Registration Dossier
Registration Dossier
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EC number: 279-791-1 | CAS number: 81646-13-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008-05-07 till 2008-06-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD TG 406)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Docosyltrimethylammonium methyl sulphate
- EC Number:
- 279-791-1
- EC Name:
- Docosyltrimethylammonium methyl sulphate
- Cas Number:
- 81646-13-1
- Molecular formula:
- C25H54N.CH3O4S
- IUPAC Name:
- N,N,N-trimethyldocosan-1-aminium methyl sulfate
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: Charles River Deutschland GmbH
- Age at study initiation: 4-5 weeks
- Weight at study initiation: 336 - 345 g
- Housing: Individually in Makrolon type-4 cages with standard softwood bedding
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 guinea pig breeding / maintenance diet, at libidum
- Water (e.g. ad libitum): Community tap water from Füllinsdorf, ad libitum
- Acclimation period: 2008-05-07 to 2008-05-19
ENVIRONMENTAL CONDITIONS
- Temperature (°C): room temperature 22 ± 3 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- MAIN STUDY
A: INDUCTION EXPOSURE (TEST GROUP) (intradermal injections and epidermal induction)
Day 1: three intradermal injections/animal (0.1 mL each)
- FCA/physiological saline, 1:1
- 5% test item in purified water
- 5% test item in a 1:1 mixture FCA/physiological saline
Day 8: 0.3 g epicutaneously (50% of test item)
B. CHALLENGE EXPOSURE
Day 22: 0.2 mL of test item (3%) on 5 x 5 cm area on the left flank; 0.2 mL vehicle (purified water) on 5 x 5 cm area on the right flank
Day 23: 3 hrs and 24 hrs after dressing removal skin reactions were checked.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- MAIN STUDY
A: INDUCTION EXPOSURE (TEST GROUP) (intradermal injections and epidermal induction)
Day 1: three intradermal injections/animal (0.1 mL each)
- FCA/physiological saline, 1:1
- 5% test item in purified water
- 5% test item in a 1:1 mixture FCA/physiological saline
Day 8: 0.3 g epicutaneously (50% of test item)
B. CHALLENGE EXPOSURE
Day 22: 0.2 mL of test item (3%) on 5 x 5 cm area on the left flank; 0.2 mL vehicle (purified water) on 5 x 5 cm area on the right flank
Day 23: 3 hrs and 24 hrs after dressing removal skin reactions were checked.
- No. of animals per dose:
- 5 control animals (females)
10 test animals (females) - Details on study design:
- RANGE FINDING TESTS:
A: intradermal injections:
Four intradermal injections (0.1 mL/site) of a 1:1 (v/v) mixture of Freund's Complete Adjuvant/physiological saline (day 1) (shaved neck of one guinea pig)
Four intradermal injections (0.1 mL/site) at concentrations of A = 15 %, B = 10 % and C = 5 % of the test item in purified water (day 7) (clipped flank of the same guinea pig)
B: epidermal applications:
Four intradermal injections (0.1 mL/site) of a 1:1 (v/v) mixture of Freund's Complete Adjuvant/physiological saline (day 1) (shaved neck of two guinea pigs)
Epidermal application with the test item at D = 50 %, E = 25 %, F = 5 % and G = 10 % in purified water (day 7), (shaved flank of the same guinea pigs)
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal/epicutaneous)
- Exposure period: injected/48 hrs occlusive
- Test groups: scapular region
- Control group: only vehicle (purified water)
- Frequency of applications: 1 / 1
- Duration: 0 - 8 days
- Concentrations: 5% epidermal; 50% epicutaneous
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 22
- Exposure period: 24 hrs
- Site: left flank (test item); right flank: purified water
- Concentrations: 3% epicutaneous
- Evaluation (hr after challenge): 3 hrs and 24 hrs after dressing removal
- Positive control substance(s):
- yes
- Remarks:
- ALPHA-HEXYLCINNAMALDEHYDE
Results and discussion
- Positive control results:
- Skin Effects after epidermal Induction :
Discrete/patchy erythema was observed in all animals at the 24- and 48-hour reading after treatment with the test item at 50 % in purified water.
Skin Effects after Challenge:
No positive/skin reactions were observed in the animals when treated with either purified water only or when treated with the test item at 3 % in purified water.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5% i.d., 50% epic., 3% epic.
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5% i.d., 50% epic., 3% epic.. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5% i.d., 50% epic., 3% epic.
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5% i.d., 50% epic., 3% epic.. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- 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. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- 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. Clinical observations: none.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the above mentioned findings in an adjuvant sensitization test (M&K-test) in guinea pigs and in accordance to Commission Directive 2001/59/EC, the submission substance does not have to be classified and labelled as a skin sensitizer.
- Executive summary:
The sensitization potential of the submission substance was evaluated in guinea-pig according to the Maximization-Test by Magnusson and Kligman.
The intradermal induction of sensitization in the test group was performed in the nuchal region with a 5 % dilution of the test item in purified water and in an emulsion of Freund's Complete Adjuvant (FCA)/physiological saline. The epidermal induction of sensitization was conducted for 48 hours under occlusion with the test item at 50 % in purified water one week after the intradermal induction. The animals of the control group were intradermally induced with purified water and FCA/physiological saline and epidermally induced with purified water under occlusion.
Two weeks after epidermal induction the control and test animals were challenged by epidermal application of the test item at 3 % in purified water and purified water alone under occlusive dressing.
Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing.
No toxic signs were evident in the guinea pigs of the control or test group. No deaths occurred. No skin reactions were observed after the challenge treatment with the submission substance at 3 % in purified water or purified water alone in neither the control group nor the test group.
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