Tin, dioctylbis(2,4-pentanedionato-.kappa.O2,.kappa.O4)-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2008

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD nø 423 (24 April 2002) Test method B.1tris directive 2004/73/EC

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Groupe Interminsteriel Des Produits Chimiques, Paris, France

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

483-270-6

EC Name:

-

Cas Number:

54068-28-9

Molecular formula:

Hill formula: C26H48O4Sn CAS formula: C26H48O4Sn

IUPAC Name:

(3Z)-4-{[dioctyl({[(2Z)-4-oxopent-2-en-2-yl]oxy})stannyl]oxy}pent-3-en-2-one

Details on test material:

VP07-560

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: no vehicle

Doses:

Control: 2 ml/kg bw distilled water
Treated: 1,79 ml/kg bw TIB KAT 223 ( = 2000 mg/kg bw)

No. of animals per sex per dose:

Control: 6
Treated: 6

Control animals:

yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 500 mg/kg bw

Mortality:

Female: CA 2000 mg/kg bw; Number of animals: 3; Number of deaths: 1
Female: CA 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0

Clinical signs:

other: Signs of toxicity related to dose levels: It was registered in the treated animals, from 30 minutes after the test item administration, a decrease of the spontaneous activity (6/6) associated with an absence of Preyer's reflex (5/6), a bradypnea (6/

Gross pathology:

Effects on organs:
The macroscopical examination of the animal which died
during the study revealed the presence of

black spots at the level of the corpus.

The macroscopical examination of the animals at the end of
the study did not reveal treatment-related

changes.

Any other information on results incl. tables

It was noted the dead of one of treated rat, 48 hours after the test item adnministration.

It was registered in the treated aninmals, from 30 miniutes after the test item administration, a decrease of spontanous acitvity (6/6) assoziated with an absence of Preyer´s reflex (5/6), a bradypneu (6/6), a decrease of muscle tone (5/6), the eyes partly closed (5/6), an increase of lachrymation (3/6), a decrease or an absence of righting reflex (5/6), tremors (2/6) an a piloerection (6/6). The animals recovered a normal activity between the 2nd day and the 3rd day of the test.

A deacrease of the body weight gain was noted in all treated animals, 48 hours after the test item administration. Then the body weight evolution of the animals remsined normal similar between treated and the controll animals.

The macroscopical examination of the animal which died during the study revealed the presend of black spots at the level of the corpus.

The macroscopical examination of the animals of the end of the study did not reveal tredment-related changes.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In conclusion, the LD_{50} of the test item TIB KAT 223 is 2500 mg/kg bw in the oral route in the rat.
-> EEC/67/548: no classification, no symbol and risk phrase
-> 1272/2008/EC: must not be classified in Cat.4, no signal word and hazard statement are required.
Remark: Classification in the UN GHS System is Cat.5