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EC number: 214-071-2 | CAS number: 1077-28-7
- 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
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- Nanomaterial pour density
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- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
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- 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
Endpoint summary
Administrative data
Description of key information
Two in vitro tests were perfomred to assess the skin irritation / corrosion potential of alpha-Lipoic acid.
The Bovine Cornea Opacity and Permeability assay was perfomred to assess the eye irritation / corrosion potential of alpha-Lipoic acid.
On Reconstructed Human Epidermis (RHE, EpiDerm) the test item showed no corrosive but irritating effects.
With the the BCOP-assay no predictiction can be made about effects of the test item on the eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-01-04 - 2017-02-23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- 2016-07-29
- GLP compliance:
- yes (incl. QA statement)
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: NHEC: normal human-derived epidermal keratinocytes
- Justification for test system used:
- The EpiDerm(TM) Skin Model is a well established organotypic, three-dimensional model of the human epidermis and is used for in vitro experiments many years. It is known for its similaryty to huaman skin.
- Vehicle:
- water
- Details on test system:
- The test was carried out with the reconstituted three-dimensional human skin model EpiDerm(TM) (MatTek). This skin model consists of normal human epidermal keratinocytes (NHEK) which have been cultured to form a multilayered, highly differentiated model of the human epidermis. The NHEK are cultured on chemically modified, collagen-coated cell culture inserts (Millicell(R)). The EpiDerm(TM) epidermis model exhibits in vivo-like morphological and growth characteristics which are uniform and highly reproducible. It consists of organised basal, spinous and granular layers and a multi-layered stratum corneum analogous to patterns found in vivo.
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- Negative control: 50 µL distilled Water
Positive control: 50 µL 8 N KOH
Test Item: 25 mg + 25 µL H2O - Duration of treatment / exposure:
- 3 min; 60 min
- Number of replicates:
- 4 per dose group
2 repliocates for each treatment period - Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min
- Value:
- ca. 97.5
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 min
- Value:
- ca. 77.5
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- other: not corrosive
- Conclusions:
- In the study under the given conditions the test item showed no corrosive effects. The test item is classified as "non-corrosive".
- Executive summary:
In the present study the skin corrosivity of Thioctic Acid was analysed. Since corrosive chemicals are cytotoxic after a short tim exposure to the stratum corneum of the epidermis the cytotoxic effects of the test item on EpiDerm(TM), a reconstituted three-dimensional human epidermis model, were determined. Hereby, the test item was applied topically. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogensase activity measured by formazan production from MTT after a 3 min and 60 min exposure period and compared to those of the concurrent negative controls.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-03-17 - 2017-05-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 2015-07-06
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- 2012-07-06
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: NHEC: normal human-derived epidermal keratinocytes
- Justification for test system used:
- This test uses the EpiDerm™ reconstructed human epidermis model (MatTek) which consists of normal human epidermal keratinocytes (NHEK) and therefore represents in vitro the target organ of the species of interest and closely mimics the biochemical and physiological properties of the upper parts of the human, i.e. the epidermis.
- Vehicle:
- physiological saline
- Remarks:
- DPBS: Dulbecco’s phosphate buffered saline
- Details on test system:
- The test was carried out with the reconstituted three-dimensional human skin model EpiDerm(TM) (MatTek). This skin model consists of normal human epidermal keratinocytes (NHEK) which have been cultured to form a multilayered, highly differentiated model of the human epidermis. The NHEK are cultured on chemically modified, collagen-coated cell culture inserts (Millicell(R)). The EpiDerm(TM) epidermis model exhibits in vivo-like morphological and growth characteristics which are uniform and highly reproducible. It consists of organised basal, spinous and granular layers and a multi-layered stratum corneum analogous to patterns found in vivo.
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- Negative control: 30 µL DPBS
Positive Control: 30 µL 5% SDS solution
Test Item: 25 mg + 25 µL DPBS - Duration of treatment / exposure:
- 60 min (35 min in the incubator -> 37 °C, 5 % CO2; 25 min under sterile flow)
- Duration of post-treatment incubation (if applicable):
- 42 h (24 h in the incubator -> 37 °C, 5 % CO2, 95 % humidity; 18 h under same conditions, but in new wells with fresh assay medium)
- Number of replicates:
- 3
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- ca. 22
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- In this study under the given conditions the test item showed irritant effects. The relative mean tissue viability after 60 min of exposure and 42 h post-incubation was ≤ 50%. The test item is therefore classified as “irritant” in accordance with UN GHS “Category 2”.
- Executive summary:
In the present study the skin irritant potential of Thioctic Acid was analysed. The EpiDerm™-Standard Model (EPI-200™), a reconstituted three-dimensional human epidermis model, was used as a replacement for the Draize Skin Irritation Test (OECD TG 404, [7]) to distinguish between UN GHS “Category 2” skin irritating test substances and not categorized test substances (“No Category”) which may be considered as non-irritant. Hereby, the test item was applied topically. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT after a 60 min exposure and 42 h post-incubation period and compared to those of the concurrent negative controls.
The test item showed irritant effects. The mean relative tissue viability (% negative control) was ≤ 50% (22%) after 60 min treatment and 42 h post-incubation.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-01-20 - 2017-03-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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)
- Deviations:
- yes
- Remarks:
- Phenol red free RPMI 1640 medium instead of phenol red free EMEM
- GLP compliance:
- yes (incl. QA statement)
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- The Assay uses isolated corneas obtained as a by-product from animals freshly slaughtered.
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- Negative control: physiological saline 0.9 % NaCl
Positive control: Imidazole 20 % in physiological saline 0.9 % NaCl
Test item: 20 % suspended in physiological saline 0.9 % NaCl - Duration of treatment / exposure:
- 4 h
- Number of animals or in vitro replicates:
- 3 corneas in each group
- Irritation parameter:
- in vitro irritation score
- Value:
- ca. 36.57
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Remarks:
- IVIS: 1.63
- Positive controls validity:
- valid
- Remarks:
- IVIS: 122.97
- Irritation parameter:
- cornea opacity score
- Value:
- ca. 36.54
- Vehicle controls validity:
- not examined
- Remarks:
- Corrected opacity: 0
- Negative controls validity:
- valid
- Remarks:
- Corrected opacity: 101
- Positive controls validity:
- valid
- Irritation parameter:
- fluorescein leakage
- Remarks:
- Corrected OD490
- Value:
- ca. 0.002
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- 1.462
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No prediction can be made regarding the classification of the test substance Thioctic Acid to the evaluation criteria. Further testing in another suitable method is to be done with tonnage band increase.
- Executive summary:
The eye irritancy potencial of Thioctic Acid was investigated in the bovine corneal opacity and permeability assay.
The test item was suspended with physiologicalsaline 0.9 % to give a 20 % concentration.
Mean in vitro irritation score: 36.57
Classification: No prediction can be made
The in vitro irritation score obtained with the positive control fell witin the two standard deviations of the current historical mean and therefore this assay is concidered to be valid.
The negative control responses should result in opacity and permeability values that are less the establisched upper limits for background bovine corneas treated with the respective negative control.
Reference
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
The relative mean tissue viability after 60 min of exposure and 42 h post-incubation was ≤ 50%. According to the CLP regulation the test item is therefore classified as “skin irritant" (UN GHS “Category 2”).
The IVIS obtained by the PCOP assay is 36.57. An IVIS between 3 and 55 can't be used for classification.
As alpha-Lipoic acid is classified as "skin irritant" (UN GHS "Category 2") it can be concluded it also may cause serious eye irritations (UN GHS "Category 2").
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