Registration Dossier
Registration Dossier
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EC number: 618-804-0 | CAS number: 919-94-8
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: Modern GLP compliant guideline study, no restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- UK Department of Health, 29 January 2009
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 2-ethoxy-2-methylbutane
- EC Number:
- 618-804-0
- Cas Number:
- 919-94-8
- Molecular formula:
- C7H16O
- IUPAC Name:
- 2-ethoxy-2-methylbutane
- 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
Constituent 1
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.
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