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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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
February 24th, 1987
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes
Limit test:
yes

Test material

Constituent 1
Chemical structure
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.