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EC number: 215-180-8 | CAS number: 1310-53-8
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- 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 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The metals industry has historical data to indicate that metals can induce false positives/negatives in LLNA studies; this is confirmed from experiences in test labs.
Test material
- Reference substance name:
- Germanium dioxide
- EC Number:
- 215-180-8
- EC Name:
- Germanium dioxide
- Cas Number:
- 1310-53-8
- Molecular formula:
- GeO2
- IUPAC Name:
- Germanium dioxide
- Test material form:
- solid: particulate/powder
- Details on test material:
- Batch number: 968
Description: White Solid (powder)
Purity: 99.9%
Storage conditions: Controlled room temperature (15-25°C, below 70% RH%)
Safety precautions: Routine safety precautions (lab coat, gloves, safety glasses and face mask) for unknown materials were applied to assure personnel health and safety."
Grain size: d50: 14.3 µm
Bulk density: 0.9-1.2 kg/l
Moisture: ≤ 0.5%
Chlorine (Cl): 118 ppm
Aluminium (Al): <0.2 ppm
Calcium (Ca) <0.2 ppm
Iron (Fe) <0.2 ppm
Silicon (Si) <1ppm
solubility >4.5g/l
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: LAB-ÁLL Bt. Budapest, 1174 Hunyadi u. 7
- Age at study initiation: Young adult, ~ 7 weeks old
- Weight at study initiation: 346 – 400 g
- Housing: Animals were housed in macrolon cages size IV, with 5 animals/cage to allow socialization
- Diet ad libitum: Cunigra Diet for Rabbits (produced by Bonafarm-Bábolna Takarmány Ltd., Hungary)
- Water ad libitum: Animals received tap water from municipal supply as for human consumption, containing 50 mg/100 ml ascorbic acid,
- Acclimation period: 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.6 - 23.4 °C
- Humidity (%): 28 - 80%
- Air changes (per hr): 15-20 air exchange/hour
- Photoperiod (hrs dark / hrs light): 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: Methylcellulose
- Concentration / amount:
- 5 % (w/v) GeO2 in 1% methylcellulose
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: methylcellulose
- Concentration / amount:
- 75 % (w/v) GeO2 in 1% methylcellulose
- Day(s)/duration:
- 48h
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Methylcellulose
- Concentration / amount:
- 75 % (w/v) GeO2 in 1% methylcellulose
- Day(s)/duration:
- 24h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- test groups: 10
control group: 5 - Details on study design:
- RANGE FINDING TESTS:
A series of test item concentrations was tested to identify the primary irritation following intradermal injection and dermal application: 1, 2.5 and 5% (w/v) concentrations were used for intradermal injection and 10, 25, 50, 75% (w/v) for dermal application. Local effects were examined and scored 1, 24, 48 and 72 hours after the treatment or after patch removal. Skin effects were scored for erythema and oedema, any other observations of changes to the skin was recorded.
*)For the intradermal application, 0.1 mL per concentration was injected intradermally into the hair free skin of the animals. Two concentrations were injected on the right side and another two concentrations on the left side of the animals. The highest concentration (5%) was also tested in a 1:1 mixture (v/v) of Freund's Complete Adjuvant and physiological saline solution. Each concentration was injected in duplicate. Two animals were used per concentration.
First, the intradermal application was tried with the test item in the form as it was supplied by the Sponsor, but the treatments could not be performed at concentrations above 1% (w/v). (The test item blocked the needle of the syringe.) Because of this, the test item was ground with a ball mill, and the intradermal preliminary study was repeated.
The highest concentration (5%) caused no more than mild-to-moderate erythema (score 0 or 1) during the observation period, therefore this concentration could be used in the main study.
*) For the dermal application, the volume of the concentrations was 0.5 mL. A closed patch exposure was performed by means of an occlusive bandage using similar treatment procedures as for the main study. The time of exposure for the dermal application was 48 hours. One concentration was used on the right side and another concentration on the left side of animals. Two animals per concentrations were used. It was found that all the dermal treatments at the tested concentrations produced no reaction on the skin of guinea pigs, except in one animal at 1 hour after the patch removal slight erythema was seen. This observation was considered not to be test item related therefore it was not taken into account for determining the doses of the main study. The concentration used for the challenge exposure should be the highest non-irritant dose; therefore 75% test item formulated in 1% methyl cellulose was decided to be used for the challenge treatment.
MAIN STUDY (cfr any other information on materials and methods)
A. INDUCTION EXPOSURE
a) intra-dermal induction exposure:
b) dermal induction exposure:
B. CHALLENGE EXPOSURE - Positive control substance(s):
- not required
- Remarks:
- The sensitivity and reliability of the experimental procedure is assessed twice a year by use of items which are known to have moderate skin sensitisation properties (eg 2-mercaptobenzothiazole. 2-mercaptobenzothiazole was classified as skin sensitizer.
Results and discussion
- Positive control results:
- The sensitivity and reliability of the experimental procedure is assessed twice a year by use of items which are known to have moderate skin sensitisation properties such as 2-Mercaptobenzothiazole.
