Dibenzo[d,f][1,3,2]dioxaphosphepin, 6,6'-[[3,3',5,5'-tetrakis(1,1-dimethylethyl)[1,1'-biphenyl]-2,2'-diyl]bis(oxy)]bis-

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline Study (OECD).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

24 February, 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

30 May 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 Guidelin of 12 Nousan No. 8147

GLP compliance:

yes (incl. QA statement)

Remarks:

Bioassay, Labor fuer biologische Analytik GmbH, Heidelberg, Germany

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Test material form:

solid - liquid: suspension

Details on test material:

- Name of test material (as cited in study report): L4-Ligand
- Physical state: white solid
- Analytical purity: 97.0g/100g ± 0.3g/100g
- Lot/batch No.: 0005473663
- Expiration date of the lot/batch: 01 February, 2013
- Storage condition of test material: room temperature, under N2, protected from humidity
- Other: test substance is homogeneous by visual inspection

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, Sulzfeld, Germany
- Age at study initiation: male - approximately 8 weeks, female - approximately 12 weeks
- Weight at study initiation: mean (male): 240.6g ± 6.69g, (female): 203.6g ± 6.27g
- Housing: single housing in Makrolon Type III cages
- Diet: VRF1 (P); SDS Special Diets Services, Altrip, Germany
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C
- Humidity (%): 30 - 70%
- Air changes (per hr): approximately 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

olive oil

Details on dermal exposure:

TEST SITE
- Area of exposure: 40 cm²
- % coverage: at least 10% of body surface
- Type of wrap if used: air-permeable dressing (4 layers of absorbent gauze) and stretch bandage (Fixomull stretch, adhesive fleece)

REMOVAL OF TEST SUBSTANCE
- Washing: warm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied: 3.33 mL/kg bw
- Concentration: 0.6g/mL
- Constant volume or concentration used: yes
- For solids, paste formed: no, suspension used

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations for clinical signs several times on day of application and once daily hereafter on working days, body weights were determined before application and on day 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, skin findings (scoring was done 30-60 minutes after removal of the dressing and weekly thereafter)

Statistics:

Calculations were performed using Microsoft Excel 2003 and checked with a calculator.

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 mortalities observed

Mortality:

No mortalities occured.

Clinical signs:

other: No clinical signs or local effects were observed during the study.

Gross pathology:

No macroscopic pathologic abnormalities were noted in the animals (5 males and 5 females) examined on the last day of observation.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

DSD: not classified
CLP: not classified