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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 21.07.1999 - 25.07.1999
- 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 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye 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 3
- Storage condition of test material: room temperature in the dark under nitrogen
Constituent 1
Constituent 2
Constituent 3
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12 to 16 weeks old
- Weight at study initiation: 2.78 kg
- Housing: housed in a suspended metal cage
- Diet: ad libitum, Stanrab SQC Rabbit Diet, Special Diets Services, Witham, Essex, UK
- Water: ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23 °C
- Humidity (%): 30 -70 %
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): twelve hours light and twelve hours darkness
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0,1 mL of the test substance - Duration of treatment / exposure:
- no data
- Observation period (in vivo):
- The animal was killed for humane reasons four days after treatment. An additional observation was performed immediately prior to termination.
- Number of animals or in vitro replicates:
- one male
- Details on study design:
- SCORING SYSTEM: Draize Scale for Scoring Ocular Irrritation
1. CONJUNCTIVAE
a) Redness (refers to palpebral and bulbar conjunctivae exluding cornea and iris)
0: Vessels normal
1: Vessels definitely injected above normal
2: More diffuse, deeper crimson red, individual vessels not easily discernible
3: Diffuse beefy red
b) Chemosis
0: No swelling
1: Any Swelling above normal (includes nictitating membrane)
2: Obvious swelling with partial eversion of lids
3: Swelling with lids about half closed
4: Swelling with lids half closed to completely closed
c) Discharge
0: No discharge
1: Any amount different from normal (does not include small amounts observed in inner canthus of normal animals)
2: Discharge with moistening of the lids and hairs just adjacent to lids
3: Discharge with moistening of the lids and hairs a considerable area around the eye
THE TOTAL SCORE = (A + B + C) x 2 MAXIMUM TOTAL = 20
2. IRIS
d) Values
0: Normal
1: Folds above normal, congestion, swelling, circumcorneal injection (any or all of these or combination of any thereof) iris still reacting to light (sluggish reaction is positive
2: No reaction to light, haemorrhage, gross destruction (any or all of these)
THE TOTAL SCORE = D x 5 MAXIMUM TOTAL = 10
3. CORNEA
e) Degree of Opacity (most dense area used)
0: No opacity
1: Scattered or diffuse areas, details of iris clearly visible
2: Easily discernible translucent areas, details of iris slightly obscured
3: Opalescent areas, no details of iris visible, size of pupil barely discernible
4: Opaque, iris not discernible through the opacity
f) Area of Cornea Involved
1: One quarter (or less) but not zero
2: Greater than one quarter but less than half
3: Greater than half but less than three quarters
4: Greater than three quarters, up to whole area
THE TOTAL SCORE = (E x F) x5 MAXIMUM TOTAL = 80
MAXIMUM TOTAL SCORE POSSIBLE = 100
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- >= 30 - <= 40
- Max. score:
- 40
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- >= 5
- Max. score:
- 5
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- >= 14 - <= 16
- Max. score:
- 16
- Reversibility:
- not specified
Any other information on results incl. tables
Interpretation of Results (Classification According to a Modified Version of the Kay and Calandra System):
The numerical values corresponding to the tissue and observation time were recorded. The data relating to the conjunctivae were designated by the letter A (redness), B (chemosis) and C (discharge), those relating to the iris designated by the letter D and those relating to the iris designated by the letter E (degree of opacity) and F (area of opacity). For each tissue the score was calculated as follows:
Score for conjunctivae = (A+B+C) x 2
Score for iris = Dx5
Score for cornea = (ExF) x 5
Using the numerical data obtained a modified version of the system described by Kay J H and Calandra J C, J. Soc. Cosmet. Chem., 1962 13 281- 289 was used to classify the ocular irritancy potential of the test material. This was achieved by adding together the scores for the cornea, iris and conjunctivae for each time point. The total score enabled assessment of the eye irritancy potential of the test material.
If the rabbit shows irriversible ocular damage the test material will be classified as corrosiv to the eye.
Results:
Individual and total scores for ocular irritation are give in Table 1.
Table 1: Indivídual and total scores for ocular irritation.
Rabbit Number and Sex (Bodyweight kg) |
IPR = 0 + |
||||
192 Male (2.78) |
|||||
Time after Treatment |
1 hour |
24 hours |
48 hours |
72 hours |
4 days K |
CORNEA E = Degree of Opacity F = Area of Opacity |
2 3 |
2SI 4 |
3SI* 4 |
3SI* 4 |
3SI* 4 |
Score (E x F) x 5 |
30 |
40 |
40 |
40 |
40 |
IRIS D |
1 |
1 |
1 |
1 |
1 |
Score (D x 5) |
5 |
5 |
5 |
5 |
5 |
CONJUNCTIVAE A = Redness B = Chemosis C = Discharge |
2 2 3 |
2AI 3 3 |
3AI 2 3 |
3AI 2 3 |
3AI 2 3 |
Score (A + B + C) x 2 |
14 |
16 |
16 |
16 |
16 |
Total Score |
49 |
61 |
81 |
81 |
81 |
IPR = initial pain reaction; AI = alopecia; SI = sloughing of the cornea; K = animal killed for humane reasons;
* = grade 3 opacity around lower outer edge of cornea with grade 1opacity over rest of cornea; + = one drop of Ophthaine instilled into both eyes 1 to 2 minutes before dosing
Translucent corneal opacity was noted in the treated eye one hour after treatment and at the 24 -hour observation with opalescent corneal opacity at the 48, 72- hour and 4 -day observations.
Iridial inflammation was noted in the treated eye one hour after treatment and at subsequent 24, 48, 72 -hour and 4 -day observations.
Moderate conjunctival irritation was noted in the treated eye one hour after treatment with severe conjunctival irritation at subsequent 24, 48, 72 and 4 -day observations.
Sloughing of the cornea was noted in the treated eye with alopecia around the treated eye at 24, 48, 72 -hour and 4 -day observations.
The animal was killed, for humane reasons four days after treatment.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Dihydrolipoic Acid produced a maximum total score of 81.0 and was considered to be at least a very severe irritant (Class 7 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system (based on one rabbit only).
- Executive summary:
In order to assess the irritancy potential of Dihydrolipoic Acid to the eye of the New Zealand White rabbit a study according to OECD 405 ("Acute Eye Irritation/Corrosion") and 92/69EEC B.5 was performed.
A single instillation of the test material to the non-irrigated eye of one rabbit produced opalescent corneal opacity, iridial inflammation and severe conjunctival irritation. Sloughing of the cornea and alopecia were also noted. The animal was killed for humane reasons four days after treatment. In the test Dihydrolipoic Acid produced a maximum total score of 81.0 and was considered to be at least a very severe irritant (Class 7 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system (based on one rabbit only).
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