Registration Dossier

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: Modern GLP compliant guideline study, no restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
UK Department of Health, 29 January 2009
Type of study:
mouse local lymphnode assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): TAEE, tert-amyl ethyl ether, CAS No. 919-94-8
- Lot/batch No.: 00931302
- Description: colourless liquid
- Purity: 99.4%
- Date received: 26 September 2008

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
100%, 50%, 25%
No. of animals per dose:
5
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Statistics:
Individual and group mean disintegrations per minute were assessed for dose response relationships by analysis of homogeneity of variance and one way ANOVA followed, by pairwise comparisons using either Dunnett's Multiple Comparison test (homogeneous data) or Dunnett's T3 Multiple Comparison Method (non-homogeneous data).

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: Test 25% v/v: 1.12 (negative) Test 50%: 1.04 (negative) Test 100%: 2.25 (negative) Positive control: 6.48 (positive)
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: Control (AAO) 1000.82 +/- 435.19 Test 25% v/v 1119.53 +/- 498.08 Test 50% 1043.18 +/- 560.26 Test 100% 2254.61 +/- 1222.02 Positive control 6483.97 +/- 2420.15 * * = P<0.05

Applicant's summary and conclusion

Executive summary:

The sensitisation potential of tert-amyl ether (TAEE, CAS No 919 -94 -8) was assessed using the murine local lymph node (method B42 of Commission Directive 2004/73/EEC) where it gave Stimulation Indices less 3 when tested at concentrations of 100%, 50% or 25% v/v in acetone/olive oil (4:1). α-Hexy1cinnamaldehyde (positive control substance) gave a Stimulation Index of greater than 3 when tested at 15% v/v in acetone/olive oil (4:1). According to interpretation criteria applicable to the method, the results demonstrate that the test substance is not a skin sensitiser.