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EC number: 610-288-5 | CAS number: 462-20-4
- 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
Endpoint summary
Administrative data
Description of key information
A acute oral toxicity study according to OECD 401 is available.
The acute oral median lethal dose (LD50) in female rats was calculated to be 576 mg/kg bodyweight
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20.07.1999 - 20.08.1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent
- Age at study initiation:8-12 weeks
- Weight at main study initiation: 226 -245 g (males), 205 - 230 g (females)
- Fasting period: overnight immediately before dosing and for approx. 3-4 h after dosing
- Housing: in groups of up to five by sex in solid-floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum): free access to food ( Rat and Mouse Expanded Diet No. 1, Special Diets Services Limited, Witham, Essex, UK)
- Water (e.g. ad libitum): free access to drinking water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours continuous light and twelve hours darkness - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
- Doses:
- Range-finding study: 2000, 1000, 600, 500 and 250 mg/kg
Main study: 1000, 707, 500 mg/kg - No. of animals per sex per dose:
- Range-finding study: one male and one female per dose
Main study: five females per dose and additionaly five males for the 500 mg/kg dose group - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for deaths or overt signs of toxicity 1/2, 1, 2 and 4 hours after dosing and subsequently once daily for up to fourteen days. Individual bodyweights were recorded prior to dosing on Day 0 and on Day 7 and 14 or at death.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, gross lession, body weight, and other toxicological effects - Statistics:
- Using the mortality data obtained, the actual oral median lethal dose (LD50) and 95 % confidence limits of the test material were calculated using probit method of Finney D J `Probit Analysis´1971, Cambridge University Press.
- Preliminary study:
- Undiluted:
All animals were found dead during the day of dosing or one day after dosing. Clinical signs of toxicity noted were ataxia, clonic convulsions, hunched posture, lethargy, ptosis, decreased respiratory rate, laboured respiration, body tremors or occasional body tremors, vasodilation and splayed gait.
Test material formulation:
There were no deaths. Hunched posture was commonly noted. - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 576 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Deaths were noted one day after dosing.
- Clinical signs:
- other: Hunched posture was commonly noted in all groups. Incidents of lethargy were noted in animals treated with 707 or 1000 mg/kg. Additional incidents of systemic toxicity noted in animals treated with 707 mg/kg were pilo-erection, occasional body tremors and
- Gross pathology:
- Abnormalities noted at necropsy of animals that died during the study were haemorrhagic lungs, dark liver or patchy pallor of the liver, pale spleen, dark kidneys and sloughing of the non-glandular epithelium of the stomach. Scattered areas of white foci on the non-glandular epithelium of the stomach were noted at necropsy of one female and four male animals treated with 500 mg/kg that were killed at the end of the study. No abnormalities were noted at necropsy of all other animals that were killed at the end of the study.
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The LD50 of Lipoic Acid was determined to be 576 mg/kg bodyweight.
- Executive summary:
A study was performed to assess the acute oral toxicity of Dihydrolipoic Acid in the Sprague-Dawley CD strain rat. The method used was based was based on the recommendations of the OECD Guidelines for Testing of Chemicals No. 401 "Acute Oral Toxicity" and Method B.1 of Commision Directive 92/69/EEC.
Following a range-finding study, three groups of five fasted females were given a single oral dose of test material, as a solution in arachis oil BP at dose levels of 500, 707 and 1000 mg/kg bodyweight. A further group of five fasted males was similarly treated, at a dose level of 500 mg/kg bodyweight, to confirm that this sex was not markedly more sensitive to the test material. The surviving animals were observed for fourteen days after the day of dosing. All animals were subjected to gross pathological examination.
Deaths were noted one day after dosing. Clinical signs of toxicity noted were hunched posture, lethargy, pilo-errection, decreased rate, occasional body tremors and tiptoe gait. Surviving animals recovered two to five days after dosing.
Surviving animals showed expected gain in bodyweight during the study. Abnormalities noted at necropsy of animals that died during the study were haemorrhagic lungs, dark liver or patchy pallor of the liver, pale spleen, dark kidneys and sloughing of the non-glandular epithelium of the stomach. Scattered areas of white foci on the non-glandular epithelium of the stomach were noted at necropsy of one female and four male animals treated with 500 mg/kg that were killed at the end of the study. No abnormalities were noted at necropsy of all other animals that were killed at the end of the study.
The acute oral median lethal dose (LD50) and 95 % confidence limits of the test material were calculated by the probit method of Finney D J to be 576 (445 - 746) mg/kg bodyweight (female only)
Male animals were considered not to be markedly more sentitive to the test material than female animals.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 576 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
A study was performed to assess the acute oral toxicity of Dihydrolipoic Acid in the Sprague-Dawley CD strain rat. The method used was based was based on the recommendations of the OECD Guidelines for Testing of Chemicals No. 401 "Acute Oral Toxicity" and Method B.1 of Commision Directive 92/69/EEC.
Following a range-finding study, three groups of five fasted females were given a single oral dose of test material, as a solution in arachis oil BP at dose levels of 500, 707 and 1000 mg/kg bodyweight. A further group of five fasted males was similarly treated, at a dose level of 500 mg/kg bodyweight, to confirm that this sex was not markedly more sensitive to the test material. The surviving animals were observed for fourteen days after the day of dosing. All animals were subjected to gross pathological examination.
Deaths were noted one day after dosing. Clinical signs of toxicity noted were hunched posture, lethargy, pilo-errection, decreased rate, occasional body tremors and tiptoe gait. Surviving animals recovered two to five days after dosing.
Surviving animals showed expected gain in bodyweight during the study. Abnormalities noted at necropsy of animals that died during the study were haemorrhagic lungs, dark liver or patchy pallor of the liver, pale spleen, dark kidneys and sloughing of the non-glandular epithelium of the stomach. Scattered areas of white foci on the non-glandular epithelium of the stomach were noted at necropsy of one female and four male animals treated with 500 mg/kg that were killed at the end of the study. No abnormalities were noted at necropsy of all other animals that were killed at the end of the study.
The acute oral median lethal dose (LD50) and 95 % confidence limits of the test material were calculated by the probit method of Finney D J to be576 (445 - 746) mg/kg bodyweight (female only)
Male animals were considered not to be markedly more sentitive to the test material than female animals.
Justification for classification or non-classification
According to Regulation (EC) No. 1272/2008 a LD50 of 576 mg/kg bodyweight results in a classifcation as "Acute toxicity (oral) - Category 4; H302").
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