Registration Dossier
Registration Dossier
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EC number: 282-810-6 | CAS number: 84434-11-7
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- adopted Feb. 1987
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- adopted May 2008
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Version / remarks:
- adopted August 1998
- Qualifier:
- according to guideline
- Guideline:
- other: Japan MAFF Testing Guideline of 12 Nosan No. 8147
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Ethyl phenyl(2,4,6-trimethylbenzoyl)phosphinate
- EC Number:
- 282-810-6
- EC Name:
- Ethyl phenyl(2,4,6-trimethylbenzoyl)phosphinate
- Cas Number:
- 84434-11-7
- Molecular formula:
- C18H21O3P
- IUPAC Name:
- ethyl phenyl(2,4,6-trimethylbenzoyl)phosphinate
- Details on test material:
- - Name of test material (as cited in study report): Lucirin TPO-L
- Physical state: Liquid, viscous /yellow, clear
- Analytical purity: 95.7g/100g determined by H-NMR spectroscopy
- Purity test date: 2013-04-16
- Lot/batch No.: Mischung 120204
- Expiration date of the lot/batch: May 29th, 2015
- Storage condition of test material: Room temperature; under light exclusion
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, 97633 Sulzfeld, Germany
- Age at study initiation: males: app. 8 weeks, females app. 12 weeks
- Weight at study initiation: males: 229g, females 208g, on average
- Fasting period before study: no
- Housing: single in Makrolon type III cages
- Diet (e.g. ad libitum): VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 3°C
- Humidity (%): 30-70%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12h/12h
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: at least 10% of total body surface
- Type of wrap if used: 4 layers of absorbent gauze and stretch bandage (Fixomull® Stretch (adhesive fleece)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsing with warm water after removal of the dressing
- Time after start of exposure: 24h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.77ml/kg - Duration of exposure:
- 24h
- Doses:
- 2000mg/kg b.w.
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: several times on the day of administration, daily thereafter
- Frequency of weighing: weekly
- Necropsy of survivors performed: yes
- Other examinations performed: Scoring of skin findings according to Draize 30-60minutes after removal of the dressing
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality occured
- Mortality:
- none
- Clinical signs:
- other: none
- Gross pathology:
- no abnormalities detected
- Other findings:
- no local effects
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the test the acute dermal LD50 of the registered substance was found to be ≥2000 mg/kg bw in the rat.
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