Registration Dossier
Registration Dossier
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EC number: 278-355-8 | CAS number: 75980-60-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- adopted July 22nd, 2010
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- adopted May 30th, 2008
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide
- EC Number:
- 278-355-8
- EC Name:
- Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide
- Cas Number:
- 75980-60-8
- Molecular formula:
- C22H21O2P
- IUPAC Name:
- (mesitylcarbonyl)(diphenyl)phosphine oxide
- Details on test material:
- - Name of test material (as cited in study report): Lucirin TPO
- Physical state: yellowish solid
- Analytical purity: 99.5% (w/w), BASF study code 11L00292
- Purity test date: 2011-09-08
- Lot/batch No.: 110053
- Expiration date of the lot/batch: July 19, 2015
- Storage condition of test material: room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Pretest: Charles River, UK; Main Experiment: Harlan Lab. B.V., Netherlands
- Age at study initiation: Pretest: 9-10 weeks, main experiment: 8-9 weeks
- Weight at study initiation: 18.6 - 22.5g
- Housing: groups in makrolon type II or III cages
- Diet (e.g. ad libitum): pelleted standard diet ad lib.
- Water (e.g. ad libitum): tap water ad lib.
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-2°C
- Humidity (%): 31-65%
- Photoperiod (hrs dark / hrs light): 12h/12h
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 10%, 25%, 50% (w/w) (verified analytically)
- No. of animals per dose:
- 5 (2 in the range finding test)
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: maximal achieveable concentration: 50%
- Irritation: 50%: erythema grade 1, slight ear swelling and an increase in ear thickness (33.3%), which was not observed anymore on day 6
25%: No signs of irritation or systemic toxicity were observed
MAIN STUDY
- Criteria used to consider a positive response:
1. at least one concentration of the test item, showing no excessive local irritation, results in an incorporation of ³HTdR ad least 3-fold greater than that recorded in control mice (indicated by the SI)
2. data are compatible with a conventional dose reponse, although allowance must be made (especially at high topical concentrations) for either local toxicity or immunological suppression.
TREATMENT PREPARATION AND ADMINISTRATION:
Sonicating and warming to 37°C was used for formulate the test item. Preparations were freshly made before dosing. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 2.22
- Test group / Remarks:
- 10%
- Parameter:
- SI
- Value:
- 2.96
- Test group / Remarks:
- 25%
- Parameter:
- SI
- Value:
- 3.45
- Test group / Remarks:
- 50%
- Parameter:
- EC3
- Value:
- 792.1
- Parameter:
- other: Disintegrations per minute
- Value:
- 792.1
- Test group / Remarks:
- Control
- Parameter:
- other: Disintegrations per minute
- Value:
- 1 757.5
- Test group / Remarks:
- 10%
- Parameter:
- other: Disintegrations per minute
- Value:
- 2 347.1
- Test group / Remarks:
- 25%
- Parameter:
- other: Disintegrations per minute
- Value:
- 2 742.3
- Test group / Remarks:
- 50%
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Conclusions:
- The test substance was found to be a sensitizer, the EC3 value was calculated to be 27%.
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