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EC number: 946-329-1 | 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
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Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January 15, 2016 - March 10, 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well documented GLP Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Exception to guideline 404, for not testing weight of evidence analysis by the test facility.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction products of sodium glucoheptonate with zinc sulfate and sodium hydroxide
- EC Number:
- 946-329-1
- Molecular formula:
- Not specified (UVCB substance).Molecular formula of the main substance:C14H30O22SZn2
- IUPAC Name:
- Reaction products of sodium glucoheptonate with zinc sulfate and sodium hydroxide
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): DABQUEL COMPLEX ZnP
- Substance type: complex
- Physical state: solid - Odorless pale brown microgranulated
- Composition of test material, percentage of components:
Zinc complexed content: 12.8%
Total Zinc content: 14.0%
- Lot/batch No.: 4149Z0518
- Expiration date of the lot/batch: May 18, 2018
- Storage condition of test material:
Storage Temperature: Room temperature
Storage Container: Keep container tightly closed in a dry, cool and well ventilated place
Storage Location: Test Item Control Office, JRF
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Sainath Agencies, Hyderabad, India
- Age at study initiation: 4.5 to 5.5 months
- Weight at study initiation: Minimum: 2.379, Maximum: 2.467
- Housing: individually in stainless steel wire meshed cages were used.
- Diet (e.g. ad libitum): Teklad certified Global High Fiber Rabbit pellet Feed manufactured by Harlan, USA ad libitum
- Water (e.g. ad libitum): UV sterilised drinking water filtered through Kent Reverse Osmosis water filtration system ad libitum
- Acclimation period: 7 to 9 days
Animal Identification
Each rabbit was uniquely numbered on the ear using a tattoo machine. Appropriate labels were attached to the cages indicating the study number, test item code, sex, dose, type of study, cage number and animal number.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 22 °C
- Humidity (%): 63 to 65%
- Air changes (per hr): minimum 15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 h artificial light and 12 h darkness, light hours being 06:00 - 18:00 h
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg
- Concentration (if solution): 1 % - Duration of treatment / exposure:
- 4 hours
- Observation period:
- The skin reactions of each rabbit were observed at 1, 24, 48 and 72 h post patch removal.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
- % coverage:
- Type of wrap if used: gauze patch that was secured at the margins by non-irritating tape for a period of 4 h
REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the 4 h exposure period, the residual test item was removed with cotton soaked in distilled water.
- Time after start of exposure: 4 hours
SCORING SYSTEM:
Irritation was scored according to OECD 404.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24
- Score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48
- Score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72
- Score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24
- Score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48
- Score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72
- Score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Irritant / corrosive response data:
- There were no signs of systemic adverse effect in any treated rabbits.
Erythema was evident at 1 h in all rabbits which resolved by 24 h post patch removal in all rabbits. The mean dermal irritation scores at 24, 48 and 72 h post-patch removal for individual animals were 0.00, 0.00, 0.00 for erythema and 0.00, 0.00, 0.00 for oedema, respectively.
Any other information on results incl. tables
Mean Dermal Irritation Score
The mean dermal irritation scores at 24, 48 and 72 h post-patch removal for animal Nº 1, 2 and 3 were 0.00, 0.00, 0.00 for erythema and 0.00, 0.00, 0.00 for oedema, respectively (TABLE 2).
Narrative Description of Skin Reactions
Following the 4 h exposure period (day 0), the skin of each rabbit was observed at 1, 24, 48 and 72 h post patch removal.
At 1 h post patch removal, the treated skin site revealed very slight erythema (barely perceptible) in all three rabbits (TABLE 1).
At 24 h post patch TIA, the treated skin site recovered completely and appeared normal in all three rabbits throughout the experimental period (TABLE 1).
The control skin sites of all three rabbits were normal with no erythema and no oedema observed throughout the experimental period (TABLE 1).
Clinical Observations other than Dermal Irritation
No clinical signs were observed in any rabbit throughout the experimental period (TABLE 2).
Interpretation of Results
The mean scores of erythema (0.00) and oedema (0.00) observed at the 24, 48 and 72 h post patch removal observation time-points indicated that the DABQUEL COMPLEX ZnP is a non-irritant under the described experimental conditions.
Acute Dermal Irritation Study of zinc glucoheptonate in Rabbits
TABLE1: Dermal Irritation Scores
Control Site: Untreated
Sex: MaleRabbit N° |
Site of Application |
Observations after Patch Removal |
|||||||
Erythema |
Oedema |
||||||||
Hour |
Hour |
||||||||
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
||
1 |
Left |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
Right |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
Right |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Treated Site: 500 mg zinc glucoheptonate (pulverised and moistened with 0.5 mL distilled water)
Rabbit N° |
Site of Application |
Observations after Patch Removal |
|||||||
Erythema |
Oedema |
||||||||
Hour |
Hour |
||||||||
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
||
1 |
Right |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
Left |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
Left |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Note: Refer section 2.12 for Irritation Scores
Acute Dermal Irritation Study of zinc glucoheptonate in Rabbits
Table 2: Clinical Observations and Body Weight (kg) of Individual Rabbit
Sex: Male
Rabbit N° |
Clinical Observations made on Day |
Body Weights (kg) |
||||
0 |
1 |
2 |
3 |
Before Treatment |
At Termination |
|
1 |
1 |
1 |
1 |
1 |
2.415 |
2.544 |
2 |
1 |
1 |
1 |
1 |
2.467 |
2.553 |
3 |
1 |
1 |
1 |
1 |
2.379 |
2.428 |
Key: 0 = Day of dermal application
Clinical Sign: 1 = Normal
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Conclusions:
- Based on the results of this study, and the Globally Harmonized System of Classification and Labelling of Chemicals (GHS 2015), the registered substance is not classified as a skin irritant
- Executive summary:
In an acute dermal irritation study, three adult male New Zealand White rabbits were dermally exposed to 500 mg of the registered substance (pulverised and moistened with 0.5 mL distilled water), for 4 h (day 0), applied to approximately 6 cm² area of skin. Initially one rabbit was tested with a single patch applied evenly to the intact skin for a period of 4 h. Based on the observations at 24 h post patch removal, two additional rabbits were tested simultaneously to confirm the irritation response. The control skin site of each rabbit was untreated. The treated and the control sites were covered with a gauze patch that was secured at the margins by non-irritating tape for a period of 4 h. At the end of the 4 h exposure period, the residual test item was removed with cotton soaked in distilled water. The skin reactions of each rabbit were observed at 1, 24, 48 and 72 h post patch removal. Irritation was scored according to OECD 404.
There were no signs of systemic adverse effect in any treated rabbits.
Erythema was evident at 1 h in all rabbits which resolved by 24 h post patch removal in all rabbits. The mean dermal irritation scores at 24, 48 and 72 h post-patch removal for individual animals were 0.00, 0.00, 0.00 for erythema and 0.00, 0.00, 0.00 for oedema, respectively. Based on the results of this study, and the Globally Harmonized System of Classification and Labelling of Chemicals (GHS 2015), the registered substance is not classified as a skin irritant
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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