Registration Dossier
Registration Dossier
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EC number: 271-547-2 | CAS number: 68585-02-4
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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 17 July 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- False positive results has been reported for some surfactant type chemicals, therefore the LLNA test was considered to be not the adequate in-vivo test method for testing of Octadecanoic acid, reaction products with acetic acid and tetraethylenepentamine.
Test material
- Reference substance name:
- Octadecanoic acid, reaction products with acetic acid and tetraethylenepentamine
- EC Number:
- 271-547-2
- EC Name:
- Octadecanoic acid, reaction products with acetic acid and tetraethylenepentamine
- Cas Number:
- 68585-02-4
- Molecular formula:
- C28H63N5O4
- IUPAC Name:
- acetic acid;N'-[2-[2-(2-aminoethylamino)ethylamino]ethyl]ethane-1,2-diamine;octadecanoic acid
- Test material form:
- solid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Guinea pig / Dunkin-Hartley, Charles River Laboratories, Germany
- Age at study initiation: 29 days
- Weight at study initiation: 300 - 370 g
- Housing: MAKROLON cages (MZK 80/25)
- Diet (e.g. ad libitum): Ms-H V2233 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany)
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 3°C
- Humidity (%): 55% +/- 10%
- Photoperiod (hrs dark / hrs light): about 150 lux at approx. 1.50 m room height) on a 12-hour light/12-hour dark cycle.
- IN-LIFE DATES: From: To: 2017-08-23 to 2017-10-07
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5 mL
- Day(s)/duration:
- day 1 and day 8 each 6 hours exposure
- Adequacy of induction:
- other: undiluted test item (100%) was chosen for the induction
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5 mL
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- control group: 10 animals
test group: 20 animals - Details on study design:
- RANGE FINDING TESTS:
A preliminary test was performed with 3 animals employing a range of concentrations of test item at concentration of 10, 25, 50 or 75% suspensions in aqua ad injectabilia and undiluted.
No changes of the skin were observed in this preliminary test at any concentration the undiluted test item was chosen for the induction and the challenge of the main experiment.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: three, day 1, day 8 and day 15
- Exposure period: 6h
- Test groups: 20 animal - undiluted test substance
- Control group: 10 animals - aqua ad injectabilita
- Site: left side of the flank region
B. CHALLENGE EXPOSURE
- No. of exposures: once
- Day(s) of challenge: day 29 of study
- Exposure period: 6 h
- Test groups: 20 animals - undiluted
- Control group: 10 animals - aqua ad injectabilia
- Site: the posterior untreated flank of treated and control animals
- Evaluation (hr after challenge): 24, 48, 72 h - Positive control substance(s):
- yes
- Remarks:
- alpha-hexyl cinnamaldehyde, The Study with the positive control was conducted in June/July 2017, Report No. 34674
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 30
- Clinical observations:
- no clinical signes
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 30
- Clinical observations:
- no clinical signes
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 85 %
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Octadecanoic acid, reaction products with acetic acid and tetraethylenepentamine is not a dermal sensitizer.
- Executive summary:
In a dermal sensitization study according to OECD guideline 406 with Octadecanoic acid, reaction products with acetic acid and tetraethylenepentamine Dunkin-Hartley guinea pigs were tested using the method of Bühler. The undiluted test substance was used for the induction stages and for the challenge.
No skin reactions were observed in animals exposed with the test item at any stage of the study. The positive controla-hexyl cinnamaldehyde solution revealed sensitising properties in all 20 animals employed.
In this study, Octadecanoic acid, reaction products with acetic acid and tetraethylenepentamine is not a dermal sensitizer.
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