Registration Dossier
Registration Dossier
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EC number: 258-207-9 | CAS number: 52829-07-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21.11.1983 - 22.12.1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: - A pilot study was routinely performed in the test laboratory, but results are not reported.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Valid test data with guinea pigs are available, no further studies are required.
Test material
- Reference substance name:
- Bis(2,2,6,6-tetramethyl-4-piperidyl) sebacate
- EC Number:
- 258-207-9
- EC Name:
- Bis(2,2,6,6-tetramethyl-4-piperidyl) sebacate
- Cas Number:
- 52829-07-9
- Molecular formula:
- C28H52N2O4
- IUPAC Name:
- bis(2,2,6,6-tetramethylpiperidin-4-yl) sebacate
- Details on test material:
- - Physical state: solid
- Analytical purity: 99.7%
- Storage condition of test material: Room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: in-house bred
- Age at study initiation: ca. 10 weeks
- Weight at study initiation: 332-478 g
- Housing: individually in Macrolon cages (type 3)
- Diet: ad libitum standard guinea pig pellets - NAFAG No. 846, Gossau SG - supplemented with fresh carrots.
- Water: ad libitum)
- Acclimation period: 18 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±2
- Humidity (%): 50±10
- Photoperiod (hrs dark / hrs light): 10/14
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: sesame oil for intradermal and vaseline for epidermal
- Concentration / amount:
- - Concentrations used for induction: 1% in sesame oil for intradermal and 10% in vaseline for epidermal induction
- Concentrations used for challenge: 1% in vaseline
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: sesame oil for intradermal and vaseline for epidermal
- Concentration / amount:
- - Concentrations used for induction: 1% in sesame oil for intradermal and 10% in vaseline for epidermal induction
- Concentrations used for challenge: 1% in vaseline
- No. of animals per dose:
- 10/sex
- Details on study design:
- RANGE FINDING TESTS
The concentrations of the test compound for induction and challenge period were determined on separate animals.
MAIN STUDY
A. INDUCTION EXPOSURE
Two intradermal injections (0.1 ml per injection) were made into the neck of the guinea pigs with a mixture of adjuvant and saline, with the test compound in sesame oil and with the test compound in the adjuvant saline mixture. One week later test material was incorporated in vaseline and applied on a filterpaper patch to the neck of the animals (occlusive administration for 48 hours).
- Control group: treated with adjuvant and the vehicle during the induction period
- Concentrations: 1% for intradermal and 10% for epidermal induction
B. CHALLENGE EXPOSURE
Two weeks after the epidermal induction application the animals were tested on the flank with 1% test material in vaseline and the vehicle alone (24 h occlusive application). Twenty four hours after removing the dressings the challenge reactions were graded according the Draize scoring scale. The application sites were chemically depilated 3 hours before examination (Veet, 5 minutes). A second evaluation is made 48 hours after removing the
dressings. During the challenge period
the group was
- Control group: treated with the vehicle as well as with the test compound to control the maximal subirritant concentration of the test compound in adjuvant treated animals.
- Concentrations: 1% - Positive control substance(s):
- yes
- Remarks:
- p-phenylenediamine
Results and discussion
- Positive control results:
- The sensitivity of the strain is controlled every six month with p-phenylenediamine, but the results are not reported.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1%
- 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: 1%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1%
- 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: 1%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 20.0.
Any other information on results incl. tables
ADDITIONAL RESULTS OF TEST
- Body weight gain: no treatment-related effects
- Clinical signs: none reported
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- No animal showed a sensitization reaction (0/20) and the test article is considered as not sensitizing.
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