4-Piperidinone, 2,6-diethyl-2,3,6-trimethyl-1-(1-phenylethoxy)-

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study performed according to OECD-Guideline under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Details on test material:

ldentity: TKA 40270 (CGPS 345)

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

male/female

Details on test animals and environmental conditions:

Test animals: Mice, CBA/CaolaHsd

Source: Harlan Netherlands
B.V. Postbus 6174
NL - 5960 AD Horst / The Nether!ands

Number of animals for the main study: 16 females
Test system
Rationale
Source
Number of animals for
the pre-test (non-GLP)
Number of animals for
the main study
Number of animals per group
Number of test groups
Number of control (vehiele) group
Age
Body weight
Identification
Randomization
Acclimatizatiori

Study design: in vivo (LLNA)

Vehicle:

acetone/olive oil (4:1 v/v)

Concentration:

5%, 10%, 25% w/v

No. of animals per dose:

4 for concentration 10 % (w/v)
4 for concentration 25% (w/v)
4 for control

Details on study design:

Three groups each of four female mice were treated daily with the test item at concentrations of 5 % 10 % and 25% (w/v) in acetone:olive all, 4:1 (v/v) by topical application to the dorsum of each ear lobe (left and right) for three consecutive days. A control group of four mice was treated with the
vehicle (acetone:olive oil, 4:1 (v/v)) only. Five days after the first topical application the mice were injected intravenously into a tail vein with
radio-Iabelled thymidine (3H-methyl thymidine). Approximately five hours after intraravenous injection, the mice were sacrificed, the draining
auricular lymph nodes excised and pooled per group. Single cell suspensions of lymph node cells were prepared from pooled lymph nodes which
were subsequently washed and incubated with trichloroacetic acid overnight. The proliferative capacity of pooled lymph node cells was determined
by the incorporation of 3H methyl-thymidine measured in a Oscintillation counter.

Results and discussion

Positive control results:

STIMULATION INDICES of 1.5, 2.3 and 8.4 were determined with the test item (positive control) at concentrations of 5%, 10% and 25 % (w/v),
respectively, in acetone:olive oH, 4:1 (v/v).
A test item is regarded as a sensitizer in the LLNA if the exposure to one or more test concentrations resulted in 3-fold or greater increase in
incorporation of HTdR compared with concurrent controls, as indicated by the STIMULATION INDEX (S.I.).
The test item ALPHA-HEXYLCINNAMALDEHYDE was found to be a skin sensitizer and an EC3 value of 11.7 % (wlv) was derived.

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Remarks on result:

other: See: Table under "Remarks on results including tables and figures"

Results 2

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: See: Table under "Remarks on results including tables and figures"

Any other information on results incl. tables

Test item concentration % (w/v)		Measurement dpm	dpm - BG	Number of lymph nodes	dpm per lymph node	S.I.
-	BG I	2	-	-	-	-
-	BG II	2	-	-	-	-
-	CG 1	2787	2785	8	348
5	TG 2	3229	3227	8	403	1.2
10	TG 3	5970	5968	8	746	2.1
25	TG 4	9776	9774	8	1222	3.5

BG = Background (1 ml 5 % trichloroacetic acid) in duphicate

GG = Control Group

TG = Test Group

S.I.= Stimulation Index

Applicant's summary and conclusion

Interpretation of results:

sensitising

Remarks:

Migrated information

Conclusions:

The test item was found to be a skin sensitizer and an EC3 value of 19.6 % (wiv) was derived.