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EC number: 224-736-9 | CAS number: 4468-02-4
- 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:
- key study
- Study period:
- February 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- equivalent to OECD 404
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Bis(D-gluconato-O1,O2)zinc
- EC Number:
- 224-736-9
- EC Name:
- Bis(D-gluconato-O1,O2)zinc
- Cas Number:
- 4468-02-4
- Molecular formula:
- C12H22O14Zn
- IUPAC Name:
- bis(D-gluconato-O1,O2)zinc
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Appearance : White cristalline powder:
- Batch number: 1700001575
- Manufacturing date: 10.08.2017
- Expiry date: 09.08.2020
Constituent 1
- Specific details on test material used for the study:
- - Source of test material:
The test compound "zinc glucona te granular" was supplied by the sponsor Akzo Chemie BV, Amersfoort.
- General characteristics: The test substance is a fine, white granular.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harald SChriever, Kan inchen farm, D - 2140 Bremervörde, Neuendamm 88
- Weight at study initiation: 2,4 - 2,6 kg
- Diet: Mümmel Z Kaninchenzuchtkorn produced by Ssniff Spezialfutter GmbH. (Pellets, 1,0 - 1,5 cm large, 0,5 cm diameter, detailled composition in the study report) + Feed additives (vitamines A, D and E. Butylhydroxytoluol).
- Water: ad libitum (quality: aqua fontana as for human consumption)
- Acclimation period: 7 days at least
- Size: 35 cm high, 35 cm wide, 50 cm long
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18°C ± 2°C
- Humidity (%): 50 - 85 %
- Lighting: fluorescent light, 4000 K, 120 Lux
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):
- Caging: single caging in battery of cages
- Cagetype: lattice plate boxes with feacel bassin underneath.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
Amount applied: 0,5 g of the powder was applied to both intact and scarified skin sites on the dorsal area.
VEHICLE
No vehicle used. - Duration of treatment / exposure:
- 4 hours later the test sites were uncovered and the test substance was removed
- Observation period:
- The judgement of the skin alterations was done 30' - 60', 24h, 48h and 72h p.a. after the patch removal
- Number of animals:
- 3
- Details on study design:
- The left side of the back was scarified with a clean clipper blade, so as to penetrate the horny layer of the epidermis, but without causing bleeding. The right side was left intact. The results of both left and right side are presented independently.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- The judgement of the skin alterations was done 30' - 60', 24h, 48h and 72h p.a. after the patch removal. The sample did not induce any skin irritation during the entire observation period of 72 h. The primary irritation index was 0.0.
Any other information on results incl. tables
Animal N° |
30’-60’+24h |
48h |
72h |
||||||||||
erythema |
edema |
erythema |
edema |
erythema |
edema |
||||||||
T |
C |
T |
C |
T |
C |
T |
C |
T |
C |
T |
C |
||
1 |
Scarified |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Intact |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 |
Scarified |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Intact |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 |
Scarified |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Intact |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The sample "zinc gluconate granular" is considered to be not irritating under the conditions described.
- Executive summary:
The relative level of primary skin irritation of the test sample "zinc gluconate granular" was investigated in one group three rabbits. The exposition period of the test substance was 4 hours. Any signs of erythema, eschar and edema formation were recorded during the observation period of 72 hours. The judgement of the skin alterations was done 30' - 60', 24h, 48h and 72h p.a. after the patch removal. The sample did not induce any skin irritation during the entire observation period of 72 h. The primary irritation index was 0.0. All animals showed a normal food consumption and a normal weight gain. The sample "zinc gluconate granular" is considered to be not irritating under the conditions described.
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