2-ethylhexyl 12-ethyl-5,5-dioctyl-9-oxo-10-oxa-4,6-dithia-5-stannahexadecanoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

other: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Justification for type of information:

Justification for Read Across is given in Section 13 of IUCLID.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

2 doses were used but one dose only with males and females

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate

EC Number:

239-622-4

EC Name:

2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate

Cas Number:

15571-58-1

Molecular formula:

C36H72O4S2Sn

IUPAC Name:

2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecan-1-oate

Test animals

Species:

rat

Strain:

other: Tif:RAIf (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 190-215 g.
- Fasting period before study: rats fasted overnight.
- Housing: in groups of 5.
- Diet: ad libitum.
- Water: ad libitum.
- Acclimation period: at least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 55 ± 10 %.
- Photoperiod: 12 hrs light/day

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

other: 0.5 % (w/v) CMC in 0.1 % (w/v) polysorbate-80 (aq.)

Details on oral exposure:

DOSE VOLUME APPLIED: 10 ml/kg bw

Doses:

1000 and 2000 mg/kg bw

No. of animals per sex per dose:

1000 mg/kg bw: 5 males
2000 mg/kg bw: 5 males, 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days.
- Frequency of observations: once or twice daily for clinical signs of toxicity and mortality.
- Frequency of weighing: on days 1 (prior to dosing), 7, 14, or at death.
- Necropsy of survivors performed: yes. Animals that died were sacrificed and necropsied. Surviving animals were sacrificed and necropsied at the end of the exposure period.

Statistics:

Mortality data were evaluated and the LD50 (with lower 95 % confidence limit) was calculated by the logit model.

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 000 mg/kg bw

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

< 2 000 mg/kg bw

Effect levels 3

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

Mortality (number dead/total number exposed), by sex and concentration tested:
1000 mg/kg bw: 0/5 (males only)
2000 mg/kg bw: 1/5 male (died day 9), 4/5 females (died days 9, 10, 12, 13)

Clinical signs:

Animals in both dose groups exhibited clinical signs of toxicity that included slight to moderate piloerection, dyspnea, hunched posture, and reduced locomotor activity. A single male in the 2000 mg/kg bw dose group exhibited signs of ataxia and cyanosis; all 5 females in that group also showed signs of ataxia. Surviving animals recovered within 6-13 days.

Gross pathology:

No substance-related gross organ changes were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:

other: classified in Acute Toxicity Category 4 according to the CLP Regulation (EC) No.1272/2008.

Conclusions:

LD50 (rat) = 2000 mg/kg bw.

Executive summary:

The acute oral toxicity of the test material to rat was evaluated in the standard acute method according to the OECD Guideline 401. The substance was orally single administered to 5 males at 1000 mg/kg bw and to 5 male and 5 female rats at 2000 mg/kg bw. The rats were weighed on days 1 prior to dosing and then on day 7, 14 or at death. The rats were observed for 14 days for clinical signs of toxicity and mortality. Animals that died were sacrificed and necropsied. Surviving animals were sacrificed and necropsied at the end of the exposure period.

Animals in both dose groups exhibited clinical signs of toxicity and effects on mortality were observed.

LD50 < 2000 mg/kg bw (female rats)

LD50 > 2000 mg/kg bw (male rats)

overall LD50 was 2000 mg/kg bw