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EC number: 309-629-8 | CAS number: 100545-48-0
- 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 corrosion: in vitro / ex vivo
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 25 September 2012 to 04 October 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Octadecanoic acid, 12-hydroxy-, reaction products with ethylenediamine
- EC Number:
- 309-629-8
- EC Name:
- Octadecanoic acid, 12-hydroxy-, reaction products with ethylenediamine
- Cas Number:
- 100545-48-0
- Molecular formula:
- No discrete molecular formula available for this UVCB substance
- IUPAC Name:
- Reaction products of 12-hydroxyoctadecanoic acid with ethane-1,2-diamine
- Test material form:
- solid: particulate/powder
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: EpiskinTM Model Kit (0.38 cm2 tissues)
- Cell source:
- other: SkinEthic Laboratories, Lyon, France
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- TEST SYSTEM
- Species: human reconstructed epidermis (tissues).
- Supplier: SkinEthic Laboratories, Lyon, France.
- Selection: at receipt, the medium quality and temperature indicators were checked to ensure the good quality of the tissues before use.
- Storage conditions: the living tissues were kept at room temperature from receipt until the end of the in vitro phase.
- Description: the EpiskinTM model consists of an airlifted, living, multilayered epidermal tissue construction (surface 0.38 cm2), reconstituted from normal human epidermal keratinocytes for 13 days and produced in polycarbonate inserts in a serum-free and chemically defined medium. The model features a normal ultra structure and is functionally equivalent to human in vivo epidermis.
REMOVAL OF TEST SUBSTANCE
For all treated tissues (test item-treated, positive and negative controls), at the end of the designated incubation period, each tissue insert was removed from the well of the treatment plate and rinsed with Phosphate Buffered Saline Dulbeccos (PBS).
Rinsing was achieved by gently filling and emptying each tissue insert 12 times with 2 mL PBS to gently remove any residual dosage form. As the dose formulation adhered to the walls of the compartment, it was eliminated using a cotton bud.
POSITIVE CONTROL
Name: glacial acetic acid.
NEGATIVE CONTROL
Name: 0.9% NaCl.
SCORING SYSTEM:
- Optical density (OD) was measured at 540 nm:
Relative mean viability (%) = 100 x mean OD(test item) / mean OD(negative control)
DECISION CRITERIA
see table 7.3.1/1 in Any Other Information on Materials and Methods - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- Amount/concentration applied
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 20 mg +/- 2 mg per tissue.
The test item was spread over the whole tissue surface without damaging the tissue sample.
As the test item was a solid, 100 µL of 0.9% NaCl were applied over the test item to ensure good contact with the epidermis. - Duration of treatment / exposure:
- Duplicate tissues were treated with the test material for exposure periods of 3, 60 and 240 minutes (duplicate tissues were treated with the positive
and negative control materials for an exposure period of 240 minutes). - Duration of post-treatment incubation (if applicable):
- MTT-loading after a 3h-incubation period following rinsing. Observation of MTT-> formazan transformation by viable cells
- Number of replicates:
- 2
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- exposure duration: 3 minutes
- Value:
- 86
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- exposure duration: 60 minutes
- Value:
- 79
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- exposure duration: 240 minutes
- Value:
- 104
Any other information on results incl. tables
Following the 3, 60 and 240 minute exposure periods the test material treated tissues appeared blue which was considered to be indicative of viable tissue.
The relative mean tissue viability for the positive control treated tissues was 3% relative to the negative control treated tissues following the
240-Minute exposure period. The positive control acceptance criterion was therefore satisfied.
The mean OD value for the negative control was 0.232. The negative control acceptance criterion was therefore satisfied.
Table 7.3.1/2 Mean OD Values and viabilities for the negative and positive controls and the test item
Group |
Exposure duration |
OD570 nm |
Viability (%) |
||
|
|
Mean |
SD |
Mean |
SD |
Negative control |
240 min |
0.232 |
0.000 |
100 |
0 |
Positive control |
240 min |
0.006 |
0.001 |
3 |
0 |
Test item |
3 min |
0.199 |
0.002 |
86 |
1 |
60 min |
0.184 |
0.010 |
79 |
4 |
|
240 min |
0.241 |
0.002 |
104 |
1 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the in vitro study, the test substance was considered to be non-corrosive to the skin.
- Executive summary:
The objective of this study was to evaluate the corrosive potential of the test substance using the Episkin reconstituted skin model. This study was conducted in compliance with OECD Guideline No. 431 and the principles of Good Laboratory Practice.
A preliminary test was performed to detect the ability of the test item to directly reduce MTT. Following the preliminary test, the skin corrosion potential of the test item was tested in the main test. The test item, and both negative and positive controls were applied on duplicate tissues and incubated at room temperature as follows: positive and negative controls for 240 minutes (± 5 minutes); test item for 3 minutes (± 5 seconds), 60 minutes (± 5 minutes) and 240 minutes (± 5 minutes). At the end of the designated incubation periods, each tissue was rinsed with phosphate Buffered Saline Dulbeccos. The cell viability was then assessed by means of the colourimetric MTT reduction assay and relative viability (%) calculated for each tissue relative to control tissues.
In the preliminary assay, the MTT solution colour did not turn blue/purple when compared to the negative control. The test item was presumed not to directly reduce MTT.
In the main test, the blue discolouration of the test item-treated tissues following the 3 , 60 and 240 minute exposure periods was representative of viable tissue. The relative mean viabilities of the test item-treated tissues were 86% , 79% and 104% of the negative control for the 3, 60 and 240 minutes exposure periods respectively.
The test item was considered to be non corrosive to the skin.
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