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EC number: 309-665-4 | CAS number: 100683-96-3
- 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:
- key study
- Study period:
- September 24, 2013
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Remarks:
- no major deviations only minor deviations that have no impact on results
- GLP compliance:
- yes
Test material
- Reference substance name:
- Carbohydrates and Sugars, hexitols, anhydro
- EC Number:
- 309-665-4
- EC Name:
- Carbohydrates and Sugars, hexitols, anhydro
- Cas Number:
- 100683-96-3
- IUPAC Name:
- 2-(1,2-dihydroxyethyl)oxolane-3,4-diol; hexahydrofuro[3,2-b]furan-3,6-diol
- Test material form:
- other: liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Diet: SDS/DIETEX STANRAB (P) SQC feed was available ad libitum.
- Water:Drinking water was available ad libitum in polycarbonate bottles with a stainless steel nipple. A specimen of water is sent approximately every 6 months to Laboratoire de la Touraine - ZA n°1 du Papillon - Rue de l0Aviation - 37210 Parçay-Meslay - France, for analysis. The criteria for acceptable levels of contaminants in the water supplied were within the limits of the analytical specifications.
-Housing: Observation was performed at the time of delivery of the animals and daily during the acclimatisation period. Animals were housed individually in cages of standard size. These cages were placed in an air-conditioned (15- 21°C) animal house kept at between 45 % and 65 % relative humidity (except during the cleaning slot) in which non-recycled filtered air is changed approximately 10-15 times per hour. These parameters are continuously recorded using a computerised acquisition system. The artificial day/night cycle was 12 hours light and 12 hours darkness with light on at 7.30 a.m.
- IN-LIFE DATES: Start of the study (signature of the study plan by the Study Director): 02 May 2013, Start of the experimental period: 06 May 2013, End of the experimental period: 16 May 2013.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 mL of "hydrate de carbone et sucres, hexitol, anhydro" LAB 4623 was applied to the skin of the right or the left flank region. The test item was applied to the selected area on the right or left flank of each animal. Adjacent surfaces of non-treated skin of each animal served as a control for the trial.
The test item was placed directly on the skin, over an area of approximately 6 cm² then covered with a non-irritating gauze square of the same surface area. This gauze square was protected by a pad consisting of a semi-occlusive micro-porous and non-allergenic dressing, held in place with a soft and aerated fastening system consisting of elastic, adhesive, hypoallergenic tape. The animals were fitted with this pad for the duration of the exposure period. At the end of the exposure period, the dressing was removed. Since the application of the test item induced a brown colouration, the application sites were rinsed using a waterlogged gauze and a control zone was also rinsed and served as control. The standard amounts applied were not adjusted to body weight. - Duration of treatment / exposure:
- 3 min, 1h, 4h on the skin for the first animal, 4h for the two others.
- Observation period:
- For the initial test in one animal, due to the colouration of the treatment sites, the application site was not examined immediately after the patch has been removed. One hour, 24 hours, 48 hours and 72 hours approximately after patch removal dermal reactions on the right or the left flank of each animal were graded and recorded.
- Number of animals:
- 3 females
- Details on study design:
- The rabbit was chosen because of its acceptance as a predictor of irritant/corrosive effects of chemicals in man and the recognition by regulatory authorities that this species is suitable for skin irritation studies.
The number of animals per group is the minimum number enabling an accurate assessment of the studied toxicological effect.
Approximately 24 hours before the test, fur was removed by closely clipping the dorsal area of the trunk of the animals (at least 14 cm x 5 cm). Care was taken to avoid abrading the skin, and only animals with healthy, intact skin were used.
Three test patches were applied sequentially to separate skin sites on the animal. The first patch was removed after three minutes. Since no serious skin reaction was observed, a second patch was applied at a different site and removed after one hour. Since the observations at this stage indicated that exposure could humanely be allowed to extend to four hours, a third patch was applied and removed after four hours and any responses were graded.
Since no corrosive effect was observed in the initial test, the irritant or negative response was confirmed using two additional animals, each with one patch, for an exposure period of four hours.
For the initial test in one animal, due to the colouration of the treatment sites, the application site was not examined immediately after the patch has been removed. One hour, 24 hours, 48 hours and 72 hours approximately after patch removal dermal reactions on the right or the left flank of each animal were graded and recorded.
