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EC number: 233-058-2 | CAS number: 10026-11-6
Toxicological information
Skin sensitisation
Currently viewing:
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- ZrCl4 is dissolved in FCA and ethanol emulsion. As a consequence, ZrCl4 does not decompose into ZrOCl2 and HCl (which is corrosive). So this study does not reproduce the real conditions of exposure to ZrCl4 and the real ZrCl4 behaviour. Therefore, it has been judged not relevant
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- publication
- Title:
- Evaluation of skin sensitization potential of nickel, chromium, titanium and zirconium salts using guinea-pigs and mice
- Author:
- Ikarashi Y, Momma J., Tsuchiya T. and Nakamura A.
- Year:
- 1 996
- Bibliographic source:
- Biomaterials 17 (21) 2103-2106
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- There are only 5 animals by dose and other modification were made (Kakamura et al., 1994).
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Zirconium tetrachloride
- EC Number:
- 233-058-2
- EC Name:
- Zirconium tetrachloride
- Cas Number:
- 10026-11-6
- Molecular formula:
- Cl4Zr
- IUPAC Name:
- zirconium tetrachloride
- Details on test material:
- ZrCl4 was obtained from Wako Pure Chemical Industries, Ltd (Osaka, Japan)
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Guinea pig were purchased from Japan SLC Inc. (Shizuoka, Japan)
Weight at study initiation: 350-400g
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- Guinea-pig maximization test
Induction: Intradermal injection (1% of ZrCl4and saline) and Topical application ( 5% ZrCl4 and petrolatum)
Challenge: Challenge: 20 µl of various concentrations on flank (5% of ZrCl4 and 70% ethanol)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- Guinea-pig maximization test
Induction: Intradermal injection (1% of ZrCl4and saline) and Topical application ( 5% ZrCl4 and petrolatum)
Challenge: Challenge: 20 µl of various concentrations on flank (5% of ZrCl4 and 70% ethanol)
- No. of animals per dose:
- 5
- Details on study design:
- Sensitization
Prelimenary irritation tests were carried out to determine the suitable concentrations for induction and challenge. Test guinea-pigs received a series of 6 intradermal injections of ZrCl4 at 1% in FCA emulsion into the shoulder region to induce sensitization. Seven days later, the animals received a 48h occluded patch containing the chemical at the same site to boost sensitization.
Challenge
The animals were challenged on flank with 20 µl of various concentrations of ZrCl4 on the 14 days following the induction. Skin reaction was determined by visual assessment 48h after challenge. The intensity of the reaction was scored according to the criteria; 0= non visible change, 1=slight or discrete erythema, 2=moderate and confluent erythema, 3=intense erythema and swelling. The sensitization rate and mean skin response were also calculated. Rechallenge was performed on the 7th day after the first challenge. - Challenge controls:
- Control guinea-pigs (No. of animals = 3) were treated with the appropriate vehicle under identical conditions.
- 0% vehicule
- 5 % vehicule - Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- ZrCl4 did not cause any sensitization responses under the condition of this test. Rechallenge was not performed on the 7 days after the first challenge.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 3
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 3.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 3
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 3.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Under the condition of this study, ZrCl4 did not show any sensitization response. Howerver, ZrCl4 is in FCA and ethanol (70%) emulsion and it does not decompose in ZrOCl2 and HCl (which is corrosive). So this study does not reproduce the real conditions of ZrCl4 exposure and the real ZrCl4 behaviour.
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