Challenge with reference item 2-Mercaptobenzothiazole resulted in a positive response in test animals previously sensitised. The net response values at the 24 and 48 hours observations represented an incidence rate of 90% and 80% and net score values of 0.90 and 0.80 respectively. In the control animals no visible changes were found either at the 24 or 48 hours examinations following challenge with the reference item.
The dermal scores represented discrete erythema (score 1) developed on the skin of sensitised guinea pigs.
On the basis of the results of the reliability check study, the reference item 2-Mercaptobenzothiazole was classified as a skin sensitizer. This demonstrated that the experimental procedure and the test system were appropriate.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75% (w/v) GeO2 in 1% methylcellulose
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No signs of systemic or local toxicity were observed in any animal
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 75% (w/v) GeO2 in 1% methylcellulose
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No signs of systemic or local toxicity were observed in any animal
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75% (w/v) GeO2 in 1% methylcellulose
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No signs of systemic or local toxicity were observed in any animal
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 75% (w/v) GeO2 in 1% methylcellulose
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No signs of systemic or local toxicity were observed in any animal
- Remarks on result:
- no indication of skin sensitisation
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Remarks:
- Not required: The sensitivity and reliability of the experimental procedure is assessed twice a year by use of items which are known to have moderate skin sensitisation properties (eg 2-mercaptobenzothiazole. 2-mercaptobenzothiazole was classified as skin sensitizer.
Any other information on results incl. tables
Ten test animals were subjected to sensitisation procedures in a two-stage process, i.e. an intradermal treatment and a topical application. The test item was used at a concentration of 5% (w/v) for intradermal injections and at a concentration of 75% (w/v) for dermal sensitisation treatment. Two weeks after the last induction exposure, a challenge dose at a concentration of 75% (w/v) was administered on the left side of animals. The right side of animals was treated with 50% dilution of the maximum dermal challenge dose as a safeguard dose (37.5% (w/v)). Challenge was performed by dermal application of the test item.
Five control guinea pigs were simultaneously exposed to vehicle only during the sensitisation phase I (intradermal treatment) and during the sensitisation phase II (dermal treatment). Control animals were treated with the test item at concentrations of 75% (w/v) and 37.5% (w/v) only during the challenge.
1% methyl cellulose was used as a vehicle for each formulation during the study.
Skin Effects after the Challenge Exposure
Test group
After the challenge with the test item at a concentration of 100 % (w/v) in 1 % methylcellulose, no positive response was observed in the treated animals. The mean of the scores was 0.00 according to the 24 and 48-hours results. The right shaved flank area of all animals was treated with a test item concentration of 50 (w/v) % in 1 % methylcelluloseas a safeguard and no reaction was noted.
Control group
After the challenge with the test item at a concentration of 75 % (w/v) in1 % methylcellulose no visible changes were found at the 24 and 48 hours examinations. The right shaved flank area of control animals was treated with a test item concentration of 37.5 (w/v) % in 1 % methylcellulose as a safeguardand no reaction was noted.
Body weight
There were no notable differences between the test animal group and the control group.
Clinical Observations and mortality
No signs of systemic or local toxicity were observed in any animal.. No mortality was observed during the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
Under the conditions of the present assay the test item GERMANIUM DIOXIDE was shown to have no sensitisation potential and classified as a non-sensitizer, according to current EU-regulations.
- Executive summary:
A skin sensitisation study was performed in the guinea pig according to the Magnusson and Kligman method, using a maximisation method with Freund's Complete Adjuvant to evaluate the sensitisation potential of test item. The study was performed according to OECD Guideline No. 406 (adopted in 1992) and in compliance with GLP guidelines.
Based on the results of a preliminary test, ten test animals were subjected to sensitisation procedures in a two-stage process, named induction phase: i.e. an intradermal treatment and a 48-hour topical application (dermal treatment under an occlusive dressing). The test item was used at a concentration of 5% (w/v) for intradermal injections and at a concentration of 75% (w/v) for topical sensitisation treatment. Five control guinea pigs were simultaneously exposed to vehicle only during the sensitisation phase.
Two weeks after the last induction exposure, a challenge dose at a concentration of 75% (w/v) was administered on the left side of all animals. The right side of the animals was treated with 50% dilution of the maximum dermal challenge dose as a safeguard dose (37.5% (w/v)). Challenge was performed by dermal application of the test item. Skin reactions were measured 24 and 48 hours after patch removal.
Results
No signs of systemic or local toxicity were observed in any animal.
Incidence rate:
No signs of contact sensitisation were detected in guinea pigs previously exposed to the test item during the experiment.
Intensity of sensitisation response:
In the control and treated animals the mean of the scores was 0.00 according to the 24 and 48-hour results.
In conclusion, under the conditions of the present assay the test item GERMANIUM DIOXIDE was shown to have no sensitisation potential and classified as a non-sensitizer, according to current EU-regulations.
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