Registration Dossier

Administrative data

Description of key information

Octadecanoic acid, reaction products with acetic acid and tetraethylenepentamine is not a dermal sensitizer. 

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:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
17 July 1992
Deviations:
no
GLP compliance:
yes (incl. certificate)
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.
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
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
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
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 group
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 group
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
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. 

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

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. 

Justification for classification or non-classification

Based on data from a study according to OECD Guideline 406 , Octadecanoic acid, reaction products with acetic acid and tetraethylenepentamine does not need to be classified as skin sensitizer according the criteria of CLP, EU GHS (Regulation (EC) No 1272/2008).