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EC number: 278-355-8 | CAS number: 75980-60-8
Toxicological information
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- adopted Feb. 24th, 1987
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- May 30th, 2008
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Version / remarks:
- 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:
- standard acute method
- Limit test:
- yes
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) (for details see analytical report 11L00292)
- Purity test date: 2011-09-08
- Lot/batch No.: 110053
- Expiration date of the lot/batch: 2015-07-19
- Stability under test conditions: guaranteed by sponsor
- Storage condition of test material: room temperature
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, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: males: app. 8 weeks, females: app. 12 weeks
- Weight at study initiation: males: 230.8g +/- 13.2g, females 204.8g +/- 3.1g
- Housing: single in Markolon type III cages
- Diet (e.g. ad libitum): VRF1(P); SDS Special Diets Services, Altrip, Germany
- Water (e.g. ad libitum): tap water ad lib.
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 3°C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12h/12h
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- olive oil
- Details on dermal exposure:
- TEST SITE
- Area of exposure: app. 40cm²
- Type of wrap if used: air-permeable dressing (4 layers of absorbent gauze (Ph. Eur. supplied by Lohmann GmbH & Co., KG) and stretch bandage (Fixomull® Stretch (adhesive fleece) supplied by Beiersdorf AG
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, using warm water
- Time after start of exposure: 24h, right after removal of the dressing
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5ml/kg b.w.
- Concentration (if solution): 40%
- For solids, paste formed:no (suspension) - 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 exposure, once every workday thereafter
- Frequency of weighing: weekly, beginning on day 0
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, skin reactions according to Draize
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:
- no mortality occured
- Clinical signs:
- other: no systemic toxicity was observed, local skin irritation was observed in 1 male and all females (details on severity in tables 1+2)
- Gross pathology:
- no abnormalities
Any other information on results incl. tables
Table 1: Skin irritation males
| Animal No.: | R 40 | R 41 | R 42 | R 43 | R 44 |
| Erythema grade 1: | - | - | d7 - d10 | - | - |
| Erythema grade 2: | - | - | d2 - d6 | - | - |
| Incrustations: | - | - | d6 - d14 | - | - |
| Scaling: | - | - | d6 - d7 | - | - |
Table 2: Skin irritation females
| Animal No.: | R 45 | R 46 | R 47 | R 48 | R 49 |
| Erythema grade 1: | d1 - d6 | d6 - d7 | d8 - d14 | d6 - d7 | d3 - d6 |
| Erythema grade 2: | - | d1 - d3 | d1; d6 - d7 | d1 - d3 | d1 - d2 |
| Erythema grade 3: | - | - | d2 - d3 | - | - |
| Incrustations: | - | - | d6 - d14 | - | - |
| Scaling: | - | d6 - d8 | d6 - d14 | d6 - d8 | d6 - d7 |
d: day
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of this study the median lethal dose (LD50) of the test substance after single dermal application was found to be greater than 2000 mg/kg bw in male and female rats.
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