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Skin sensitisation

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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:
reference to same study
Reason / purpose:
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:
1996
Bibliographic source:
Biomaterials 17 (21) 2103-2106

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
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
Name:
Unnamed
Type:
Constituent
Details on test material:
ZrCl4 was obtained from Wako Pure Chemical Industries, Ltd (Osaka, Japan)

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 group
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 group
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.