Registration Dossier
Registration Dossier
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EC number: 429-370-5 | CAS number: 220410-74-2
Toxicological information
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1999-01-18 to 1999-03-06
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant Guideline study. Acceptable deviation from OECD Guideline 406 (adopted 1992): skin reactions after induction treatment were not reported.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
- Reference Type:
- other: Amendment Final Report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted July 17, 1992
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- -
- EC Number:
- 429-370-5
- EC Name:
- -
- Cas Number:
- 220410-74-2
- Molecular formula:
- C34H67N3O13
- IUPAC Name:
- tris(1,4-dihydroxy-2,2,6,6-tetramethylpiperidin-1-ium) 2-hydroxypropane-1,2,3-tricarboxylate
- Test material form:
- other: Ivory-peach flakes
- Details on test material:
- - Identification: TKA 45021
- Appearance: Ivory-peach flakes
- Lot/batch No.: pax 2068 / rd 100
- Test Item arrived at Test Facility: 1998-11-25
- Storage: desiccated at room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Hilltop Lab Animals Inc., Scottdale, Pennsylvania, USA
- Age at study initiation: not specified
- Weight at study initiation: males 358 g to 414 g; females 363 g to 406 g
- Housing: individually in suspended stainless steel cages
- Diet: PMI Certified Guinea Pig Chow #5026 (Purina Mills, Inc.) ad libitum
- Water: Municipal tap water treated by reverse osmosis ad libitum
- Acclimation period: minimum of five days
ENVIRONMENTAL CONDITIONS
- Temperature: 17-22°C
- Humidity: 21-56%
- Air changes: 10 to 15 air changes per hour
- Photoperiod: 12-hour light / 12-hour dark cycle
IN-LIFE DATES: From: 1999-01-28 (Dose Range Finding) To: 1999-03-06 (Scoring main study)
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- - Topical range-finding study: 100% and at 25%, 50% and 75% w/v in deionized water
- Intradermal range-finding study: 0.1%, 1.0%, 3.0% and 5.0% w/v in deionized water
- Sensitization study: the test article was utilized at 5.0% w/v in deionized water (intradermal induction) and at 100% (topical induction, challenge and rechallenge).
Challengeopen allclose all
- Route:
- other: Hilltop Chamber, epicutaneous
- Vehicle:
- water
- Concentration / amount:
- - Topical range-finding study: 100% and at 25%, 50% and 75% w/v in deionized water
- Intradermal range-finding study: 0.1%, 1.0%, 3.0% and 5.0% w/v in deionized water
- Sensitization study: the test article was utilized at 5.0% w/v in deionized water (intradermal induction) and at 100% (topical induction, challenge and rechallenge).
- No. of animals per dose:
- Topical and intradermal Range-Finding Study: 2 males and 2 females each
Sensitization study: 10 males and 10 females
Challenge control and re-challenge control: 5 males and 5 females each - Details on study design:
- A. INDUCTION EXPOSURE
- No. of exposures
- intradermal (test animals): three pairs of injections on day 0
a. Injection Pair A: 0.1 mL of FCA emulsion
b. Injection Pair B: 0.1 mL of 5.0% test item in deionized water
c. Injection Pair C: 0.1 mL of 5.0% test item/FCA emulsion
- challenge and rechallenge control animals received the same treatment, except test item
- topical: Following clipping , 0.5 mL of 10% w/w sodium lauryl sulfate in petrolatum was spread over the intradermal injection sites on day 6. On day 7, any residual sodium lauryl sulfate preparation was removed, and test item (100% ) or deionized water was applied to the test item or control groups respectively.
- Exposure period, topical: 48 hours (after dosing, the elastic wrap, tape and patch were removed)
- Test groups: one test group
- Control group: a challenge control group and a rechallenge control group
B. CHALLENGE EXPOSURE
- No. of exposures: once, plus one re-challenge to test group
- Day of challenge: day 20
- Day of re-challenge: day 28
- Exposure period: approximately 24 hours
- Test groups: one test group
- Control group: a challenge control group and a rechallenge control group
- Concentrations: 100% test item
- Evaluation: approximately 24 and 48 hours following chamber removal - Positive control substance(s):
- yes
- Remarks:
- Reliability check: alpha-hexylcinnamaldehyde, performed during the past six months
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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