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: Guideline study conducted to GLP with full study report available

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
yes (incl. certificate)
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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

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 (non-LLNA)

Positive control substance(s):
no

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
Remarks on result:
other: Vehicle: na 25%v/v: 2.16 (Negative) 50%v/v: 3.42 (Positive) 100% v/v: 7.22 (Positive)
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.