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

Endpoint summary

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2008

Reliability:

1 (reliable without restriction)

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

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

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

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.

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.

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

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

2 500 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April 2011

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: Crl:CD(SD)

Sex:

male/female

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Duration of exposure:

24 h

Doses:

1.9 mL/kg of the TIB KAT 223 liquid corresponds to 2000 mg/kg.

No. of animals per sex per dose:

limit test with 2000 mg/kg bw, 5 male, 5 female

Control animals:

no

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortalityand clinical signs

There were no deaths in this study. There were no test substance-related clinical sings.

Body weight

Individually body weight loss occurred in all males at 2000 mg/kg ranging from -28 g to -9 g from Day 1 to Day 4.

Females at 2000 mg/kg did not gain body weight between Day 1 and Day 4: Individual body weight changes in that time frame ranged from -2 g to +2 g. According empirical and pretest data for rats at this age in general body weight gains had to be expected (female pre-test values: 0 to +11g body weight gain). 

From Day 4 onwards the body weight development normalized for male and female rats and individually body weight gains was comparable to pretest values

Food consumption

Food consumption was reduced at 2000 mg/kg by -23% to -24% in males and -15% to -19% in females compared to pretest values.

From Day 4 onwards the food consumption normalized for male and female ratsand ranged in the range of pretest values and beyond that.

The impaired body weight development/body weight loss and food consumption in the first week of the study is considered to be test compound-related.

Macroscopic observations

The animals euthanized and necropsied at the end of the observation period showed no macroscopically visible organ changes.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The median lethal dermal dose value (LD50) of TIB KAT 223 in rats is greater than 2000 mg/kg body weight in this study

Executive summary:

Acute dermal toxicity testing of TIB KAT 223 in the rat yielded a median lethal dose (LD₅₀) above 2000 mg/kg body weight in both male and female animals.

There were no deaths and no test article-related clinical signs observed in this study.

The skin of the rats showed no test article-related signs of irritation.

Body weight loss occurred in all males from Day 1 to Day 4 treated with TIB KAT 223. Females showed reduced body weight gain within this time frame. From Day 4 onwards the body weight development normalized for both male and female rats and body weight gains were comparable to pretest values.

Food consumption was reduced in males and females, respectively, from Day 1 to Day 4; thereafter, food consumption was normalized andranged in the range of pretest values and beyond that.

The animals euthanized and necropsied at the end of the observation period showed no macroscopically visible organ changes.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed