6H-dibenz[c,e][1,2]oxaphosphorin 6-oxide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November 16 2012 - January 4 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Modern, guideline, GLP study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

control animal included

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

HCA

IUPAC Name:

HCA

Constituent 2

Reference substance name:

6H-dibenz [c,e] [1,2] oxaphosphorin-6-oxide

IUPAC Name:

6H-dibenz [c,e] [1,2] oxaphosphorin-6-oxide

Constituent 3

Reference substance name:

6H-dibenz[c,e][1,2]oxaphosphorin 6-oxide

EC Number:

252-813-7

EC Name:

6H-dibenz[c,e][1,2]oxaphosphorin 6-oxide

Cas Number:

35948-25-5

Molecular formula:

C12H9O2P

IUPAC Name:

6H-dibenz[c,e][1,2]oxaphosphorin 6-oxide

Test material form:

solid: flakes

Details on test material:

- Name of test material (as cited in study report): HCA
- Physical state: white flake
- Analytical purity: 99.5%
- Purity test date: 2 August 2012
- Lot/batch No.: #220710
- Expiration date of the lot/batch: 10 July 2014
- Storage condition of test material: cool, dry, well-ventilated location

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Animal breeding facility, JRF
- Age at study initiation: 8 to 14 weeks
- Weight at study initiation: males 268-300; females 203-221
- Fasting period before study: no
- Housing: individually in polypropylene cages with stainless steel grid tops.
- Diet: Teklad Certified Global High Fiber Rat/Mice Feed manufactured by Harlan, USA ad libitum
- Water: UV sterilised and reverse osmosis filtered water ad libitum
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23
- Humidity (%): 65-66
- Air changes (per hr): min 15
- Photoperiod: 12 hrs dark /12 hrs light (light 06:00 - 18:00)

IN-LIFE DATES: From: 19 Nov 2012 To: 11 Dec 2012

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Remarks:

moistened with water

Details on dermal exposure:

TEST SITE
- Area of exposure: dorso lumbar area of trunk
- % coverage: ~ 10
- Type of wrap if used: porous gauze dressing (not more than 8-ply) and a non-irritating tape (Medi tape 330 hypo-allergenic surgical tape)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): cotton wool soaked in distilled water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 406-600 mg (2000 mg/kg)
- For solids, paste formed: pulverised and moistened with 0.2 mL distilled water

Duration of exposure:

24 hours

Doses:

single

No. of animals per sex per dose:

5

Control animals:

yes, concurrent vehicle

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at least twice per day for morbidity and mortality. Clinical signs once daily, body weights on day 0, 7 and 14.
- Necropsy of survivors performed: yes

Statistics:

body weight was statistically analysed by Student's "t" test.

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, no signs of systemic toxicity and no abnormalities at necropsy at only dose tested

Mortality:

There were no mortalities

Clinical signs:

No signs of toxicity were observed

Body weight:

Mean body weight of treated group was comparable to controls

Gross pathology:

There were no lesions of pathological significance

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

In an OECD guideline acute dermal toxicity study using groups of 5 males and 5 females the acute dermal median lethal dose of HCA was > 2000 mg/kg.

Executive summary:

Two groups of 5 male and 5 female rats were clipped and 0.2mL of distilled water or 2000 mg/kg HCA applied to an area of skin equal to approximately 10% of the body surface. The test site was covered with a semi-occlusive dressing for 24 hours, when it was removed and test site washed with distilled water. The animals were observed daily for signs of systemic toxicity and weighed at intervals during a 14 day observation period. At the end of the study the animals were killed and examined post mortem.

There were no mortalities, no signs of systemic toxicity, no treatment related effects on body weight and no abnomalities at necropsy.

The acute dermal median lethal dose of HCA was > 2000 mg/kg.