2-ethylhexyl 14-ethyl-6,6-dioctyl-4,8,11-trioxo-5,7,12-trioxa-6-stannaoctadeca-2,9-dienoate

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

Study period:

July 7th to August 4th, 1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Reliability of original study is 1

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:

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 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
- Source: CIBA-GEIGY Ltd. Tierfarm, 4334, Sisseln, Switzerland.
- Age at study initiation: 7 - 8 weeks.
- Weight at study initiation: 180 - 196 g.
- Diet: rat food (NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland)), ad libitum.
- Water: ad libitum.
- Fasting period before study: animals were fasted overnight before dosing.

ENVIRONMENTAL CONDITIONS
- Kept under conventional laboratory conditions.
- Air conditioned.
- Temperature: 22 ± 3 °C.
- Humidity: 55 ± 15 %.
- Air changes: approximately 15 per hour.
- Photoperiod: 12 hrs 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 bw

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).
Berkson J (1944) J. Am. Stat. Ass. 39: 357-65

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.

Clinical signs:

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

Body weight:

At the higher doses, bodyweight development was highly erratic during the first week following treatment, but normalised thereafter.

Gross pathology:

No treatment-related gross organ changes were observed.

Any other information on results incl. tables

Table: 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: 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: 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 as harmful/toxic according to the CLP Regulation (EC) No.1272/2008

Conclusions:

LD50: 3793 mg/kg (male/female rat)

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 were observed for 14 days.

Four male and four 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 curved body position. All survivors had recovered by the end of the observation period and no gross abnormalities were observed at necropsy.

LD50: 3793 mg/kg (male/female rat)