Registration Dossier
Registration Dossier
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EC number: 700-736-9 | CAS number: 2149571-40-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 April 2013 to 08 May 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to OECD and EEC guidelines and in compliance with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
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:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Certificate of compliance from UK GLP Monitoring Authority
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- (1R,2S,10R,11S)-tetracyclo[9.2.1.0²,¹⁰.0³,⁸]tetradeca-3(8),4,6,12-tetraene
- EC Number:
- 700-736-9
- Cas Number:
- 2149571-40-2
- Molecular formula:
- C14H14
- IUPAC Name:
- (1R,2S,10R,11S)-tetracyclo[9.2.1.0²,¹⁰.0³,⁸]tetradeca-3(8),4,6,12-tetraene
- Details on test material:
- - Name of test material (as cited in study report): MTF
- Substance type: Organic
- Physical state: Transparent Liquid
- Analytical purity: ca. 100%
- Lot/batch No.: M1204
- Expiration date of the lot/batch: 31 December 2015
- Storage condition of test material: room temperature (20 deg C) under nitrogen
- Other:
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 18.3 - 21.8 g
- Housing: 2 per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 60 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23 deg C
- Humidity (%): 40 - 70%
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light
IN-LIFE DATES: From: 17 April 2013 To: 07 May 2013
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 10, 25 and 50% v/v
- No. of animals per dose:
- 2 per dose
- Details on study design:
- Preliminary investigation:
Two female mice (per concentration) received a daily application of 25 µL of appropriate concentration of the test substance to the dorsal surface of each ear for three consecutive days (Days 1-3). The test substance was applied to the dorsal surface of each ear using an automatic micropipette and was spread
over the entire dorsal surface of the ear using the tip of the pipette.
Main phase
Groups of four mice were treated at one of three concentrations of the test substance. The mice were treated by daily application of 25 µL of the appropriate
concentration of the test substance to the dorsal surface of each ear for three consecutive days (Days 1-3). The test was applied to the dorsal surface of each ear using an automatic micropipette and was spread over the entire dorsal surface of the ear using the tip of the pipette. Further groups of four mice received the vehicle alone or the positive control substance in the same manner. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- The SI for the positive control substance hexyl cinnamic aldehyde (HCA) was 6.5 which demonstrates the validity of this study.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 3.8
- Test group / Remarks:
- 10%
- Key result
- Parameter:
- SI
- Value:
- 7.8
- Test group / Remarks:
- 25%
- Key result
- Parameter:
- SI
- Value:
- 7.3
- Test group / Remarks:
- 50%
- Key result
- Parameter:
- EC3
- Value:
- 8.7
- Remarks on result:
- positive indication of skin sensitisation based on QSAR/QSPR prediction
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- MTF is regarded as a potential skin sensitizer. The EC3ex value was calculated to be 8.3 % v/v.
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