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EC number: 235-101-0 | CAS number: 12068-53-0
- 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
Endpoint summary
Administrative data
Description of key information
Skin irritation (OECD 404): not irritating
Eye irritation (OECD 405): not irritating
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 Jan - 01 Feb 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study (although no information on systemic effects are given in the test report, the study is considered to be reliable without restriction as the acute dermal toxicity study did not show adverse systemic effects)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- no information on systemic effects are given in the test report
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- no information on systemic effects are given in the test report
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- GROUPE INTERMINISTERIEL DES PRODUITS CHIMIQUES
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage de Gérome, Quartier Labaste, Linxe, France
- Age at study initiation: 12 - 13 weeks
- Weight at study initiation: 2.48 - 2.85
- Housing: individual
- Diet: SAFE-112, ad libitum
- Water: tap-water from public distribution system
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- the test item was moistened with distilled water prior to treatment to ensure good contact with the skin
- Controls:
- other: not required, untreated sites of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
Reading time points: 1, 24, 48 and 72 h - Number of animals:
- 1 female (initial test)
2 females (confirmatory test) - Details on study design:
- TEST SITE
- Area of exposure: 6 cm² on the flank
- Type of wrap if used: The patch containing the test substance was secured in position with a strip of surgical adhesive tape.
REMOVAL OF TEST SUBSTANCE
- Washing: Residual test material was removed with distilled water.
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize scoring system - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritant / corrosive response data:
- 1 h after patch removal, a very slight erythema of grade 1 was noted on the treated areas of all animals which were fully reversible after 24 h.
- Other effects:
- No systemic adverse effects are described in the report. Test animals gained approx. 100 g body weight during the study period of 3 days.
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
- Conclusions:
- CLP: not classified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study (no information on systemic effects are given in the test report, no anesthetics or analgesics were used)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 24 April 2002
- Deviations:
- yes
- Remarks:
- no information on clinical signs or pain/distress are given in the test report, no anesthetics or analgesics were used
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- no information on clinical signs or pain/distress are given in the test report, no anesthetics or analgesics were used
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- GROUPE INTERMINISTERIEL DES PRODUITS CHIMIQUES
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage de Gérome, Quartier Labaste, Linxe, France
- Age at study initiation: 13 weeks
- Weight during study period: 2.46 - 3.00 kg
- Housing: individual
- Diet: SAFE-112, ad libitum
- Water: tap-water from public distribution system, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated eye served as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- 1 h in 2 animals; the test substance was not washed out in the 3rd animal
- Observation period (in vivo):
- 72 h
Reading time points: 1, 24, 48 and 72 h - Number of animals or in vitro replicates:
- 1 female (initial test)
2 females (confirmatory test) - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: Remaining test item was rinsed with physiological saline in 2 animals
- Time after start of exposure: 1 h
SCORING SYSTEM: similar to Draize scoring system, supplemented with scoring for discharge and extent of opacity
Discharge:
No discharge - 0
Slight discharge (normal slight secretions in the inner corner to be taken into account) -2
Discharge with moistening of the eyelids and neighbouring hairs - 2
Discharge with moistening of the eyelids and large areas around the eye -3
Cornea: Extent of opacity:
Opaque area present but covering 1/4 or less - 1
Between 1/4 or 1/2 - 2
Between 1/2 and 3/4 - 3
Between 3/4 and the entire surface - 4 - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritant / corrosive response data:
- The test item induced only weak reactions including redness of the conjunctivae in 2/3 animals and chemosis in 1/3 animals which were fully reversible within up to 72 or 48 h, respectively. No adverse effects on the cornea or iris were observed.
- Other effects:
- No information on clinical signs or pain/distress are reported.
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
- Conclusions:
- CLP: not classified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation/corrosion
In the acute dermal toxicity study, erythema were observed in all test animals on the treated skin 24 hours after substance application. Therefore, according to the data requirements given in Annex VIII of 1907/2006/EC, an in vivo dermal irritation study was conducted to evaluate the irritating properties of the test substance.
In detail, a GLP-guideline study according to OECD guideline 404 was performed (Colas, S. 2013a). 3 female New Zealand White Rabbits were exposed to 0.5 g of moistened test material for 4 hours under semi-occlusive dressings. Despite slight erythema of grade 1, which were noted on the treated areas of all animals 1 hour after patch removal, no skin reactions were determined at later time points. Body weight gain of test animals was within the expected range. Thus, the test item Zinc aluminium oxide did not show irritating properties in the conducted study.
Eye irritation
The eye irritation potential of Zinc aluminium oxide was evaluated in a sequential testing strategy including an in vitro eye corrosion/irritation test prior to in vivo testing as outlined in the OECD test guideline 405 for eye corrosion/irritation. In detail, a Hen´s egg test-chorioallantoic membrane (HET-CAM) according to the ICCVAM recommended test method protocol was performed (Andres, 2011a). 0.3 mL of the test item were applied unchanged to the CAM´s of 6 fertilized hen´s eggs for up to 300 sec. Afterwards, the CAM was observed for the development of lysis, heamorrhage and coaggulation.0.9% NaCl, 1% SDS and 0.1 N NaOH (each dissolved in deionised water) were included as control substances. Application of the test item induced haemorrhage of the CAM observed after 61.5 s and lysis after 115.7 sec whereas no signs of coaggulation were observed corresponding to an irritation score of 8.32. In contrast, NaCl treated negative controls did not show any sign of irritation. Both positive controls substances induced severe irritation of the CAM as they induced irritation scores of 20.04 and 11.16 for 0.1 N NaOH and 1% SDS, respectively. According to the evaluation criteria, Zinc aluminium oxide was considered as moderately irritating corresponding to an irritation score within the range of 5 – 8.9. As the HET-CAM in vitro assay can only be used for classification as severe eye irritant (Serious eye damage Category 1), the result of the conducted study was considered as insufficient for classification. Thus, further evaluation of the eye irritation potency of Zinc aluminium oxide was performed in a GLP-guideline study according to OECD guideline 405. A single ocular dose of 0.1 g Zinc aluminium oxide was applied to the eye of 3 female New Zealand White Rabbits (Colas, 2013b). In 2 animals, remaining test item was rinsed with physiological saline 1 h after instillation. The test item induced only weak reactions including redness of the conjunctivae in 2/3 animals and chemosis in 1/3 animals with overall mean scores of 0.3, 0.7 and 0.3, respectively. All reactions were fully reversible within up to 72 or 48 h, respectively. No adverse effects on the cornea or iris were observed.
Based on the available data on skin and eye irritation, Zinc aluminium oxide is not considered as irritant.
Justification for classification or non-classification
Based on the available data, Zinc aluminium oxide does not meet the criteria for classification according to Regulation (EC) 1272/2008.
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