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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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
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
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
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.
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
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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

There is one reliable and relevant study available investigating the skin sensitizing potential of 1-Butanaminium, N,N-dibutyl-N-methyl-, methyl sulfate.

OECD Guideline similar Study:

The substance 1-Butanaminium, N,N-dibutyl-N-methyl-, methyl sulfate was tested for its sensitizing effect on the skin of the guinea pig in the MaximizationTest based on the method of Magnusson and Kligman (similar to OECD 406) under GLP. The intradermal induction with 5% test substance preparations caused moderate and confluent erythema with swelling in all test group animals. After the percutaneous induction with a 50% test substance preparation incrustation, partially open (caused by the intradermal induction) could be observed in addition to moderate and confluent erythema with swelling in all test group animals. A challenge was performed 14 days after the percutaneous induction. The number of animals with skin findings after the challenge (Test substance 25% in aqua bidest.) are summarized as follows: Control 0/5; Test group 0/10 with positive reactions. (reading at 24 h and/or 48 h after the removal of the patch) Based on the results of this study it was concluded that 1-Butanaminium, N,N-dibutyl-N-methyl-, methyl sulfate does not have a sensitizing effect on the skin of the guinea pig in the Maximization Test under the test conditions chosen (BASF, 1998).

This study is the only avaiable information, but reliable and good documented and therefore integrated as key study.

Assessment:

As there were no positive reaction in a Magnusson Kligman test the substance is not rated as skin sensitizing.


Migrated from Short description of key information:
Skin sensitization: Guinea pig, similar to OECD 406, GLP: not skin sensitizing (BASF 1998)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the above information and according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, a classification of the substance as skin sensitizer is not justified.

Skinsensitizer:

-GHS: no classification

-DSD: no classification