Registration Dossier

Administrative data

Endpoint:
skin sensitisation
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study, to GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of 6-ethyl-3-methyloct-5-en-1-ol and 6-ethyl-3-methyloct-6-en-1-ol
Molecular formula:
C11H22O
IUPAC Name:
Reaction mass of 6-ethyl-3-methyloct-5-en-1-ol and 6-ethyl-3-methyloct-6-en-1-ol
Test material form:
other: liquid
Details on test material:
Identity: Super Muguet
Description: Colourless to pale yellow liquid
Batch Number: 9000408259
Purity: 99.9%
Stability: Stable under storage conditions
Expirt Date: 08 Dec 2002
Stability of test item formulation: Unkown and therefore excluded from Statement of Compliance
Storage Conditions: In the original container at room temperature (17 - 20 °C), away from direct sunlight.
Safety Precautions: Routine hygenic procedures (gloves, goggles, face mask)

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
Test system: Mice, CBA/Jlbm(SPF)
Rationale: Recognised as the recommended test system
Source: RCC Ltd., Biotechnology & Animal Breeding Division, Wolferstrasse 4, CH-4414, Fullinsdorf, Switzerland
Number of animals per group: 4
Number of control group: 1
Age: 7 - 12 weeks (beginning of acclimatization)
Body weight: 16.2 - 22.2 g (beginning of acclimatization period)
Identification: By unique cage number and individual colour code
Randomization: Randomly selected by computed algorithm at time of delivery
Acclimatization: Under test conditions after health examination. Only animals without any signs of illness were used for the study.

Study design: in vivo (LLNA)

Vehicle:
other: ethanol 70 %
Concentration:
0.5 %, 5 %, 50 % and 100 % (undiluted) in ethanol 70%
No. of animals per dose:
4
Details on study design:
In order to study a possible allergenic potential of SUper Mugiet four groups of four female mice each were tested withthe test item at concentrations of 0.5 %, 5 %, 50 % and 100 % (undiluted) in ethanol 70 % by topical application to the dorsum of each ear lobe (left and right) on three consecutive days. A control group of four mice was treated with the vehicle (ethanol 70 %) only. Five days after the first topical application the mice were injected intravenously into a tail vein with radio-labelled thymidine (3H-methyl thymidine). Approximately five hours after intravenous 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 washed subsequently 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 β-scintillation counter.
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

Positive control results:
Alpha-hexycinnamaldehyde was regarded as a sensitizer when tested at concentrations of 10 % and 25 %. At a concentration of 5 % the test item was found to be a non-sensitizer.

In vivo (LLNA)

Results
Parameter:
SI
Remarks on result:
other: Group 2 (0.5 %) S.I = 1.3 Group 3 (5 %) S.I = 1.6 Group 4 (50 %) S.I = 6.0 Group 5 (100 %) S.I = 8.7

Any other information on results incl. tables

No deaths occurred during the study.

No symptoms of local toxicity at the ears of the animals and no systemic findings were observed during the study.

The body weight of the animals, recorded at the start of acclimatization period and prior to necropsy, was within the range commonly recorded for animals of this strain and age.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Moderate Criteria used for interpretation of results: EU
Conclusions:
The test item Super Muguet was found to be a non-sensitizer when tested as 0.5 % and 5 % dilutions.
Super Muguet showed allergenic potency when tested at concentrations of 50 % and 100 % (undiluted).
Executive summary:

In an in vivo LLNA test, conducted to GLP and according to the OECD Guideline 406 and 429, Super Muguet was found to be a non-sensitizer when tested as 0.5 % and 5 % dilutions. However, Super Muguet showed allergenic potency when tested at concentrations of 50 % and 100 % (undiluted). The EC3 is 19.32.