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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April 2011

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

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:

TIB KAT 223 VP10-054

Test animals

Species:

rat

Strain:

other: Crl:CD(SD)

Sex:

male/female

Administration / exposure

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

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Any other information on results incl. tables

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.

Applicant's summary and conclusion

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.