11-(heptylamino)undecanoic acid

Skin sensitisation

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

Test material information

Constituent 1

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)

Results

Results 1

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

Results 2

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.