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EC number: 619-635-5 | CAS number: 12567-73-6
- 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
- Study period:
- 22th November 2005-17th February 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to OECD guideline with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Tetrakis(isobutyrato)zirconium
- EC Number:
- 619-635-5
- Cas Number:
- 12567-73-6
- Molecular formula:
- Hill formula: C16H28O8Zr CAS formula: C16H28O8Zr
- IUPAC Name:
- Tetrakis(isobutyrato)zirconium
- Reference substance name:
- Zirconium, tetrakis(isobutyrato)- (8CI)
- IUPAC Name:
- Zirconium, tetrakis(isobutyrato)- (8CI)
- Details on test material:
- - Name of test material (as cited in study report): Zirkonium-tetrakis(isobutyrato)
- Physical state: solid
- Analytical purity: 97.4 % (complexometric titration)
- Impurities (identity and concentrations): By-products:
toluene: ca. 2.1 %.
iso-butyric acid: ca. 0.5 %.
- Lot/batch No.: 02/05 (HK1005)
- Expiration date of the lot/batch: September 2006
- Storage condition of test material: Ambient temperature. Tightly closed. Storage under a nitrogen atmosphere, as the substance reacts with water.
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann, Gartenstrasse 27, D-33178 Borchen, Germany.
- Age at study initiation: Approximatly 5 - 7 weeks
- Weight at study initiation: 331 g to 400 g
- Housing: Group caging in plastic containers (46 cm x 105 cm x 36 cm), partly shaded, 6 (control group) or 11 (test substance group) animals per container
- Diet (e.g. ad libitum): Altromin Maintenance Diet No. 3122, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: Step 1: 12 days, Step 2: 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Step 1: Average of 22.0 °C, Step 2: Average of 21.4 °C
- Humidity (%): Step 1: Average of 62.2 %, Step 2: Average of 45.1 %
- Air changes (per hr): Approximatly 12/h.
- Photoperiod (hrs dark / hrs light): Only artificial light from 6.00 a.m. to 6.00 p.m.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: acetone
- Concentration / amount:
- Step 1 and step 2:
Group C: Negative control:
Induction exposure:
- i.d. exposure: acetone
- epicutaneous exposure: acetone
Challenge exposure:
- left flank: TS, 25 % (w/v) in acetone
- right flank: acetone
Group H: Test substance
Induction exposure:
- i.d. exposure: TS, 0.5 % (w/v) in acetone
- epicutaneous exposure: TS, 25 % (w/v) in acetone
Challenge exposure:
- left flank: TS, 25 % (w/v) in acetone
- right flank: acetone
TS = test substance
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: acetone
- Concentration / amount:
- Step 1 and step 2:
Group C: Negative control:
Induction exposure:
- i.d. exposure: acetone
- epicutaneous exposure: acetone
Challenge exposure:
- left flank: TS, 25 % (w/v) in acetone
- right flank: acetone
Group H: Test substance
Induction exposure:
- i.d. exposure: TS, 0.5 % (w/v) in acetone
- epicutaneous exposure: TS, 25 % (w/v) in acetone
Challenge exposure:
- left flank: TS, 25 % (w/v) in acetone
- right flank: acetone
TS = test substance
- No. of animals per dose:
- In both steps: 10 animals for the test substance group and 5 animals for the control group.
One additional animal per group was kept and administered under the same conditions as the other animals of the respective group. Findings on the spare animals were only incorporated into this report if other animals of the test substance group or of the control group would have died spontaneously. Otherwise, the skin reactions of these animals were not used for the interpretation of the results. - Details on study design:
- RANGE FINDING TESTS: In both steps the test substance concentrations were derived from the results of a preliminary test: 0.5 % (w/v) in acetone for the intradermal induction 25 % (w/v) in acetone for the epicutaneous induction and 25 % (w/v) in acetone for the challenge exposure. 25% (w/v) in acetone was the highest technically feasible test substance concentration.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:
- Exposure period:
- Test groups: yes
- Control group: yes
- Site: interscapular region (intradermal induction exposure)
- Frequency of applications:
- Duration: 48 hours (epidutaneous induction exposure)
- Concentrations: TS, 0.5 % (w/v) in acetone
B. CHALLENGE EXPOSURE
- No. of exposures:
- Day(s) of challenge:
- Exposure period: 24 hours
- Test groups: yes
- Control group: yes
- Site: left flanks
- Concentrations: TS, 25 % (w/v) in acetone
- Evaluation (hr after challenge): The application sites were examined 24 and 48 hours after the end of the epicutaneous challenge exposures (blind reading of test and control animals)
OTHER: - Challenge controls:
- 7/10 animals (70 %) represented the net rate of animals sensitised by "HEXYL CINNAMIC ALDEHYDE".
