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

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study (OECD 401) with acceptable restrictions.

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:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dioctyltin bis(2-EHMA) [CAS No. 15571-58-1]: Octyltin tris(2-EHMA) [CAS No. 27107-89-7] (90:10% mixture)

IUPAC Name:

Dioctyltin bis(2-EHMA) [CAS No. 15571-58-1]: Octyltin tris(2-EHMA) [CAS No. 27107-89-7] (90:10% mixture)

Details on test material:

Dioctyltin bis(2-EHMA) [CAS No. 15571-58-1]: Octyltin tris(2-EHMA) [CAS No. 27107-89-7] (90:10% mixture)

Test animals

Species:

rat

Strain:

other: Tif:RAIf (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 190-215 g
- Fasting period before study: no (but before administration)
- Housing: in groups of 5
- Diet (e.g. ad libitum): not precised, ad libitum
- Water (e.g. ad libitum): not precised, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 10%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours 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:

Groups of rats were fasted overnight and administered a single oral dose of the test substance (dose volume = 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:

other: 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;

Gross pathology:

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

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category IV

Remarks:

Migrated information Criteria used for interpretation of results: other: Regulation EC No 1272/2008 (CLP)

Conclusions:

The acute oral toxicity rat LD50 was determined to be 2000 mg/kg bw for DOT(2-EHMA).

Executive summary:

An acute oral toxicity to rat study (OECD 401) was carried out with a mixture of DOT (2 -EHMA) and MOT(2 -EHMA) (90:10%) . Two doses were tested (single dose of 1000 and 2000 mg/kg bw/d) with a 14 -days observation period. Animals in both dose groups exhibited clinical signs of toxicity and effects on mortality were observed. The LD50 was lower for female rats, the overall LD50 was 2000 mg/kg bw .