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Diss Factsheets
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EC number: - | CAS number: -
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 02, 2021
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- Some time points of the temperature in animal room and some animals' age deviated from the study plan. But the deviations were small, and animals showed no abnormalities during the study, it was considered not to affect the animals and study results.
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- an appropriate Buehler test is available
Test material
- Reference substance name:
- Enzymatically produced steviol glycosides
- IUPAC Name:
- Enzymatically produced steviol glycosides
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 80% ethanol solution
- Concentration / amount:
- 0.2 g
- Day(s)/duration:
- On Day 0 (first induction date), Day 7 and Day 14
- Adequacy of induction:
- other: For no irritation was found in the preliminary irritation test, about 0.2g test item was directly selected for both induction and challenge.
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Acetone
- Concentration / amount:
- 0.2 g
- Day(s)/duration:
- On day 28
- Adequacy of challenge:
- other: For no irritation was found in the preliminary irritation test, about 0.2g test item was directly selected for both induction and challenge.
- No. of animals per dose:
- Preliminary irritation group (2 animals): 18, 30
Control group (10 animals): 24, 9, 3, 26, 7, 16, 11, 4, 8, 12
Treated group (20 animals): 25, 2, 28, 13, 6, 29, 27, 17, 14, 21, 20, 10, 5, 19, 22, 31, 15, 1, 32, 23 - Positive control substance(s):
- yes
- Remarks:
- Name:α-Hexylcinnamaldehyde Molecular formula:C15H20O Molecular weight:216.32 g/mol CAS No.:101-86-0
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.2g test item (moistened with 0.2ml vehicle)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No visible change in skin reactions (erythema and / or swelling) were found on the right treated skin of each animal in the control animals and treated animals observed at 24h and 48h observation after the patch was removed and the scores were all 0.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.2g test item (moistened with 0.2ml vehicle)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No visible change in skin reactions (erythema and / or swelling) were found on the right treated skin of each animal in the control animals and treated animals observed at 24h and 48h observation after the patch was removed and the scores were all 0.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- no data
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Clinical observations:
- Severity index=0.35, Incidence=30%
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- no data
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Clinical observations:
- Severity index=0.35, Incidence=30%
- Remarks on result:
- positive indication of skin sensitisation
- Group:
- negative control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
1 Preliminary test phase
No visible change in skin reactions were found on the treated skin area of each animal observed in the morning of the next day. So about 0.2g test item (moistened with 0.2ml vehicle)was used in the induction phase and about 0.2g test item (moistened with 0.2ml vehicle) were used in the challenge phase.
2 Induction phase
No visible change in skin reactions (erythema and / or swelling) were found on the treated skin during the first, second and third induction phases at 24h and 48h observation after the patch was removed and the scores were all 0.
3 Challenge phase
No visible change in skin reactions (erythema and / or swelling) were found on the right treated skin of each animal in the control animals and treated animals observed at 24h and 48h observation after the patch was removed and the scores were all 0.
The incidence of skin sensitisation was 0% and the severity index was 0 at 24h and 48h.
4 Body weight
The animals weighed on the receiving day, the day before first dosing day and at the conclusion of the study. The mean body weight of the treatment and control group showed an increasing trend and not affected by the test item.
5 Moribundity and mortality observation
No moribundity or deaths were found during the whole test period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on above results, Enzymatically produced steviol glycosides is not a skin sensitizer to Guinea pigs. The results do not meet the GHS classification criteria for skin sensitisation (Buehler method).
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