The results prove the sensitivity of the strain of animals used and the reliability of the experimental technique. - Positive control substance(s):
- yes
- Remarks:
- HEXYL CINNAMIC ALDEHYDE
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: Skin reactions 24 hours after the intradermal and 24 hours after the end of the epicutaneous induction exposures and 24 and 48 hours after the end of the epicutaneous challenge exposure
- Group:
- negative control
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Score 3: severe erythema and/or oedema
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: Skin reactions 24 hours after the intradermal and 24 hours after the end of the epicutaneous induction exposures and 24 and 48 hours after the end of the epicutaneous challenge exposure. Group: negative control. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: Score 3: severe erythema and/or oedema.
- Reading:
- other: Skin reactions 24 hours after the intradermal and 24 hours after the end of the epicutaneous induction exposures and 24 and 48 hours after the end of the epicutaneous challenge exposure.
- Group:
- test chemical
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- Score 3: severe erythema and/or oedema
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: Skin reactions 24 hours after the intradermal and 24 hours after the end of the epicutaneous induction exposures and 24 and 48 hours after the end of the epicutaneous challenge exposure.. Group: test group. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: Score 3: severe erythema and/or oedema.
- Reading:
- other: challenge
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Score 0: no reactions
- Remarks on result:
- other: Reading: other: challenge. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Score 0: no reactions.
- Reading:
- other: challenge
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Score 0: no reactions
- Remarks on result:
- other: Reading: other: challenge. Group: test group. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: Score 0: no reactions.
Any other information on results incl. tables
All animals survived till the end of the study.
No statistically significant differences in the mean body weights between the animals of the test substance groups and those of the control group on Days 0 (step 1 and step 2) and 24 (step 1) were noted.
No abnormal behaviour or clinical signs were detected during the experiment in the animals.
Skin reactions after the epicutaneous induction exposure were marked.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- No animal was regarded as sensitised by the test substance.
- Executive summary:
Skin sensitisation: key study in guinea pigs, according to EC-directive 96/54, B.6., "Skin Sensitization" and the OECD-guideline 406, "Skin Sensitisation".
The "maximisation test" was performed to reveal a possible sensitising potential of Zirkonium-tetrakis(isobutyrato). The study was performed in two consecutive steps. In both steps a test substance group with 10 female guinea pigs and a negative control group with 5 female guinea pigs was used.
There were two induction exposures (intradermal and epicutaneous) and one challenge exposure. In both steps the test substance concentrations were derived from the results of a preliminary test: 0.5 % (w/v) in acetone for the intradermal induction 25 % (w/v) in acetone for the epicutaneous induction and 25 % (w/v) in acetone for the challenge exposure. 25% (w/v) in acetone was the highest technically feasible test substance concentration. Application of Freund's complete adjuvant was included in the intradermal exposure of both groups to enhance a possible sensitisation. For the epicutaneous exposures occlusive dressings were used.
Results showed that all animals survived till the end of the study. No relevant systemic toxic signs were observed. Intradermal injections of Freund's adjuvant caused severe local reactions in all animals, a known effect of the adjuvant. No other adverse effects were noted. The control sites of all animals of both groups were unaffected at each reading time. Neither animals of the test substance group in step 1 had positive skin reactions nor animals of the test substance group in step 2 had positive skin reactions at the test substance treated sites 24 hours and/or 48 hours after the end of the exposure. No adverse skin reactions were observed in the control animals. Therefore no animal of the test substance group was regarded as sensitised.
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