Reaction mass of sodium (methylbutyl and pentyl) sulfonate and sodium 1,2-bis(pentyloxycarbonyl)ethanesulphonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1957

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study non-GLP with limited data on study design, however the study was conducted to state of the art methods at that time period. The study is therefore considered adequate, reliable and relevant.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1957

Report date:

1957

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

7 days observation period

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

trisodium 1,4-dioxo-1,4-bis(pentyloxy)butane-2-sulfonate pentane-1-sulfonate pentane-2-sulfonate

EC Number:

941-224-7

Molecular formula:

C14H25O7S.Na

IUPAC Name:

trisodium 1,4-dioxo-1,4-bis(pentyloxy)butane-2-sulfonate pentane-1-sulfonate pentane-2-sulfonate

Test material form:

other: waxy solid

Details on test material:

- Name of test material (as cited in study report): Aerosol AY; sodium diamylsulfosuccinate
- Physical state: White, waxy solid
- Analytical purity: >97%
- Impurities (identity and concentrations): See confidential details
- Composition of test material, percentage of components: See confidential details
- Isomers composition: Not provided
- Purity test date: Not provided
- Lot/batch No.: SPS 900A-MH
- Expiration date of the lot/batch: Not provided
- Stability under test conditions: Good stability in aqueous solution
- Storage condition of test material: Not provided

Test animals

Species:

rat

Strain:

other: albino

Sex:

male

Details on test animals or test system and environmental conditions:

Not provided

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

water

Remarks:

20% aqueous solution

Doses:

10.0 g/kg, 5.0 g/kg, 2.5 g/kg, 1.25 g/kg

No. of animals per sex per dose:

5 males per dose

Control animals:

no

Details on study design:

The product (Aerosol AY) was administered to groups of young, male albino rats (5 animals per group) as an 20% aqueous solution at dosages ranging from 1.25 g/kg to 10 g/kg.

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

ca. 4 650 mg/kg bw

Based on:

act. ingr.

95% CL:

> 3 000 - < 7 250

Mortality:

Death occurred fairly promptly following lethal doses, usually within one-half to one hour.
From the number and distribution of deaths, the LD50 of the product is calculated as 4650 (3000-7250) mg/kg bw.

Clinical signs:

other: Survivors exhibited varying degrees of depression for periods up to 24 hours following the dose, but thereafter maintained a normal appearance and behavior for remainder of a 7-day observation period.

Gross pathology:

They were sacrificed at the end of this time, and gross autopsy disclosed no pathology that could be attributed to the dose.

Any other information on results incl. tables

Table 1: Aerosol AY: Single Dose to Male Albino Rats by Mouth. Product Administered as a Solution in Water, 1 mL= 0.2 g.

 

Animal Number	Body weight in Grams	Weight Change in 7 Days	Dosage in g/kg	Dose in Grams	Dose in mL of Solution	Days to Death
R 9956	93	-	10.0	0.94	4.7	<1
R 9957	107	-	10.0	1.08	5.4	<1
R 9958	111	-	10.0	1.12	5.6	<1
R 9959	110	-	10.0	1.10	5.5	<1
R 9960	102	-	10.0	1.02	5.1	<1
R 9961	110	-	5.0	0.55	2.75	<1
R 9962	106	-	5.0	0.53	2.65	<1
R 9965	105	20	5.0	0.53	2.63	S
R 9966	98	28	5.0	0.49	2.45	S
R 9967	102	34	5.0	0.51	2.55	S
R 9968	103	-	2.5	0.26	1.29	<1
R 9969	104	34	2.5	0.26	1.30	S
R 9970	106	20	2.5	0.27	1.33	S
R 9971	98	37	2.5	0.25	1.23	S
R 9972	114	49	2.5	0.29	1.43	S
R 9877	90	28	1.25	0.11	0.57	S
R 9880	92	30	1.25	0.12	0.58	S
R 9881	93	35	1.25	0.12	0.59	S
R 9884	90	26	1.25	0.11	0.57	S
R 9890	94	2	1.25	0.12	0.59	S

S= Survived

LD₅₀= 4.65 (3.00-7.25) g/kg

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral LD50 of Aerosol AY dosed as a 20% aqueous solution to male albino rats is 4.65 (3.00-7.25) g/kg .

Executive summary:

The test item was administered to groups of young, male albino rats (5 animals per group) as an 20% aqueous solution at dosages ranging from 1.25 g/kg to 10 g active ingredient/kg bw. Death occurred fairly promptly following lethal doses, usually within one-half to one hour, and post-mortem examination revealed moderate to severe hemorrhage of the entire gastrointestinal tract. From the number and distribution of deaths, the LD₅₀ of the product is calculated as 4.65 (3.00-7.25) g/kg. Survivors exhibited varying degrees of depression for periods up to 24 hours following the dose, but thereafter maintained a normal appearance and behavior for remainder of a 7-day observation period. They were sacrificed at the end of this time, and gross autopsy disclosed no pathology that could be attributed to the dose.