Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide

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:

2011

Report date:

2011

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

adopted Feb. 24th, 1987

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

May 30th, 2008

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Version / remarks:

August 1998

Test guideline 4

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

Test material information

Constituent 1

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

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.