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

Repeated dose toxicity: oral

Administrative data

Endpoint:

short-term repeated dose toxicity: oral

Remarks:

combined repeated dose and reproduction / developmental screening

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2010-2012

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: study according guideline, glp. Only draft report available, discrepance between study summarey and raw data. Study in reevaluation,; study not finaliesd

Data source

Reference

Reference Type:

other: Draft Report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)

Deviations:

yes

Remarks:

Additional dtermination of Sn in plasma

Principles of method if other than guideline:

Additional dtermination of Sn in plasma

GLP compliance:

yes

Limit test:

no

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

Test material form:

solid - liquid: suspension

Remarks:

migrated information: dispersion

Details on test material:

-

Test animals

Species:

rat

Strain:

other: Crl:CD(SD)

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Analytical verification of doses or concentrations:

yes

Duration of treatment / exposure:

6 weeks, additional group with 6 weeks and 2 weeks recovery

Frequency of treatment:

daily

Doses / concentrations

Doses / concentrations 1

Remarks:

Doses / Concentrations:
0 mg/kg bw/day
Basis:
actual ingested

Doses / concentrations 2

Remarks:

Doses / Concentrations:
4 mg/kg bw/day
Basis:
actual ingested

Doses / concentrations 3

Remarks:

Doses / Concentrations:
20 mg/kg bw/day
Basis:
actual ingested

Doses / concentrations 4

Remarks:

Doses / Concentrations:
50 mg/kg bw/day
Basis:
actual ingested

No. of animals per sex per dose:

10 male and female

Control animals:

yes, concurrent vehicle

Results and discussion

Effect levels

Dose descriptor:

LOEL

Effect level:

2.5 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: small thymus

Target system / organ toxicity

Critical effects observed:

not specified

Any other information on results incl. tables

no malformations found.

Problems in the lactation phase see overall remarks.

Applicant's summary and conclusion

Conclusions:

The LOEAL for maternal toxicty was determined to be 4 mg/kg bw /day, for unschuedled deads and decrease in bw at 20 mg/kg bw/day. There were no adverse effects belonging to reproduction according to the FDA guidelines.
Many litters in the dose groups found dead without milk in the stomach. The data from necropsy show no evidence for adverse effects relating to teats of the dams including no or a decreased milk volume, or the litters could not drink. An analysis of the milk was not performed in due it is not part of the guideline OECD 422. So it is not possible to bevaluate the study in the lactation periode