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EC number: 260-599-1 | CAS number: 57158-29-9
- 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
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- sub-chronic toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted before internationally agreed test guidelines were applicable. Methods, experimental details and results are reported in detail, and the study design is comparable to modern guidelines. Thus, the study is considered as relible with (minor) restrictions and suitable to derive conclusions for the hazard assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- A 91-day percutaneous toxicity study in rabbits was performed to evaluate the dermal and systemic toxicity of the test material. The test material was applied undiluted, to the shaven backs of 3 male and 3 female New Zealand White rabbits. Daily applications of 2 mL/kg bw/day of the test material (ca. 950 mg /kg/day based on the active ingredient "ZAG") were made 5 days per week for 13 weeks. A control group had an equivalent volume (2 mL/kg) of distilled water applied under the ssame regimen as the test group. Pharmacotoxic signs, mortality, skin reactions, body weight haematological values, organ weights, gross pathology and histopathology were examined.
- GLP compliance:
- no
- Remarks:
- at the time of conduct, GLP was not compulsory.
- Limit test:
- no
Test material
- Reference substance name:
- Zirconium aluminum chlorhydrate/glycine complex Active Premix.
- IUPAC Name:
- Zirconium aluminum chlorhydrate/glycine complex Active Premix.
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): UDL-1641 (Zirconium aluiminium chlorhydrate/glycine complex Active Premix)
- Physical state: clear liquid
- Analytical purity: 100% ZAG Active Premix
- Composition of test material, percentage of components: 47.48% ZAG and 52.52% distilled water.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2265 - 2697 grams
- Housing: the rabbits were individually housed in wire metabolism cages in an environmentally controlled room.
- Acclimation period: two weeks prior to initiation
ENVIRONMENTAL CONDITIONS
- Temperature: ca. 24°C
- Humidity: 50%
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- open
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- TEST SITE
- Area of exposure: the backs of the rabbits were carefully shaved (as needed) prior to applying the test material and distilled water. Approximately 30% of the back was shaven. The skin was abraded twice weekly for two weeks, but abrading was then discontinued for the duration. Abrading of the skin was accomplished using the head of an electric hair-clipper.
The test material was applied with a syringe to the back and spread over the shaved area with a glass rod.
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.0 mL/kg bw/ day
- Constant volume or concentration used: yes, constant volume - Analytical verification of doses or concentrations:
- no
- Details on analytical verification of doses or concentrations:
- none
- Duration of treatment / exposure:
- 91 days
- Frequency of treatment:
- daily for five days per week
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
2 mL/kg bw/day
Basis:
nominal per unit body weight
- Remarks:
- Doses / Concentrations:
ca. 170 mg Al/kg bw/day
Basis:
other: based on element Al
- Remarks:
- Doses / Concentrations:
ca. 100 mg Zr/kg bw/day
Basis:
other: based on element Zr
- No. of animals per sex per dose:
- 3 males / 3 females
- Control animals:
- yes
- Details on study design:
- not applicable
- Positive control:
- none
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
- Cage side observations checked: animals were observed for mortality, pharmacotoxic signs, and skin reactions.
DETAILED CLINICAL OBSERVATIONS: No
DERMAL IRRITATION: Yes (scored according to the scale given in the field "Any other information on materials and methods incl. tables" below)
- Time schedule for examinations: daily
BODY WEIGHT: Yes
- Time schedule for examinations: once weekly
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: prior to initiation and again at termination, blood was taken from ear vein and subjected to haematological determination
- How many animals: all
- Parameters examined: haemoglobin, haematocrit, erythrocyte count, total leucocyte count, differential leucocyte count, mean corpuscular volume, mean corpuscular haemoglobin, and mean corpuscular haemoglobin concentration.
CLINICAL CHEMISTRY: No
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
At the completion of the compound application period, all rabbits were sacrificed with an overdose of sodium pentobarbital administered intravenously in a marginal ear vein. All rabbits were necropsied. At necropsy, contents of the thorax and abdomen were examined in situ and specimens of the following tissues and organs were removed and fixed in buffered neutral 10% formalin: Skin (treated and untreated), brain, pituitary, salivary gland, tongue, trachea, oesophagus, thyroid, parathyroid aorta, bronchial nodes, thymus, heart, lungs, sciatic nerve, spinal cord, ureters, urethra near bladder, bone marrow, liver, spleen, pancreas, stomach, duodenum, jejunum, colon, adrenals, kidney, mesenteric lymph nodes, bladder, prostate, uterus, vaginal wall, ovary/testis, psoas muscle, seminal vesicles, and other tissues with gross lesions.
Hematoxylin and eosin stained paraffin sections of the above tissues from each rabbit were prepared and examined microscopically. - Other examinations:
- Organ weights:
The following organs were weighed: brain, liver, spleen, adrenals, kidney, and ovary/testis.
At necropsy, weigh the liver and kidneys from all animals for determination of organ/body weight ratios.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Dermal irritation:
- effects observed, treatment-related
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY
No changes in appearance or behaviour were observed nor were there other signs of pharmatoxic effect. Only occasional indications of nasal discharge and/or lacrimation were observed in all groups.
BODY WEIGHT AND WEIGHT GAIN
No adverse effect on body weight gain attribute to compound administration was noted.
DERMAL IRRITATION
The results obtained in evaluating the skin reactions indicated average scores of 0.5 or less for rabbits for erythema only.
HAEMATOLOGY
While minor variations occurred, there were no consistent differences between the control group and the test group.
ORGAN WEIGHTS
No compound related variations in organ weights were observed in any of the rabbits in the treated group.
GROSS PATHOLOGY
Other than the skin changes, no compound related gross lesions were observed in any of the rabbits in the treated group. Gross lesions observed were those which commonly occur spontaneously in untreated rabbits in this laboratory.
HISTOPATHOLOGY: NON-NEOPLASTIC
Compound related microscopic lesions were seen in the skin at the application site in all rabbits in the treated group. In the test group, very slight to slight inflammatory cell infiltrate in dermis was common in all rabbits and very slight hyperkeratosis and acanthosis occurred in 2 rabbits. Microscopic lesions in treated rabbits other than those described above were generally those which commonly occur in untreated rabbits in the laboratory that carrying out the study and were not considered significant.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 2 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: The test material is called "ZAG Premix", which is a 47.5% solution of aluminium zirconium chloride hydroxide glycine in water. The dose was 2 mL of the undiluted test item per kg bodyweight per day.
- Dose descriptor:
- NOAEL
- Effect level:
- 170 mg/kg bw/day
- Based on:
- element
- Remarks:
- Al
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day
- Based on:
- element
- Remarks:
- Zr
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Very slight to slight erythema was observed in rabbits treated with the test material. The distilled water control gave no evidence of skin irritation. No body weight changes, nor gross pharmacotoxic signs, attributable to application of the test material, were observed.
Except for the skin changes noted above, no gross lesions or variations in organ weights were observed in any of the rabbits in the treated group. Compound related microscopic lesions in the skin at the application site, consisting of dermal inflammatory cell infiltrate and hyperkeratosis and acanthosis, were observed in rabbits in the treated group.
For systemic effects following dermal application, no adverse effects were observed at the only tested dose (limit test), thus: NOAEL of 2000 mg/kg bw/day, based on test item (47.5% solution of "impalpable ZAG". This corresponds to NOAEL of ca. 170 and ca. 100 mg/kg/day based on Al and Zr respectively.
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