Registration Dossier
Registration Dossier
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EC number: 262-679-1 | CAS number: 61260-55-7
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:
- 04 Jan - 19 Feb 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted February, 1987
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
Test material
- Reference substance name:
- N,N'-bis(2,2,6,6-tetramethylpiperidin-4-yl)hexane-1,6-diamine
- EC Number:
- 262-679-1
- EC Name:
- N,N'-bis(2,2,6,6-tetramethylpiperidin-4-yl)hexane-1,6-diamine
- Cas Number:
- 61260-55-7
- Molecular formula:
- C24H50N4
- IUPAC Name:
- N1,N6-bis(2,2,6,6-tetramethylpiperidin-4-yl)hexane-1,6-diamine
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Fa. Winkelmann, 4799 Borchen
- Age at study initiation: adult animals
- Weight at study initiation: 358 - 362 g
- Diet (ad libitum): Ssniff G 4 - Alleindiät for guinea pigs, Firma Ssniff, Spezialfutter GmbH, 4770 Soest
- Water (ad libitum): tap water, Fa. Gelsenwasser, Wasserwerk, 4358 Haltern
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 1.0% (Induction and Challenge), 10.0% (Preliminary and Induction))
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 1.0% (Induction and Challenge), 10.0% (Preliminary and Induction))
- No. of animals per dose:
- Preliminary study: 4
Main study: 20
Control group for main study: 10 - Details on study design:
- RANGE FINDING TESTS:
In the preliminary test, a concentration of 10.0% of the test substance in vaseline had no primary irritant effect. Therefore, for the induction phases I, II and III, and for the challenge treatment, the 10.0% test substance concentration in vaseline was initially established. Since, after the first induction inthe main study, skin irritation occurred in eight of 20 test animals, for the following inductions and for the challenge treatment, the test substance concentration was decreased to 1.0%.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Control group: 10 animals (Vehicle treated)
- Site: left flank
- Test groups: 20 animals
- Frequency of applications: single exposure (Induction 1 (day 0) and Inductions 2 (day 7) and 3 (day 14))
- Duration: 0-14 d
- Concentrations: Induction 1: 10.0% Induction 2 and 3: 1.0%
B. CHALLENGE EXPOSURE
- No. of exposures: single exposure
- Day of challenge: day 28
- Exposure period: 6 hours
- Test groups: 20 animals
- Control group: 10 animals (Test substance treated)
- Site: right flank
- Concentrations: 1.0%
- Evaluation (hr after challenge): 6, 24, 48, 72 hours - Challenge controls:
- 10 control animals were used in the main study.
- Positive control substance(s):
- not required
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1.0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- 20 animals displayed no effects
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1.0%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: 20 animals displayed no effects.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1.0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- 20 animals displayed no effects
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1.0%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: 20 animals displayed no effects.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1.0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- 20 animals displayed no effects
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1.0%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: 20 animals displayed no effects.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1.0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- 20 animals displayed no effects
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1.0%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: 20 animals displayed no effects.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 1.0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- 20 animals displayed no effects
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 1.0%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: 20 animals displayed no effects.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 1.0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- 20 animals displayed no effects
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 1.0%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: 20 animals displayed no effects.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Under the experimental condition chosen, test substance was assessed as non-sensitising to the skin.
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