Dioctyl phosphonate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From March 29th to April 20th, 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

February 24th, 1987

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dioctyl phosphonate

EC Number:

217-315-6

EC Name:

Dioctyl phosphonate

Cas Number:

1809-14-9

Molecular formula:

C16H35O3P

IUPAC Name:

dioctyl phosphonate

Test material form:

liquid

Test animals

Species:

rat

Strain:

other: Tif: RAI f (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CIBA-GEIGY Limited, Animal Production, 4332 Stein/Switzerland.
- Weight at study initiation: 201-258 g.
- Housing: individually in Macrolon cages type 3, with the standardized soft wood bedding.
- Diet: rat chow (NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland), ad libitum.
- Water: ad libitum.
- Acclimation period: 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C;
- Humidity: 55 ± 10 %;
- Air changes: 15 per hour;
- Photoperiod: 12 hour/day light cycle.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: back;
- % coverage: about 10 %.
- Pretreatment: shaving of the treated area with an electric clipper approximately 24 hours before treatment;
- Type of wrap if used: gauze-lined semiocclusive dressing fastened around the trunk with an adhesive elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: yes, with lukewarm water;
- Time after start of exposure: 24 hours.

TEST MATERIAL
- Amount applied: 2000 mg/kg bw (2 ml/kg bw);
- Vehicle: none, liquid substance used undiluted.

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

10 rats (5 males and 5 females)

Control animals:

not required

Details on study design:

- Frequency of application: one single dose.
- Duration of observation period following administration: 14 days for the females and 22 days for the males.
- Frequency of mortality observations: daily, a.m. and p.m. on working days, a.m. on weekend days.
- Frequency of signs and symptoms observations: daily.
- Necropsy of survivors performed: yes.
- Other examinations performed: Body weight: immediately before application and on days 7 and 14 (additionally on day 22 in case of the males).

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: In the females erythema, scaling and necrosis at the application site were observed; they recovered within 13 days. In the males edema at the application site was noticed until day 4, erythema and necrosis were observed until day 8, from day 9 until day 2

Gross pathology:

At autopsy, no deviations from normal organs morphology were found.

Applicant's summary and conclusion

Interpretation of results:

other: not classified for acute dermal toxicity according to the CLP Regulation (EC n.1272/2008).

Conclusions:

LD50 rat dermal route (males/females) > 2000 mg/kg bw and no classification for acute dermal toxicity is required according to the CLP Regulation (EC n.1272/2008).

Executive summary:

The substance was tested for acute dermal toxicity on rats according to OECD TG 402.

Upon an acute dermal administration and 14 to 22 day post-treatment observation period, the LD50 in rats of both sexes is greater than 2000 mg/kg bw.

Erythema, scaling and necrosis at the application site were observed. The females recovered within 13, the males within 9 days from necrosis. In the latters, scurf was seen until day 21.

At autopsy, no deviations from normal morphology were found.