p-tert-butylphenyl 1-(2,3-epoxy)propyl ether

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to the O.E.C.D. test guideline no. 429 with GLP compliance.

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

not specified

GLP compliance:

yes

Remarks:

with test substance characterization.

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

p-tert-butylphenyl 1-(2,3-epoxy)propyl ether

EC Number:

221-453-2

EC Name:

p-tert-butylphenyl 1-(2,3-epoxy)propyl ether

Cas Number:

3101-60-8

Molecular formula:

C13H18O2

IUPAC Name:

2-[(4-tert-butylphenoxy)methyl]oxirane

Constituent 2

Reference substance name:

p-tert-butylphenyl-1-(2,3)-epoxypropyl ether

IUPAC Name:

p-tert-butylphenyl-1-(2,3)-epoxypropyl ether

Constituent 3

Reference substance name:

Oxirane, 2-((4-(1,1-dimethylethyl)phenoxy)methyl)-

IUPAC Name:

Oxirane, 2-((4-(1,1-dimethylethyl)phenoxy)methyl)-

Test material form:

other: Liquid at room temperature.

Details on test material:

As per IUCLID5 Sections 1.1. 1.2. and 4.1.

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

The mice were purchased from Harlan Winkelmann GmbH, Borchen, Germany. The animals were housed in Makrolon type I cages in fully air- conditioned rooms in which a central air-conditioning system ensured a temperature in the range of 20—24 °C and a relative humidity in the range of 30—70%. The illumination period was as follows: 12 h light (6.00 a.m.—6.00 p.m.) and 12 h darkness (6.00 p.m.—6.00 a.m.). Tap water and diet was provided ad libitum.

Study design: in vivo (LLNA)

Vehicle:

other: Acetone

Concentration:

The test substance was applied at concentrations of 0.1, 0.3 and 1.0 % v/v

No. of animals per dose:

6

Details on study design:

For the study, groups of 6 female CBA mice were treated with different concentrations of the test substances in acetone or with acetone alone (vehicle control). Twenty five microliter per ear of the respective test substance preparation was applied to the dorsum of both ears for three consecutive days. The control group was treated solely with 25 uL per ear of the vehicle acetone.

Three days after the last application, the mice were injected intravenously (i.v.) with 20 uCi of [3H1-thymidine in 250 uL of sterile saline into a tail vein. About 5 h after the [3H1-thymidine injection, the mice were sacrificed and the auricular lymph nodes on both sides were removed and the weight of each animal’s pooled lymph nodes was determined. Lymph node response was evaluated by measuring the cellular content and [3H]-thymidine incorporation into lymph node cells (indicators of cell proliferation). To this end, single cell suspensions were prepared from the pooled lymph nodes of each animal as soon as possible after dissection by carefully passing the lymph nodes through an iron mesh (mesh size 200 l.tm) into 6 mL of phosphate-buffered physiological saline. Cell Suspensions were washed twice with phosphate buffered saline (PBS) and precipitated with 5% trichloroacetic acid (TCA). Each precipitate was transferred to scintillation fluid and incorporation of [3H}-thymi- dine into the cells was measured in a beta-scintillation counter.

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

Statistics:

For cell counts, [3H]-thymidine incorporation and lymph node weights the WILCOXON test was applied.

Results and discussion

Positive control results:

Positive Control % Concentration Stimulation Index
_________________________________________________________
3 4.56
10 6.63
30 9.86
_________________________________________________________

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Remarks on result:

other: see Remark

Remarks:

Test Substance % Concentration Stimulation Index ________________________________________________________ 0.1 1.36 0.3 1.68 1.0 14.2 ________________________________________________________

Results 2

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: No data presented.

Applicant's summary and conclusion

Interpretation of results:

sensitising

Remarks:

Migrated information Criteria used for interpretation of results: other: Authors of the piblication.

Conclusions:

Inducing a Stimulation Index of 14.2 at a concentration of 1.0 % v/v the test substance is considered to be a Strong skin sensitiser. The estimated EC3 value is 0.4% v/v.

Executive summary:

The test substance, p-tert-butylphenyl-1 -(2,3 -epoxy)propyl ether was accessed for skin sensitization potential in an O.E.C.D. test guideline no. 429 LLNA study. Inducing a Stimulation Index of 14.2 at a concentration of 1.0 % v/v the test substance is considered to be a Strong skin sensitiser.