Registration Dossier
Registration Dossier
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EC number: 240-347-7 | CAS number: 16219-75-3
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:
- guideline study
- Remarks:
- Guideline study conducted to GLP with full study report available
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 5-ethylidene-8,9,10-trinorborn-2-ene
- EC Number:
- 240-347-7
- EC Name:
- 5-ethylidene-8,9,10-trinorborn-2-ene
- Cas Number:
- 16219-75-3
- Molecular formula:
- C9H12
- IUPAC Name:
- 5-ethylidenebicyclo[2.2.1]hept-2-ene
- Details on test material:
- - Name of test material (as cited in study report): 5-ethylidene-8,9,10-trinorborn-2-ene
- Substance type: hydrocarbon
- Physical state: clear, colourless liquid
- Lot/batch No.: not given
- Expiration date of the lot/batch: 30 April 2011
- Storage condition of test material: 4 Celsius in dark
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source:
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 15-23 g
- Housing: Individually housed in suspened polypropylene cages with stainless steel mesh lids on softwood flake bedding
- Diet: Certified rat and mouse diet from an accredited supplier, ad libitum
- Water : mains tap water ad libitum.
- Acclimation period: at least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 Celsius (target)
- Humidity (%): 30 - 70 target
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):
IN-LIFE DATES: From: To:
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 25%, 50%, 100% (undiluted)
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:
- Number of animals: 1:
- Protocol: Daily application of 25ul to dorsal surface of each ear for 3 consecutive days.
- Irritation: none observed.
MAIN STUDY
- Criteria used to consider a positive response: 3 fold increase in dpm
TREATMENT PREPARATION AND ADMINISTRATION: Mice treated with undiluted test material or at concentrations of 25 and 50% in acetone/olive oil (4:1). Daily application of 25ul to the dorsal surface of each ear for 3 consecutive days. Five days following first topical application (Day 6) all mice injected via the tail vein with 250ul of phosphated buffer saline containing 3H-methyl thymidine giving a total dose of 20uCi to each mouse. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- Positive
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 2.16
- Test group / Remarks:
- 25% v/v in acetone/olive oil 4:1
- Parameter:
- SI
- Value:
- 3.42
- Test group / Remarks:
- 50% v/v in acetone/olive oil 4:1
- Parameter:
- SI
- Value:
- 7.22
- Test group / Remarks:
- 100% v/v in acetone/olive oil 4:1
- Parameter:
- EC3
- Remarks:
- (%)
- Value:
- 41.7
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Vehicle: 891.54/node 25% v/v: 1929.52/node 50% v/v: 3052.52/node 100% v/v: 6440.82/node
Any other information on results incl. tables
The concentration of ENB expected to cause a 3-fold increase in 3HTdR incorporation (EC3) was calculated to be 41.7% v/v in acetone/olive oil 4:1.
The results suggest that ENB is a weak sensitiser.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- ENB is a sensitizer as at last one concentration resulted in a 3-fold or greater increase in tritiated TdR incorporation compared with controls
- Executive summary:
In this approved study conducted under GLP, 5-ethylidene-norborn-2-ene was shown to be a sensitizer at 50% v/v and neat. The results suggest that ENB is a weak sensitiser.
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