Registration Dossier

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From December 1989 to July 1990
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The study was performed before implementation of the LLNA method

Test material

Constituent 1
Chemical structure
Reference substance name:
11-(heptylamino)undecanoic acid
EC Number:
271-487-7
EC Name:
11-(heptylamino)undecanoic acid
Cas Number:
68564-88-5
Molecular formula:
C18H37NO2
IUPAC Name:
11-(heptylamino)undecanoic acid
Test material form:
solid
Details on test material:
CAS N°. 68564-88-5
Test item appearance : white solid
.Batch number : 091137

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
Cages: stabulation per sexe and per group of 5 or 6 (2 animals for preiinary study) (cage size 560 x 355 x 315 mm) in polystyrène.
Temperature : 17 to 27 °C
Hygrometry: 26 à 56 % H.R.
Lighting: artificial 12 hours per 24 hours (photopériod = 7h30 - 19h30).
- Diet : , ad Jibitum (U.A.R. formule 114 - U.A.R., Villemoisson - 91360 Epinay S/Orge - France).
- Eau : filtrated, ad libitum. regular bacteriological checking

- Acclimatation period :
préliminairy study : 20 jours before dosing
main study : 12 jours before dosing

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
63, 5%
Day(s)/duration:
48 hours during 7 days
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
63,5%
Day(s)/duration:
48 hours
No. of animals per dose:
10 males and 10 females (main study)
Details on study design:
Twenty treated guinea-pigs (10 males and 10 females): no control group, treated animals served as control.
On day 1, in presence of Freund's complete adjuvant (by intradermal route), the sensitization potential of the test substance was evaluated after a 7-day induction period during which time the animais were treated topicaly with the test substance . The 7 applications corresponding to the induction phase with the test item topically applied as a paste at 63,5% in distilled water at a rate of 0,5 ml per animal during 48 hours (occlusive). On day 29, the challenge application were conducted with the test article as a paste at 63.5 %distilled water and at the rate of 0.5 ml per guinea-pig during 48 hours at occlusive exposure.
Macroscopic cutaneous examinations were performed according to a given scale to the challenge application site, 6, 24 and 48 hours after removal occlusive patches. Histopathological examination of the skin was carried out in the guinea-pig showing a doubtful reaction at 6 hours.

Challenge controls:
No
Positive control substance(s):
yes

Results and discussion

Positive control results:
100% of sensitizing animals were obtained with a reference substance using the same protocol (Dihydrocoumarine)

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0,5 ml per animal of test item in paste form at 63,5 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0,5 ml per animal of test item under taste form at 63,5 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under our experimental conditions and according to the maxirnization method established by Magnusson and Kligman, no cutaneous reactions attributable to the sensitization potential of the test substance, N-heptyl-11-aminoundecanoic acid(NHAU), in its original form were observed in guinea-pigs.
Executive summary:

Evaluation of the cutaneous delayed hypersensitivity of the test article was performed in the albino Dunkin-Hartley guinea-pig, according to a maximized protocol using one treated group of 20 animals of both sexes.
The 7 applications corresponding to the induction phase and the challenge application were conducted with the test article as a paste at 63.5 %distilled water and at the rate of 0.5 ml per guinea-pig. Macroscopic cutaneous examinations were performed according to a given scale to the challenge application site, 6, 24 and 48 hours after removal occlusive patches. Histopathological examination of the skin was carried out in the guinea-pig showing a doubtful reaction at 6 hours. Macroscopic and histopatholgical exmaination revealed any pathological lesion of delayed hypersenstivity in any of the 20 treated animals. From the results obtained under the experimental conditions employed, the test article, N-heptyl-11-aminoundecanoic acid(NHAU), did not provoke any reaction of cutaneous sensitization.