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Registration Dossier
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EC number: 229-761-9 | CAS number: 6711-48-4
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: Guideline study with GLP
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:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- Cited as Directive 84/449/EEC, B.6
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- LLNA method was not available by the time the study was conducted
Test material
- Reference substance name:
- N'-[3-(dimethylamino)propyl]-N,N-dimethylpropane-1,3-diamine
- EC Number:
- 229-761-9
- EC Name:
- N'-[3-(dimethylamino)propyl]-N,N-dimethylpropane-1,3-diamine
- Cas Number:
- 6711-48-4
- Molecular formula:
- C10H25N3
- IUPAC Name:
- N'-[3-(dimethylamino)propyl]-N,N-dimethylpropane-1,3-diamine
- Details on test material:
- - Name of test material (as cited in study report): Bis-(3-dimethylaminopropyl)-amin
- Physical state: liquid, slight yellowish
- Analytical purity: 98.5 %
- Lot/batch No.: 19b/KW 23857369582-8
- Storage: room temperature
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: Lippische Versuchstierzucht, Hagemann GmbH & Co. KG, Extertal, Germany
- Age at study initiation: young adult animals
- Weight at study initiation: 292 - 341 g
- Housing: 5 animals per cage
- Diet: Kliba Labordiaet 341 (Kaninchen-Meerschweinchen-Haltungsdiaet), ad libitum
- Water: tap water ad libitum (about 2 g of ascorbic acid per 10 L water was added to the drinking water twice a week).
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
The feed used in the study was assayed for chemical and microbiological contaminants. The dinking water is regularly assayed for chemical contaminants by the municipal authorities of Frankenthal and the Technical Services of BASF AG as well as for the presence of germs by a contract laboratory.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Intradermal induction: test substance 0.1 % in 0.9% aqueous NaCl-solution or in Freund's adjuvant/0.9% aqueous NaCl-solution (1:1) or 0.9% aqueous NaCl-solution.
Percutaneous induction: test substance 1 % in aqua bidest.
Challenge: test substance 0.5 % in aqua bidest.
(concentrations were selected on the basis of a pretest)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Intradermal induction: test substance 0.1 % in 0.9% aqueous NaCl-solution or in Freund's adjuvant/0.9% aqueous NaCl-solution (1:1) or 0.9% aqueous NaCl-solution.
Percutaneous induction: test substance 1 % in aqua bidest.
Challenge: test substance 0.5 % in aqua bidest.
(concentrations were selected on the basis of a pretest)
- No. of animals per dose:
- Test group: 10
Control groups: 5/group (2 control group) - Details on study design:
- RANGE FINDING TESTS:
2 x 2 cm filter paper strips soaked in the test substance formulation (about 0.15 g) were applied to the skin of the flanks under an occlusive dressing. The test substance was applied 2 times for 24 h within a period of 96 hours in order to detect non-specific phenomena that are not caused by a sensitisation reaction but could possibly be attributed to a shift in the irritation threshold.
- Site of application: flank
- No. of animals: 4 per test concentration
- Readings: about 24 and 48 h after the beginning of application
- Evaluation: according to the Draize Scoring System
MAIN STUDY
A. 1) INDUCTION EXPOSURE (intradermal)
- No. of exposures: 6 intradermal injections in groups of two per animal
- Test group (10 animals): 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; middle row: 2 injections each of 0.1 mL of the test substance formulation; back row: 2 injections each of 0.1 mL Freund's adjuvant/0.9% aqueous NaCl-solution (1:1) with test substance
- Control groups (5 animals per group): The animals were given the same injections but without test subtsance, only with the formulating agent
- Site: shoulder
- Readings: 24 h after the beginning of application
- Evaluation: according to the Draize Scoring System
2) INDUCTION EXPOSURE (percutaneous)
- No. of exposures: 1 percutaneous exposure 1 week after intradermal induction
- Amount applied: 2 x 4 cm filter paper strips soaked in the test substance formulation (about 0.3 g) were applied to the skin of the shoulder under an occlusive dressing
- Exposure period: percutaneous exposure: 48 h
- Control groups: no treatment
- Site of application: shoulder, same area as intradermal application
- Readings: 24 h after the beginning of application
- Evaluation: according to the Draize Scoring System
B. CHALLENGE EXPOSURE
- No. of exposures: single percutaneous exposure
- Duration of exposure: 24 h
- Day of challenge: 21 days after intradermal induction
- Site: intact flank
- Concentrations: non-irritant concentration (2 x 2 cm filter paper strips soaked with about 0.15 g of the test substance formulation)
- Control groups: control group 1 treated like test group; control group 2 remained untreated
- Evaluation (hr after challenge): 24 and 48 h after removal of the patch
- Site of application: intact flank - Positive control substance(s):
- yes
- Remarks:
- Performed in a separate study twice a year in the laboratory with alpha-hexylcinnamaldehyde.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Group:
- positive control
- Remarks on result:
- other: Performed in a separate study twice a year in the laboratory with alpha-hexylcinnamaldehyde.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.5%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.5%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.5%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.5%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5%
- 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: 0.5%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5%
- 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: 0.5%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
The intradermal induction with 0.1% test substance preparations caused well-defined erythema and slight edema were observed at the injection sites of the control group animals and test group animals. The control group animals which were treated with 0.9% aqueous NaCl-solution did not show any skin reactions.
After the percutaneous induction with a 1% test substance preparation incrustation, partially open (caused by the intradermal induction) could be observed in addition to well-defined erythema and slight edema in all test group animals.
After the challenge with a 0.5 % test substance preparation the animals of control group and the test group, animals did not show any skin reactions 24 and 48 hours after removal of the patches.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
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