Sodium 1,4-diisotridecyl sulphonatosuccinate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1968

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1968

Report date:

1968

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 1,4-diisotridecyl sulphonatosuccinate

EC Number:

259-515-6

EC Name:

Sodium 1,4-diisotridecyl sulphonatosuccinate

Cas Number:

55184-72-0

Molecular formula:

C30H58O7S.Na

IUPAC Name:

sodium 1,4-bis[(2-methyldodecyl)oxy]-1,4-dioxobutane-2-sulfonate

Test material form:

other: slightly viscous liquid

Details on test material:

- Name of test material (as cited in study report): Aerosol TR-70 sodium Bis-tridecyl Sulfosuccinate
(70% aqueous solution)
- Physical state: Not provided, but it is assumed that the test material is a slightly viscous liquid
- Analytical purity : 70%
- 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:

TEST ANIMALS
- Fasting period before study:24 hours

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Animals fasted for 24 hours were dosed with the product as received.

Doses:

10.0 mL/kg, 5.0 mL/kg, 2.5 mL/kg and 1.25 mL/kg
Taking into account a 70% active ingredient purity, dose levels correspond with 7000, 3500, 1750 and 875 mg act. ingr./kg bw.

No. of animals per sex per dose:

5 (male rats in 4 dose groups)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations: daily; Frequency of weighing: initially and terminally
- Necropsy of survivors performed: yes
- Other examinations performed: signs of intoxication, mean body weight

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

> 10 mL/kg bw

Based on:

test mat.

Remarks:

=70% aqueous solution

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

> 7 000 mg/kg bw

Based on:

act. ingr.

Mortality:

No

Clinical signs:

other: other: No

Gross pathology:

Normal

Any other information on results incl. tables

Table 1. Single oral dose, male albino rats (MR Wistar) LD₅₀> 10 ml/kg

Dosage Ml/kg	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										0/5	162	245
5.0										0/5	138	237
2.5										0/5	139	240
1.25										0/5	137	241

 Signs of intoxication: None observed

Gross autopsy: Normal

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The acute oral LD50 of the test item Butanedioic acid, sulfo-, 1,4-ditridecyl ester, sodium salt (70% active ingredient) in male rats was greater than 10 mL/kg bw or 7000 mg active ingredient/kg bw.
This test item is considered to be practically non-toxic by ingestion in single doses.

Executive summary:

Wistar rats fasted for 24 hours were dosed with Butanedioic acid, sulfo,- 1,4 -ditridecyl ester, sodium salt (70% active ingredient) at dosages of 10.0 mL/kg, 5.0 mL/kg, 2.5 mL/kg and 1.25 mL/kg. There were no mortalities. There were no signs of intoxication observed and gross autopsy was normal. The oral LD50 of the test item was greater than 10 mL/kg bw or 7000 mg active ingredient/kg bw.