Registration Dossier
Registration Dossier
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EC number: 231-441-9 | CAS number: 7550-45-0
Skin sensitisation
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:
- 1 996
- 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
- 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 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
Constituent 1
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
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