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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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EC number: - | CAS number: -
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014-08-19 to 2014-08-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- (July 26, 2013)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- (July 20, 2012)
- GLP compliance:
- yes
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- other: EPISKIN Small Model (TM)
- Details on test animals or test system and environmental conditions:
- TEST SYSTEM
- Test system: EPISKIN-SM (TM), 0.38 sq.cm, Lot no.: 14-EKIN-031
- Source: SkinEthic Laboratories, Lyon, France
- Acclimation period: preincubated for 26 h at 37°C in 12-well plates
MTT MEDIUM
- MTT concentrate 3 mg/mL in PBS diluted (10x) in Assay medium (final concentration 0.3 mg/mL)
- Source: Sigma Aldrich, Zwijndrecht, The Netherlands
ENVIRONMENTAL CONDITIONS DURING APPLICATION
- Temperature (°C): room temperature
ENVIRONMENTAL CONDITIONS DURING POST-TREATMENT INCUBATION
- Temperature (°C): 35.6-37.5 (continuously monitored)
- Humidity (%): 65-87 (continuously monitored)
- Other: CO2 content: 5.0 +/- 0.5% (monitored once daily on work days)
Test system
- Type of coverage:
- open
- Preparation of test site:
- other: no treatment
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: control tissues
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10.3 to 13. 0 mg
NEGATIVE CONTROL (NC)
- Substance: Phosphate buffered saline (PBS)
- Source: Invitrogen Corporation, Breda, The Netherlands
- Amount(s) applied (volume or weight with unit): 25 µL
POSITIVE CONTROL (PC)
- Substance: 5% (aq) Sodium dodecyl sulphate (SDS) in PBS
- Source: Sigma Aldrich, Zwijndrecht, The Netherlands)
- Amount(s) applied (volume or weight with unit): 25 µL and re-spread after 7 min contact time - Duration of treatment / exposure:
- 15 min
- Observation period:
- - Single obeservation after 45 h (Post-treatment incubation time 42 h; Incubation time in MTT-medium 3h)
- Number of animals:
- 3 tissues each per test substance, negative and positive controls.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): all tissues were washed with PBS
- Time after start of exposure: 15 min
- Other: after rinsing all cell culture inserts were dried, moved to new well and incubated for 42 h at 37°C (post-treatment incubation)
OTHER: CELL VIABILITY MEASUREMENT
conducted after post-treatment incubation
- MTT incubation: cultured and dried inserts transferred to new plates with 2 mL MTT-medium (0.3 mg/mL) and incubated (3h at 37°C)
- Epidermis extraction: after MTT incubation tissues were dried on blotting paper; then epidermis was extracted with 500 µL isopropanol, then stored refrigerated in tubes for 72 h in darkness
- Formazan determination: spectrophotometrically at 570 nm in duplicate with the TECAN Infinite® M200 Pro Plate Reader
SCORING SYSTEM
- Cell viability: calculated for each tissue as percentage of the negative control mean
- Skin irritation potential: according to remaining cell viability
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: other: mean tissue viability
- Value:
- 102
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Remarks: 102 % of negative control. (migrated information)
Any other information on results incl. tables
Table 1 Mean absorption and tissue viability in the in vitro skin irritation test with Lithium salt of branched-aliphatic dicarboxylic acid
|
A (OD570) |
B (OD570) |
C (OD570) |
Mean (OD570) |
SD |
Mean tissue viability (percentage of control) |
Negative control |
1.069 |
1.057 |
1.047 |
1.058 |
+/- 0.011 |
100 |
Test substance |
1.057 |
1.098 |
1.084 |
1.079 |
+/- 0.021 |
102 |
Positive control |
0.371 |
0.245 |
0.657 |
0.425 |
+/- 0.211 |
40 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The relative mean tissue viability obtained after 15 minutes treatment with Lithium salt of branched-aliphatic dicarboxylic acid compared to the negative control tissues was 102%. Since the mean relative tissue viability for Lithium salt of branched-aliphatic dicarboxylic acid was above 50% after 15 minutes of treatment Lithium salt of branched-aliphatic dicarboxylic acid is considered to be non-irritant.
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.
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