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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 24.06.1999 - 20.07.1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 6,8-disulfanyloctanoic acid
- IUPAC Name:
- 6,8-disulfanyloctanoic acid
- Reference substance name:
- 6,8-disulfanyloctanoic acid
- Cas Number:
- 462-20-4
- Molecular formula:
- C8H16O2S2
- IUPAC Name:
- 6,8-disulfanyloctanoic acid
- Reference substance name:
- 6,8-disulfanyloctanoic acid
- EC Number:
- 610-288-5
- Cas Number:
- 462-20-4
- Molecular formula:
- C8H16O2S2
- IUPAC Name:
- 6,8-disulfanyloctanoic acid
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): Dihydrolipoic Acid
- Physical state: liquid
- Lot/batch No.: TC 3 KD
- Storage condition of test material: room temperature in the dark, under nitrogen
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12- 16 weeks
- Weight at study initiation: 2.55 - 282 kg
- Housing: individually in suspended metal cages
- Diet: ad libitum; Stanrab SQC Rabbit Diet, Special Diets Services Ltd, Witham, Essex, UK
- Water: ad libitum
- Acclimation period: minimum five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23 °C
- Humidity (%): 30 -70 %
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12 hours continous light and 12 hours darkness.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0,5 mL of the test substance - Duration of treatment / exposure:
- three time points: 3 minutes, 1 hour and 4 hours
- Observation period:
- 14 days
- Number of animals:
- three males
- Details on study design:
- TEST SITE
- Area of exposure: dorsal flank area
- Type of wrap if used: elasticated corset (TUBIGRIP)
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4hours
SCORING SYSTEM:
Draize J H (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p.31.
Erythema and Eschar Formation:
0: No erythema
1: Very slight erythema (barely perceptible)
2: Well-defined erythema
3: Moderate to severe erythema
4: Severe erythema (beet redness) to slight eschar formation (injuries in depth)
Oedema Formation:
0: No oedema
1: Very slight oedema (barely perceptible)
2: Slight oedema (edges of area well-defined by definite raising)
3: Moderate oedema (raised approximately 1 millimeter)
4: Severe oedema (raised more than 1 millimeter and extending beyond the area of exposure
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 6
- Max. score:
- 6
- Reversibility:
- not specified
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- >= 6
- Max. score:
- 6
- Reversibility:
- not specified
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- >= 5
- Max. score:
- 5
- Reversibility:
- not specified
- Remarks on result:
- probability of moderate irritation
Any other information on results incl. tables
Interpretation of Results (Calculation of Primary Irritation Index and Grading of the Irritancy Potential Using Draize Scheme):
The score of the erythema and oedema at the 24 and 72 -hour readings (4 -hour exposure) were totalled for the three rabbits (12 values) and this total was divided by six to give the primary irritation index of the test material. The test material was classified according to the following scheme devised by Daize J H (1959) "Dermal Toxicity" In: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. Association of Food and Drug Officials of the United States, Austin, Texas, p. 47.
Primary Irritation Index: Classification of Irritancy:
0 Non-irritant
> 0 to 2 Mild irritant
> 2 to 5 Moderate irritant
> 5 to 8 Severe irritant
Results of 4 -hour exposure period:
Table 1: The individual scores for erythema/eschar and oedema of the 4 -hour exposure period.
Skin Reaction |
Observation Time |
Individual Scores - Rabbit Number, Sex and Bodyweight |
Total |
||
134 Male (2.82 kg) |
1 Male (2.55 kg) |
2 Male (2.64 kg) |
|||
Erythema/Eschar Formation |
1 hour |
2 (N) |
3 |
2 |
(7) |
24 hours |
2 (N) |
2 |
2 |
6 |
|
48 hours |
2 (N) |
2 |
2 |
(6) |
|
72 hours |
2 LeLf(N) |
2 Le |
1 Le |
5 |
|
7 days |
0 Cf(Sp) |
0 Cf |
0 D |
(0) |
|
14 days |
0 Fr(G) |
0 |
0 |
(0) |
|
Oedema Formation |
1 hour |
3 |
3 |
3 |
(9) |
24 hours |
3 Oe |
3 |
2 |
8 |
|
48 hours |
2 |
2 |
2 |
(6) |
|
72 hours |
2 |
2 |
1 |
5 |
|
7 days |
0 |
0 |
0 |
(0) |
|
14 days |
0 |
0 |
0 |
(0) |
|
Sum of 24 and 72-hour readings (S) |
24 |
||||
Primary Irritation Index (S/6) |
24/6 = 4.0 |
||||
Classification |
Moderate Irritant |
( ) = Total values not used for calculation of primary irritation index
Cf = Crust formation
D = slight desquamation
Fr = reduced regrowth of fur
(G) = glossy skin where necrosis and straw-coloured scabbing previously located
Le = loss of skin elasticity
Lf = loss of skin flexibility
(N) = narrow margin of green-coloured dermal necrosis (approx. 2 mm wide) running along bottom edge of treatment side. Grade 2 erythema present over treated area
Oe = oedema extending ventrally below treatment site
(Sp) = area of straw-coloured scabbing where necrosis previously located
Results of the 1 -hour exposure period:
Table 2: The individual scores for erythema/eschar and oedema of the 1 -hour exposure period.
Skin Reaction |
Observation Time |
Individual Scores - Rabbit Number, Sex and Bodyweight |
|
134 Male (2.82 kg) |
|||
3-minute exposure |
1-hour exposure |
||
Erythema/Eschar Formation |
1 hour |
0 |
0 |
|
24 hours |
0 |
2 |
|
48 hours |
0 |
2 |
|
72 hours |
0 |
2 Le |
|
7 days |
0 |
0 Cf |
|
14 days |
0 |
0 |
Oedema Formation |
1 hour |
0 |
0 |
|
24 hours |
0 |
2 |
|
48 hours |
0 |
1 |
|
72 hours |
0 |
1 |
|
7 days |
0 |
0 |
|
14 days |
0 |
0 |
Cf = crust formation
Le = loss of skin elasticity
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Dihydrolipoic Acid produced a primary irritation index of 4.0 and was classified as a moderate irritant to rabbit skin according to the Draize classification scheme.
- Executive summary:
A study (according to OECD 404 and 92/69/EEC B.4) was performed to assess the irritancy potential of Dihydrolipoic Acid to the skin of the New Zealand White rabbit.
A single 4 -hour, semi-occluded application of the test material to the intact skin of three rabbits produced well-defined to moderate to severe erythema and moderate oedema. A thin margin of green-coloured dermal necrosis (approx. 2 mm wide) was noted adjacent to the lower edge of one treatment site with loss of skin elasticity and flexibility, crust formation, reduced regrowth of fur, an area of straw-coloured scabbing, glossy skin and oedema extending ventrally below the treatment site were also noted. Two treated skin sites appeared normal at the 14 -day observation. No evidence of full thickness tissue destruction was noted. 3 -minute and 1 -hour semi-occluded applications of the test material to the intact skin of one rabbit produced no corrosive effects.
Dihydrolipoic Acid produced a primary irritation idex of 4.0 and was classified as a moderate irritant to rabbit skin according to the Draize classification scheme.
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