Registration Dossier
Registration Dossier
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EC number: 227-006-8 | CAS number: 5593-70-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- October 23, 1978 - January 12, 1979
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP study that predates current guideline. There is no positive control and no use of Freund's complete adjuvant.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Two days after the primary irritation test (see chapter 7.3.1 Skin irritation/corrosion.weight_of_evidence.001), induction phase for sensitisation test was started. A series of four intradermal injections of 0.1ml of a 1% test substance solution in acetone/dimethyl phthalate (DMP) 1:9 was given to ten guinea pigs, one each week over three-week period. Following two-week rest period, the test animals were challenged for sensitization by applying 0.05ml of a 50% and 5% suspension of test material in acetone on shaved shoulder skin. At the same time a control group of 10 previously unexposed guinea pigs received similair applications to provide a direct comparison of the challenge reactions.
The skin at the challenge site was evaluated for irritation at 24 and 48 hours after application. Sensitization was defined as a significant score increase at challenge over the response expected from the same amount applied initially or on the concurrent controls. - GLP compliance:
- no
- Type of study:
- not specified
- Justification for non-LLNA method:
- Non-GLP study that predates current guidelines and requirements.
Test material
- Reference substance name:
- Titanium tetrabutanolate
- EC Number:
- 227-006-8
- EC Name:
- Titanium tetrabutanolate
- Cas Number:
- 5593-70-4
- Molecular formula:
- C16H36O4Ti
- IUPAC Name:
- titanium(4+) tetrakis(butan-1-olate)
- Details on test material:
- - Name of test material (as cited in study report): Titanic acid, tetrabutyl ester; Haskell No. 12,678
- Substance type: organometallic
- Physical state: liquid
- Analytical purity: 95%
- Lot/batch No.: 12,678
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: albino
- Sex:
- not specified
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 480g
- Weigh at study conclusion: 726g
CONTROL ANIMALS
- Weight at study initiation: 540g
- Weigh at study conclusion: 799g
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- other: acetone/DMP 1:9
- Concentration / amount:
- 0.1ml of a 1% solution (vol/vol) of test material in acetone/DMP 1:9
- Day(s)/duration:
- Days 0, 7, 14, 21
Challenge
- Route:
- epicutaneous, open
- Vehicle:
- other: acetone/DMP 1:9
- Concentration / amount:
- Two weeks after induction
5% and 50% solution (0.05ml) of test material in acetone
- No. of animals per dose:
- 10 animals in test group
10 animals in control group - Details on study design:
- RANGE FINDING TEST:
A range finding test was conducted with the test material using three guinea pigs. Results showed that 100% concentration of the test material is a moderate skin irritant and 50% suspension in acetone did not irritate the skin.
MAIN STUDY:
A. INDUCTION EXPOSURE
- No. of exposures: 4
- Exposure period: 3 weeks
- Test groups: Test substance in acetone/DMP 1:9
- Control group: no exposure
- Site: sacral intradermal injections
- Frequency of applications: every 7th day
- Duration: 0-21 d
- Concentrations: 1% test substance
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 35
- Exposure period: 24, 48 h
- Test groups: 5% and 50% test substance in acetone
- Control group: 5% and 50% test substance in acetone
- Site: shoulder skin
- Concentrations: two different
- Evaluation (hr after challenge): 24, 48 - Challenge controls:
- A control group of 10 previously unexposed guinea pigs received similair applications than the test group at the time of challenge to provide a direct comparison of the challenge reactions.
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Reading:
- 2nd reading
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% suspension in acetone
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Clinical observations:
- 1++, 6+, 3 neg
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50% suspension in acetone. No with. + reactions: 7.0. Total no. in groups: 10.0. Clinical observations: 1++, 6+, 3 neg.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50% suspension in acetone
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- 8+, 2 neg
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50% suspension in acetone. No with. + reactions: 8.0. Total no. in groups: 10.0. Clinical observations: 8+, 2 neg.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50% suspension in acetone
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Clinical observations:
- 1++, 6+, 3neg
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50% suspension in acetone. No with. + reactions: 7.0. Total no. in groups: 10.0. Clinical observations: 1++, 6+, 3neg.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50% suspension in acetone
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- 8+, 2neg
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50% suspension in acetone. No with. + reactions: 8.0. Total no. in groups: 10.0. Clinical observations: 8+, 2neg.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5% suspension in acetone
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- 2+, 8neg
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5% suspension in acetone. No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: 2+, 8neg.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5% suspension in acetone
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- 2+, 8neg
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 5% suspension in acetone. No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: 2+, 8neg.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5% suspension in acetone
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- 10 neg
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5% suspension in acetone. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: 10 neg.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5% suspension in acetone
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- 1+, 9 neg
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 5% suspension in acetone. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: 1+, 9 neg.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- The potential sensitisation properties of titanium tetrabutanolate were tested using primary sensitization test on guinea pigs. Based on the study results test substance is considered as not skin sensitizer. No guideline was followed in this study.
- Executive summary:
The test substance was administrated 1% solution (vol/vol) in acetone/DMP 1:9 in a series of four sacral intradermal injections (10 animals). At the time of challenge 0.05ml 5% and 50% test substance (vol/vol) in acetone was applied and lightly rubbed to the shaved intact shoulder skin. A control group of 10 previously unexposed guinea pigs received similair applications at the same time to provide a direct comparison of the challenge reactions. At challenge no sensitization response was observed.
This study was regarded not reliable since the study report contains insufficient details on study methods and results.
This study does not satisfy the guideline requirements for the sensitization study, but the result is used as a weight of evidence in hazard assessment.
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