Extraction was performed in the dark for 2 days at 2 to 10 °C.
After completion of the extraction period, the skin membrane was pierced with a needle to allow the extract to run into the well from which the membrane was taken. The optical density was measured in triplicate in 200 µL sub-fractions using a spectrophotometer set at 570 nm. Extractant solvent alone was used as blank. The mean optical density was calculated and expressed as the percentage viability compared to the negative control.
INTERPRETATION OF THE RESULTS
The test is considered valid if the optical density of the negative control is ≥1.0 and ≤2.5 and the optical density of the extractant solvent alone is <0.1. Tissues treated with the positive control should reflect their ability to respond to an irritant chemical.
The irritation potential of the test material was determined from the relative mean tissue viability compared to the negative control tissues, using the following prediction model:
Mean tissue viability in vitro In vivo prediction
(% of negative control)
Mean tissue viability ≤50 % Irritant
Mean tissue viability >50 % Non-irritant
Results and discussion
In vivo
- Irritant / corrosive response data:
- The results are summarised in Table 1.
The mean optical density of the test material was 94 % of the negative control.
The optical densities of the negative and positive control were within the acceptable ranges and correctly indicated non irritancy and irritancy, respectively. This demonstrated validity of the model.
Any other information on results incl. tables
Table 1 Summary of Control and Test Material Results
Material |
|
MTT Conversion (OD₅₇₀) |
||||
Measurement 1 |
Measurement 2 |
Measurement 3 |
Replicate Mean |
|||
Negative Control |
Replicate 1 |
1.924 |
1.921 |
1.983 |
1.943 |
|
Replicate 2 |
1.980 |
1.978 |
1.995 |
1.984 |
||
Replicate 3 |
1.933 |
1.975 |
1.970 |
1.959 |
||
Mean |
1.962 |
|
||||
SD |
0.021 |
|||||
% CV |
1.1 |
|||||
% of control |
100 |
|||||
Test Material |
Replicate 1 |
2.060 |
2.090 |
2.059 |
2.070 |
|
Replicate 2 |
1.611 |
1.643 |
1.630 |
1.628 |
||
Replicate 3 |
1.828 |
1.861 |
1.837 |
1.842 |
||
Mean |
1.847 |
|
||||
SD |
0.221 |
|||||
% CV |
12.0 |
|||||
% of control |
94 |
|||||
Positive Control |
Replicate 1 |
0.127 |
0.136 |
0.138 |
0.134 |
|
Replicate 2 |
0.137 |
0.137 |
0.135 |
0.136 |
||
Replicate 3 |
0.133 |
0.132 |
0.133 |
0.133 |
||
Mean |
0.134 |
|
||||
SD |
0.002 |
|||||
% CV |
1.4 |
|||||
% of control |
7 |
Data shown in the table were corrected for background absorbance values (extractant solvent alone), which were on average 0.040.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the test material was determined to be a non irritant in accordance with EU criteria.
- Executive summary:
The potential of the test material to cause skin irritation was assessed in an in vitro study conducted under GLP conditions in accordance with the draft guideline “OECD Guideline for the Testing of Chemicals, Draft Proposal for a New Guideline, In Vitro Skin Irritation: Reconstructed Human Epidermis (RhE) Test Method, Version 4, 11 December 2009”.
The study used the EpiDerm reconstituted skin membranes. The undiluted test material was applied topically to the skin membranes for 60 minutes. After a 42 hour incubation period, the effect on the tissue viability was determined, based on the reduction of MTT to a purple formazan precipitate. 5 % Sodium Dodecyl Sulphate (SDS) was used as the positive control and Phosphate Buffered Saline (PBS) as the negative.
The mean optical density of the test material was 94 % of the negative control.
The optical densities of the negative and positive control were within the acceptable ranges and correctly indicated non irritancy and irritancy, respectively. This demonstrated validity of the model.
Under the conditions of this study, the test material was determined to be a non irritant and requires no classification in accordance with EU criteria.
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.