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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
- 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
Immunotoxicity
Administrative data
- Endpoint:
- immunotoxicity, other
- Remarks:
- Day 1: i.p.; Day 22: i.v.
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 11/1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Study owner prepared study while seeking authorisation of the substance as active incredient for medical treatment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: EEC guidelines
- GLP compliance:
- yes
Test material
- Reference substance name:
- 5-(dithiolan-3-yl)valeric acid
- EC Number:
- 214-071-2
- EC Name:
- 5-(dithiolan-3-yl)valeric acid
- Cas Number:
- 1077-28-7
- Molecular formula:
- C8H14O2S2
- IUPAC Name:
- 5-(1,2-dithiolan-3-yl)pentanoic acid
- Reference substance name:
- unknown
- IUPAC Name:
- unknown
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- dihydrogen oxide
- Test material form:
- solid: bulk
- Details on test material:
- This composition is the usual techical grade of AlzChem AG. It will be used when test substance has this composition (or is very closed) or no specific information is available
Constituent 1
impurity 1
impurity 2
- Specific details on test material used for the study:
- 10 ampoules à 10 ml (25 mg/ml alpha-Lipoic acid)
One part stored at room temperature
One part stored at -14 °C to -16 °C (max. -18 °C) for 4 weeks before application and then allowed to reach room temperature over a period of approximately 4 h on the day of application.
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- B.w.: 362 - 475 g
Age: 70 d on day of application
Housing: MAKROLON-cages (type III)
Room temperature: 21 °C +/- 2 °C
Relative humidity: 50 % +/- 10 %
Illumination: 150 lux at 1.5 m room height
Darkness: 12 h/d
Bedding: Granulated textured wood
Food: ALTROMIN 3022 (Standard Diet for Guiea Pigs), ad libitum
Water: ad libitum
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- not specified
- Details on exposure:
- Day 1: i.p. injection
Day 22: iv injection
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 other: ml/kg bw
- Dose / conc.:
- 0.86 other: ml/kg bw
- No. of animals per sex per dose:
- 7 m: 1 ml/kg bw horse serum
7 m: 1 ml/kg bw horse serum + test item stored at rt
7 m: test item stored at rt
7 m: 1 ml/kg bw horse serum + test item stored in freezer
7 m: test item stored in freezer - Control animals:
- yes
- Details on study design:
- Day 1: injection of the test item i.p.
Day 22: injection ot the test item i.v.
In case of no observations: injection of 1 ml/kg bw hores serum i.v., one animal per group
Examinations
- Observations and clinical examinations performed and frequency:
- Signs of anaphylactic shock:
- licking nose or rubbing the nose with forefeet
- ruffling of fur
- laboured breathing
- sneezin or coughing (tree or more times)
- retching
During i.v. administration and for 15 min following the injection.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- no animal showed any sings of an anaphylactic shock after i.p. administration of the test item on day 22.
One animal of each group was treated with horse serum (1 ml/kg bw) on day 22: animals who recieved horse serum on day 1 immediatly showed signs of an anaphyactic shock (rubbing the nose, laboured breathing, convulsions and death). - Dermal irritation (if dermal study):
- not examined
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- 3 animals who recieved horse serum on day 1 and day 22 died.
- Body weight and weight changes:
- not examined
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
Specific immunotoxic examinations
- Cell viabilities:
- not examined
- Humoral immunity examinations:
- not examined
- Specific cell-mediated immunity:
- not examined
Effect levels
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- >= 0.86 other: ml/kg bw
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- clinical signs
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Applicant's summary and conclusion
- Conclusions:
- Single administration of alpha-Lipoic acid does not lead to sensitisation.
- Executive summary:
Under the present test conditions, i.p. administration of 0.86 ml/kg bw alpha-Lipoic acid, either with or without concurrent administration of horse serum, did not possess any sensitising properties; ie. no positive sings of anaphylaxis were observed following i.v. administration of alpha-Lipoic acid on test day 22.
In this experiment, no differences were evident between the aninmals treated with alpha-Lipoic acid wich had been stored at rt and alpha-Lipoic acid wich had been stored at -14 °C to -16 °C for 4 weeks before application and then allowed to reach rt over a period of approx. 4 h on the day of application.
The sensitivity of the animals was tested by i.v. application of horse serum th one animal per group. This resulted in immediate signs of anaphylactic shock (rubbing the nose, laboured breathin, convulsions and death) in the animals wich had recieved horse serum (groups 1, 2 and 4). No effect was observed in the animals in groups 3 and 5.
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