Registration Dossier
Registration Dossier
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EC number: 454-210-6 | CAS number: 13106-24-6
Toxicological information
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline Study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- reduced number of animals in both, control and test group
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- -
- EC Number:
- 454-210-6
- EC Name:
- -
- Cas Number:
- 13106-24-6
- Molecular formula:
- C13 H30 N . C H3 O4 S
- IUPAC Name:
- tributyl(methyl)azanium methyl sulfate
- Details on test material:
- Substance number: 97/272
Batch No.: 601
Date of manufacturing: June 1997
CAS No.: 13106-24-6
Degree of purity/ content: 101 g / 100 g (H-NMR)
Physical state/appearance: Solid (congealed melt), white
Storage conditions: Room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White, Dunkin Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Strain/Quality: Pirbright White, Dunkin Hartley Crl: (HA)BR [SPF]
Origin: Charles River GmbH - Wiga, Kisslegg, FRG
Age of the animals: Young adult animals
Bodly weight range at the beginning of the study: 332 - 367 g
Acclimatization period: 7 days before the beginning of the study in the laboratory for dermal toxicity.
Air conditions: The animals were housed in fully air-conditioned rooms in which a central air-conditioning system ensured a temperature in the range of 21 - 25°C and a relative humidity in the range of 30 - 70%. Deviations from these specifications that would have had an adverse effect on the test results did not occur.
Illumination period: 12 h light (6.00 a.m. - 6.00 p.m.); 12 h darkness (6.00 p.m. - 6.00 a.m.)
Type of cage: Makrolon, type IV
No. of animals per cage: 5
Identification of the animals: Ear tattoo
Type of diet: Kliba Labordiät (Kaninchen-Meerschweinchen-Haltungsdiät) ad libitum. Supplier: Firma Klingentalmühle AG, Kaiseraugst, Switzerland
Watering: Tap water ad libitum
Bedding: Granulat Type 3/4
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Intradermal induction: test substance 5% in 0.9% aqueous NaCl-solution or in Freund's adjuvant / 0.9% aqueous NaCl-solution (1 : 1)
Percutaneous induction: test substance 50% in aqua bidest.
Challenge: test substance 25% in aqua bidest.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Intradermal induction: test substance 5% in 0.9% aqueous NaCl-solution or in Freund's adjuvant / 0.9% aqueous NaCl-solution (1 : 1)
Percutaneous induction: test substance 50% in aqua bidest.
Challenge: test substance 25% in aqua bidest.
- No. of animals per dose:
- Control: 5 per control group (challenge control+negativ control)
Test group: 10 - Details on study design:
- Induction:
Intradermal induction: 6 intradermal injections in groups of two per animal were given.
Injections for the control groups: A) front row 2 injections each of 0.1 mL Freund's adjuvant without test substance emulisified with 0.9%-aqueous NaCl-solution in a ratio of 1 :1
B) middle row: 2 injections each of 0.1 mL of the undiluted vehicle
C) back row: 2 injections each of 0.1 mL of a 50% formulation of the vehicle without test substance emulsified with Freund's adjuvant / 0.9% aqueous NaCl-solution (1 :1)
Injections for the test group:
A) front row: 2 injections each of 0.1 mL Freund's adjuvant without test substance emulsified with 0.9% aqueous NaCl-solution in a ratio of 1 :1
B) middle row: 2 injections each of 0.1 mL of a test substance formulation in an appropriate vehicle at the selected concentration.
C) back row: 2 injections each of 0.1 mL Freund's adjuvant/ 0.9% aqueous NaCl-solution (1 : 1) with test substance at the selected concentration.
Site of application: - shoulder
No. of animals: - 2 per test substance concentration
Reading: - 24 h after the beginning of application
Percutaneous induction:
Peroutaneous induction was carried out one week after intradermal induction.
1 mL of the test substance formulation was applied to each animal. The control animals were not treated since the distilled water used as vehicle was not expected to influence the result of the study.
Duration of exposure: - 48 hours
Site of application: - shoulder, same area as in the case of the previous intradermal application
Readings: -48 h after the beginning of application
Challenge
The challenge was performed 14 days after the percutaneous induction.
Amount applied: 0.5 mL of the test substance formulation was applied to each animal.
- The test group and control group 1 were treated with the test substance formulation (control group 2 remained untreated).
Duration of exposure: - 24 hours
Site of application: - intact flank
Readings: -24 and 48 h after the removal of the patch - Challenge controls:
- Control group 1
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: challenge control
- Dose level:
- 25% (0.5 ml)
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: challenge control. Dose level: 25% (0.5 ml). No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: challenge control
- Dose level:
- 25% (0.5 ml)
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: challenge control. Dose level: 25% (0.5 ml). No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% (0.5 ml)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25% (0.5 ml). No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% (0.5 ml)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25% (0.5 ml). No with. + reactions: 0.0. Total no. in groups: 10.0.
Applicant's summary and conclusion
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