Registration Dossier
Registration Dossier
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EC number: 453-080-8 | CAS number: 154858-16-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004-02-17 to 2004-03-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented guideline conform, scientific GLP report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Tetradecyltrimethylammonium oxalate
- IUPAC Name:
- Tetradecyltrimethylammonium oxalate
- Reference substance name:
- -
- EC Number:
- 453-080-8
- EC Name:
- -
- Cas Number:
- 154858-16-9
- Molecular formula:
- C36H76N2O4
- IUPAC Name:
- bis(trimethyl(tetradecyl)azanium) oxalate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: HsdPoc:DH
- Sex:
- female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- intradermal induction: 0.04 % (test substance in deionized water)
epicutanous induction: 5 % (test substance in deionized water)
epicutanous challenge: 1 % (test substance in deionized water)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- intradermal induction: 0.04 % (test substance in deionized water)
epicutanous induction: 5 % (test substance in deionized water)
epicutanous challenge: 1 % (test substance in deionized water)
- No. of animals per dose:
- Control group: 5
Treatment group: 10 - Positive control substance(s):
- yes
- Remarks:
- ALPHA-HEXYL CINNAMIC ALDEHYDE
Results and discussion
- Positive control results:
- Positve control assay with Alpha-hexyl cinnamic aldehyde
Challenge treatment - control and treatment group:
25 % Alpha-hexyl cinnamic aldehyde in polyethylene glycole 400 (day 22)
Treated area: left flank
Time of observation: approx. 24 hours after removal of the patches (day :24).
24 hours after the challenge treatment, 9/10 animals of the treatment group (90 %) showed a positive reaction during the observation period. The corresponding 5 control animals did not show any reaction to treatment.
Time of observation: approx. 48 hours after removal of the patches (day :25).
48 hours after the challenge treatment, all ten animals of the treatment group (l00 %) showed a positive reaction during the observation period. The corresponding 5 control animals did not show any reaction to treatment.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1% (test substance in deionized water)
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Discrete or patchy up to intense erythema and swelling were observed in the treatment group 24 hours after removal of the occlusive bandage.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1% (test substance in deionized water). No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: Discrete or patchy up to intense erythema and swelling were observed in the treatment group 24 hours after removal of the occlusive bandage..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1 % (test substance in deionized water)
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Discrete or patchy up to intense erythema and swelling were observed in the treatment group 48 hours after removal of the occlusive bandage.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1 % (test substance in deionized water). No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: Discrete or patchy up to intense erythema and swelling were observed in the treatment group 48 hours after removal of the occlusive bandage..
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No skin reactions were observed in the control group 24 and 48 hours after removal of the occlusive bandage.
- Remarks on result:
- other: see Remark
- Remarks:
- 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: No skin reactions were observed in the control group 24 and 48 hours after removal of the occlusive bandage..
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 25 %
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- Discrete or patchy up to intense erythema and swelling were observed in the treatment group 24 hours after removal of the occlusive bandage.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 25 %. No with. + reactions: 9.0. Total no. in groups: 10.0. Clinical observations: Discrete or patchy up to intense erythema and swelling were observed in the treatment group 24 hours after removal of the occlusive bandage..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 25 %
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Discrete or patchy up to intense erythema and swelling were observed in the treatment group 48 hours after removal of the occlusive bandage.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 25 %. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: Discrete or patchy up to intense erythema and swelling were observed in the treatment group 48 hours after removal of the occlusive bandage..
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the present OECD 406 study (Magnusson & Kligman), all of ten animals of the treatment group showed a positive skin response after the challenge procedure. Based on the results of this study Dodigen 5356 AS may cause sensitization by skin contact .
- Executive summary:
In order to evaluate the test substance for its skin sensitizing property, a test was performed in female guinea pigs according to the method of MAGNUSSON & KLIGMAN (OECD 406). Intradermal induction was performed using 0.04 % test substance in deionized water. Dermal induction treatment was carried out with 5 % test substance in deionized water. Challenge treatment was carried out with 1 % test substance in deionized water. Bodyweight of the treated animals were not impaired. The treated animals showed no clinical signs of intoxication throughout the study.
All animals of the treatment group (10/10) were positive in this test (100%) whereas all control animals (5/5) were negative.The validity of the test system is confirmed by the periodically conducted positive control test using Alpha-hexylcinnamaldehyde for the maximization test.
Based on the results of this study the test substance may cause sensitization by skin contact
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