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Registration Dossier
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EC number: 240-015-1 | CAS number: 15879-01-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- Guinea pig maximisation test (GPMT) (OECD 406)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29 Sept 1989 - 29 Mar 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 12.5.1981
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The GPMT study was conduct in 1990 prior recommendation to use LLNA
Test material
- Reference substance name:
- Titanium 2,2',2''-nitrilotrisethanolate
- EC Number:
- 240-015-1
- EC Name:
- Titanium 2,2',2''-nitrilotrisethanolate
- Cas Number:
- 15879-01-3
- Molecular formula:
- C6H15NO3.xTi
- IUPAC Name:
- titanium 2,2',2''-nitrilotrisethanolate
- Test material form:
- liquid
- Details on test material:
- Test Item Name Tyzor TE
IUPAC Name titanium 2,2',2''-nitrilotrisethanolate
CAS No. 15879-01-3
EC No. 240-015-1
Appearance Light yellow liquid
manufactured by Dorf Ketal Speciality Catalyst Pvt Limited
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Bor: DHPW
- Sex:
- not specified
- Details on test animals and environmental conditions:
- - Weight at study initiation: 431 g (test group); 454 g (controls)
- Housing: 1-5 animals in Macrolon cages type IV
- Diet (e.g. ad libitum): ad libitum, guinea pig complete diet G4
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 5-8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1 deg C
- Humidity (%): 60 +/- 5 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12TEST ANIMALS
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- corn oil
- Concentration / amount:
- 0.1ml 0.5 % test substance
- Day(s)/duration:
- 7 days
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100 %
- Day(s)/duration:
- 2
- No. of animals per dose:
- 20 (test item)
10 (control) - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 intradermal and topical
- Test groups: 1
- Control group: 1
- Site: Three pairs of intradermal injections of 0.1 ml volume are given in the shoulder region which is cleared of hair so that one of each pair lies on each side of the midline.
- Frequency of applications: once
- Duration: 7 days
- Concentrations:
Day 0: Intradermal application:
Test animals (20): 0.1 ml mixture (1:1) FCA and H2O ; 0.1 ml 0.5% test substance in corn oil ; 0.1 ml 0.5% test substance in FCA:H2O (1:1).
Control animals (10): 0.1 ml mixture (1:1) FCA and H2O ; 0.1 ml corn oil ; 0.1 ml FCA:H2O (1:1).
Day 7: Topical application:
Test group: A filter paper (2 x 4 cm) was fully-loaded with test substance applied to the test area and held in contact by an occlusive dressing for 48 hours.
Control animals: Corn oil was applied in the similair manner
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 7 & 21
- Exposure period: 2 days
- Test groups: 1
- Control group: 1
- Concentrations: All animals: A patch loaded with the test substance is applied to one flank of the animals and a patch with the vehicle only was applied to the other flank. The patches are held in contact by an occlusive dressing for 48 hours (1st challenge) and 24 hours (2nd challenge)
- Evaluation (hr after challenge): 24h and 48h
OTHER: Approximately twenty-four hours before the topical induction application, the test area was treated with 10% SDS in vaseline, in order to create a local irritation.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30 % test substance
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30 % test substance
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Group:
- positive control
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Conclusions:
- Titanium 2,2´,2´´-nitrilotrisethanolate demonstrated no sensitizing effect on the skin of female guinea pigs in the Magnusson-Kligman maximization test.
- Executive summary:
Three pairs of intradermal injections of 0.1 ml were given in the shoulder region of animals (20 animals).
Injection 1: a 1:1 mixture (v/v) FCA/water
Injection 2: the 0.5% test substance in corn oil
Injection 3: the 0.5 % test substance in a 1:1 mixture (v/v) FCA/water
Control animals were treated with similar manner
Injection 1: a 1:1 mixture (v/v) FCA/water
Injection 2: corn oil
Injection 3: a 1:1 mixture (v/v) FCA/corn oil
At day 6 before the topical induction application, as the substance was not a skin irritant, the test area, after shaving was handled with 10% SDS in vaseline in order to create a local irritation. At day 7 a filter paper (2 x 4 cm) was fully-loaded with 100% test substance and applied to the test area and held in contact by an occlusive dressing for 48 hours. Control animals were exposed to corn oil in a similar manner.
At day 21 second challenge was conducted. A patch loaded with the 30% test substance was applied to one flank of the animals. The patches were held in contact by an occlusive dressing for 24 hours. At 24 hours and 48 hours skin reactions were observed and recorded according to the Magnusson and Kligman grading scale.
At challenge no skin reactions were observed in any animals tested.
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