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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment

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, Nakamura A
Year:
1996
Bibliographic source:
Biomaterials 17: 2103-2108

Materials and methods

Principles of method if other than guideline:
The sensitization potential of titanium tetrachloride was evaluated in the guinea pig maximization test.
GLP compliance:
not specified
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
Titanium tetrachloride
EC Number:
231-441-9
EC Name:
Titanium tetrachloride
Cas Number:
7550-45-0
Molecular formula:
Cl4Ti
IUPAC Name:
titanium(4+) tetrachloride
Details on test material:
- Name of test material (as cited in study report): TiCl4
- Analytical purity: The test substance was obtained from Wako Pure Chemical Industries, no data on purity

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Japan SLC Inc.
- Weight at study initiation: 350-400 g

ENVIRONMENTAL CONDITIONS
no data

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: saline or ethanol
Concentration / amount:
intradermal injection (induction): 0 and 1%; topical application (induction): 0 and 1%; Challenge: 0, 2 and 5 %
Challengeopen allclose all
Route:
other: epicutaneous
Vehicle:
other: saline or ethanol
Concentration / amount:
intradermal injection (induction): 0 and 1%; topical application (induction): 0 and 1%; Challenge: 0, 2 and 5 %
No. of animals per dose:
controls: 5 each challenge dose
inducted animals: 10 each challenge dose
Positive control substance(s):
not specified

Results and discussion

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:
5
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: 5.0.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
2 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 2 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
5 %
No. with + reactions:
0
Total no. in group:
5
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: 5.0.
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
10
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: 10.0.
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
2 %
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
1/10 animals with grade 1 erythema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 2 %. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: 1/10 animals with grade 1 erythema.
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5 %
No. with + reactions:
5
Total no. in group:
10
Clinical observations:
5/10 animals with grade 1 erythema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5 %. No with. + reactions: 5.0. Total no. in groups: 10.0. Clinical observations: 5/10 animals with grade 1 erythema.

Any other information on results incl. tables

Due to the results of the GPMT, the test substance has to be classified as skin sensitizer at a dose level of 5% but not at 2% and below.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information