At the end of the study, euthanasia of animals was performed by an overdose of sodium pentobarbital injected by the intravenous route. No necropsy was performed at the end of the study.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- The application of the test item induced a dark brown to black colouration of the application site due to the same colouration of the test item. The application site was rinsed using a waterlogged gauze.
There was no cutaneous lesion in any animal at all times of examination.
Mean Indices were 0 in 3 out of 3 animals, therefore Mean Index of erythema and oedema was 0. - Other effects:
- There was no change in body weight gain between D1 and D4.
Any other information on results incl. tables
Acute skin lesions - Individual scores - Test item - Local observations
Clinical signs (range of scores; normal score)
|
Time |
Animal serial number |
||||
Erythema and eschar (0-4 ;0) |
Timmediate |
1 |
2 |
3 |
4 |
5 |
T 1H |
NE |
NE |
NE |
NE |
NE |
|
T 24H |
0 |
0 |
0 |
0 |
0 |
|
T 48H |
0 |
0 |
0 |
0 |
0 |
|
T 72H |
0 |
0 |
0 |
0 |
0 |
|
Oedema (0-4 ;0) |
T 1H |
0 |
0 |
0 |
0 |
0 |
T 24H |
0 |
0 |
0 |
0 |
0 |
|
T 48H |
0 |
0 |
0 |
0 |
0 |
|
T 72H |
0 |
0 |
0 |
0 |
0 |
NE: not evaluable.
Mean Index (M.I.)
Treatment |
Animal number |
Erythema |
Oedema |
Test item |
130407- T 3MIN |
0 |
0 |
Test item |
130407- T 1H |
0 |
0 |
Test item |
130407- T 4H |
0 |
0 |
Test item |
130408 - T 4H |
0 |
0 |
Test item |
130409 - T 4H |
0 |
0 |
Effect on body weight (individual values)
Treatment |
Animal number
|
D1 |
D4
|
Test item |
130407 |
1.898 |
2.040
|
Test item |
130408 |
2.397 |
2.380
|
Test item |
130409 |
2.120 |
2.360
|
Results expressed in kg
D: Day
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Under the experimental conditions adopted, "hydrate de carbone et sucres, hexitol, anhydro" LAB 4623 (Batch No. SMOU/13/06) was found to be non irritant for the skin of the rabbit.
Classification according to Council Directive No. 67/548/EEC and subsequent amendments and CLP Regulation No. 1272/2008:
Symbol: none is required.
Indication of danger: none is appropriate.
Risk phrase: none is applicable. - Executive summary:
The aim of the study was to determine any irritant property and/or degree of corrosion of "hydrate de carbone et sucres, hexitol, anhydro" LAB 4623 (Batch No. SMOU/13/06) in the rabbit following a single semi-occluded application to intact skin in accordance with General Requirements of O.E.C.D Guideline No. 404 (April 24, 2002), method B4 of Commission Directive No. 2004/73/EC (April 29, 2004) adapting to technical progress for the 29th Council Directive No. 67/548/EEC and
subsequent amendments and of Council Regulation No. 440/2008 (30th May 2008) and Regulation No. 1907/2006 (REACH).
Three animals were used for the study.
0.5 mL of test item was applied on the skin.
Semi-occlusive dressings held the test item in place for 3 minutes, 1 hour and 4 hours on the skin of the first animal and for 4 hours for the two other animals.
Any cutaneous lesion was evaluated approximately one hour, 24, 48 and 72 hours after removal of the dressing.
Mean indices were calculated from results obtained from each rabbit at times 24, 48 and 72 hours.
The application of the test item induced a brown colouration of the application site. The application site was rinsed using a waterlogged gauze.
There was no cutaneous lesion in any animal at all times of examination.
Mean Index of erythema and oedema was 0.
There was no change in body weight gain.
Conclusion: Under the experimental conditions adopted, "hydrate de carbone et sucres, hexitol, anhydro" LAB 4623 was found to be non irritant for the skin of the rabbit. Substance was not classificied according to Council Directive No. 67/548/EEC and subsequent amendments and CLP Regulation No. 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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