Ethyl 9,9-dioctyl-4,7,11-trioxo-3,8,10-trioxa-9-stannatetradeca-5,12-dien-14-oate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07 July 1982 to 04 August 1982

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Ethyl 9,9-dioctyl-4,7,11-trioxo-3,8,10-trioxa-9-stannatetradeca-5,12-dien-14-oate

EC Number:

268-500-3

EC Name:

Ethyl 9,9-dioctyl-4,7,11-trioxo-3,8,10-trioxa-9-stannatetradeca-5,12-dien-14-oate

Cas Number:

68109-88-6

Molecular formula:

C28H48O8Sn

IUPAC Name:

ethyl 9,9-dioctyl-4,7,11-trioxo-3,8,10-trioxa-9-stannatetradeca-5,12-dien-14-oate

Test material form:

other: liquid that tends to crystallise

Details on test material:

- Appearance: clear liquid, tends to crystallise

Test animals

Species:

rat

Strain:

other: Tif:RAIF(SPF), F3-crosses of RII 1/Tif x RII2/Tif

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 7 - 8 weeks
- Weight at study initiation: 180 - 196 g
- Housing: Groups of 5, in cages with standardised soft wood bedding
- Diet (e.g. ad libitum): Rat food, ad libitum
- Water (e.g. ad libitum): ad libitum
- Fasting period before study: Animals were fasted overnight before dosing.

ENVIRONMENTAL CONDITIONS
- Kept under conventional laboratory conditions.
- Air conditioned.
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 15 %
- Air changes (per hr): Approximately 15 per hour
- Photoperiod (hrs dark / hrs light): 12 hours light/dark

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Distilled water containing 0.5 % carboxymethylcellulose and 0.1 % polysorbate 80

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bodyweight

Doses:

1000, 2500 and 5000 mg/kg

No. of animals per sex per dose:

5 males and 5 females per dose

Control animals:

no

Details on study design:

OBSERVATIONS
- Period: 14 days or until all symptoms have disappeared.
- Mortality: daily am and pm on working days.
- Clinical Signs: daily.
- Bodyweight: on days 1, 7, 14 and at death.
- Necropsies: spontaneously dying animals were subjected to gross necropsy as soon as possible and survivors at the termination of the study.

Statistics:

- Bodyweights: Group means and standard deviations were calculated.
- The LD50 including the 95 % confidence limit was calculated by the logit method (Berkson, 1944).

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

3 793 mg/kg bw

Based on:

test mat.

95% CL:

2 648 - 6 646

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

3 821 mg/kg bw

Based on:

test mat.

95% CL:

2 178 - 25 811

Effect levels 3

Sex:

female

Dose descriptor:

LD50

Effect level:

3 821 mg/kg bw

Based on:

test mat.

95% CL:

2 178 - 25 811

Mortality:

4 males and 4 females died at the 5000 mg/kg dose level. All deaths occurred within 5 days post exposure. See Table 1 for details.

Clinical signs:

other: The following clinical signs were observed: sedation, dyspnoea, exophthalmus, ruffled fur and curved body position. Surviving animals recovered within 14 days. See Table 2 for details.

Gross pathology:

No treatment-related gross organ changes were observed.

Any other information on results incl. tables

Table 1 Mortality Data

Dose (mg/kg)	Totals			Time of Death
	In the Group	Deaths		Hours After Treatment				Days After Treatment
		Number	%	1	3	5	24	2	3	4	5
Males
1000	5	0
2500	5	0
5000	5	4	80						1	1	2
Females
1000	5	0
2500	5	0
5000	5	4	80				1		2	1

Table 2 Clinical Signs

Observations

Hours After Treatment

Days After Treatment

1

3

5

24

2

3

4

5

6

7

8

9

10

11

12

13

1000 mg/kg

Sedation

X

X

Dyspnoea

XX

XX

XX

XX

X

X

X

X

X

X

X

X

X

X

X

Exophthalmus

X

X

X

X

X

X

X

X

Ruffled fur

XX

XX

XX

XX

XX

XX

XX

XX

XX

XX

XX

X

X

X

X

X

Curved body

X

X

X

X

X

X

X

X

X

X

2500 mg/kg

Sedation

X

X

X

Dyspnoea

XX

XX

XX

XX

X

X

X

X

X

X

X

X

X

X

X

Exophthalmus

X

X

X

X

X

X

X

X

X

Ruffled fur

XX

XX

XX

XX

XX

XX

XX

XX

XX

XX

XX

X

X

X

X

X

Curved body

X

X

X

X

X

X

X

X

X

X

5000 mg/kg

Sedation

X

XX

XX

XX

XX

XX

XX

X

X

Dyspnoea

XX

XX

XX

XX

XX

XX

XX

X

X

X

X

X

X

X

X

Exophthalmus

X

X

X

X

X

X

X

Ruffled fur

XX

XX

XX

XX

XX

XX

XX

XX

XX

XX

XX

XX

XX

XX

XX

X

Curved body

X

X

X

X

X

X

X

X

X

X

X

X

X

X

 

Table 3 Bodyweights (g)

Dose (mg/kg)	Males			Females
	Day 1	Day 7	Day 14	Day 1	Day 7	Day 14
1000	183 (4.1)	237 (6.3)	272 (6.0)	184 (3.0)	211 (7.1)	226 (12.6)
2500	185 (5.0)	199 (18.9)	246 (7.9)	188 (5.4)	196 (24.3)	222 (11.1)
5000	185 (6.5)	-	-	184 (4.1)	-	-

( ) = Standard deviation

Applicant's summary and conclusion

Interpretation of results:

other: Not classified according to EU criteria.

Conclusions:

The LD50 of the test material was determined to be 3793 mg/kg in the male and female rat. The test material requires no classification in accordance with EU criteria.

Executive summary:

The acute oral toxicity of the test material was evaluated in a study conducted in accordance with the standardised guideline OECD 401.

Albino rats were administered a single oral dose of the test material by gavage at dose levels of 1000, 2500 and 5000 mg/kg bodyweight. Five animals per sex were dosed at each concentration and the animals observed for 14 days.

Four male and 4 female animals died within 5 days at the 5000 mg/kg bodyweight dose level. No further mortality was seen. Clinical signs included sedation, dyspnoea, exophthalmus, ruffled fur and exhibiting a curved body position. All survivors had recovered by the end of the observation period and no gross abnormalities were observed at necropsy.

Under the conditions of this study, the LD50 was determined to be 3793 mg/kg bodyweight and the test material requires no classification in accordance with EU criteria.