Sodium 1,2-diisobutoxycarbonylethanesulphonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1969

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study is performed in male animals only, with a +-45% active ingredient formulation, and not under GLP compliance. The study is conducted similar to OECD standard and shows consistent results, therefore the study is considered to be adequate, reliable and relevant.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1969

Report date:

1969

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

No. animals

Principles of method if other than guideline:

Only male rats were used.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 1,2-diisobutoxycarbonylethanesulphonate

EC Number:

204-839-5

EC Name:

Sodium 1,2-diisobutoxycarbonylethanesulphonate

Cas Number:

127-39-9

Molecular formula:

C12H22O7S.Na

IUPAC Name:

sodium 1,4-diisobutoxy-1,4-dioxobutane-2-sulfonate

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): AEROSOL® IB, Sodium di-iso-butyl sulfosuccinate
- Physical state: Not provided
- Analytical purity: 44-46 %
- Impurities (identity and concentrations): See confidential details
- Composition of test material, percentage of components: See confidential details
- Purity test date: Not provided
- Lot/batch No.: Not provided
- Expiration date of the lot/batch: Not provided
- Stability under test conditions: Not provided
- Storage condition of test material: Not provided

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

Not provided

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20% w/v

Doses:

10.0g/kg, 5.0 g/kg and 2.5 g/kg

No. of animals per sex per dose:

5 male rats per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Body weight: initial & terminal

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

6 160 mg/kg bw

Based on:

test mat.

95% CL:

4 660 - 8 120

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

2 772 mg/kg bw

Based on:

act. ingr.

95% CL:

2 097 - 3 654

Mortality:

5/5 in the 10.0 g/kg group
1/5 in the 5.0 g/kg group
0/5 in the 2.5 g/kg group

Clinical signs:

other: Motor ataxia, dyspnea, comatose, and death within 1 hour at 10 g/kg

Gross pathology:

Decedents: mucosa of stomach and intestines extremely hyperemic
Survivors: normal

Any other information on results incl. tables

Table 1. Body weights & clinical signs

Dosage	Onset of (S) Signs, (D) Death, Hours and Days									Died/Dosed	MEAN WT		Time of (R) Recovery, Days
	0-6	6-24	2	3	4	5	6	7	8-14		I	T	1	2	3	4	5	6	7-14
10.0 g/kg	SD5									5/5	103	-
5.0 g/kg					D1					1/5	106	221
2.5 g/kg										0/5	105	219

 I: initial; T: terminal

 

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

A mortality of 5/5 at a dosage of 20g/kg was assumed for calculation of the rat oral LD50.
The rat oral LD50 is calculated to be 6160mg/kg, corresponding to 2772 mg act.ingr./kg.

Executive summary:

Oral acute toxicity was tested in 5 male albino Wistar rats/group with a test item containing 44 -46% active ingredient at 10, 5 and 2.5 g/kg bw (4500; 2250 and 1125 mg act.ingr./kg bw). In the high dose group all 5 animals died within 6 hours after dosing. In the mid dose group 1 of 5 animals died on day 4; in the low dose group all animals survived. Clinical neurological signs were observed at the highest dose only and gross autopsy showed extremely hyperemic mucosa of stomach and intestines in the decedents, whereas survivors were normal. The LD₅₀ was calculated to be 6160 mg/kg, corresponding to 2772 mg act.ingr./kg