Disodium 4-[2-[(1-oxoundec-10-enyl)amino]ethyl] 2-sulphonatosuccinate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1964-10-24 to 1965-03-05

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was conducted non-GLP, however it was performed according to state of the art methods with an acceptable, well documented study report which meets basic scientific principles. It 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:

1965

Report date:

1965

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: Appraisal of the safety of chemicals in foods, drugs and cosmetics of the association of food and drug officials of the United States 1959

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

no necropsy data for survivors

GLP compliance:

no

Remarks:

study performance before implementation of GLP

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Disodium 4-[2-[(1-oxoundec-10-enyl)amino]ethyl] 2-sulphonatosuccinate

EC Number:

247-873-6

EC Name:

Disodium 4-[2-[(1-oxoundec-10-enyl)amino]ethyl] 2-sulphonatosuccinate

Cas Number:

26650-05-5

Molecular formula:

C17H29NO8S.2Na

IUPAC Name:

disodium 4-[2-[(1-oxoundec-10-enyl)amino]ethyl] 2-sulphonatosuccinate

Details on test material:

- Name of test material (as cited in study report): SBU 185 (50 % aqueous solution)
- Substance type: Sulfosuccinate (tensio-active)
- Physical state: Aqueous solution
- Analytical purity: Not provided
- Impurities (identity and concentrations): 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
- Other: the registered trade mark for SBU 185 in Germany is Steinazid SBU 185, in Great Britain: Loramine SBU 185

Test animals

Species:

rat

Strain:

other: Albino

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: young adults
- Weight at study initiation: no data
- Fasting period before study: overnight
- Housing: no data
- Diet (e.g. ad libitum): ad libitum, standardised laboratory died
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Doses:

1.99, 2.51, 6.31, 8.00 and 10.00 g/kg bw
The test material was applied in the original state (aqueous solution, 50 %), as delivered by the sponsor.

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

Healthy adult albino rats were fasted overnight prior to dosage. Groups of 10 rats each were balanced with respect to weight and sex distribution. Alldoses were given by stomach tube. After dosing, the rats were returned to their individual cages. Water and later feed cups containing their regular food was restored.
After preliminary range finding experiments the dose levels for SBU 185 are set as follows: 1.99 g/kg bw; 2.51 g/kg bw; 6.31 g/kg bw; 8.00 g/kg bw and 10.00 g/kg bw. It was impossible to give higher doses than 10 g/kg by stomach tube as the material had to be used in 50% solution and because in higher concentrations it is too viscous. The rats were observed frequently during the dosage days, mortality records being made at daily intervals for a period of two weeks. Records were kept of body weight and of any departure from normal health, behavior and appearance.

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Remarks:

as delivered by the sponsor

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 450 mg/kg bw

Based on:

other: Recalculated LD50 referring to solid content of the test material (according to producers information): 24.5 % in minimum

Mortality:

In the dose groups 1.99, 2.51, 6.31, 8.00 and 10.00 g/kg bw 10, 0, 0, 10 and 20 %, respectively. Animals were found death on the first or second day after application.

Clinical signs:

none

Body weight:

no dose related effects

Gross pathology:

no data

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

On the basis of the results obtained after a single oral administration, the oral LD50 of the test article SBU 185 (50%) was determined to be > 10000 mg/kg bw ; recalculated LD50 referring to solid content: > 2450 mg/kg bw in minimum. No significant clinical signs or effects on body weight were observed. Classification for acute oral toxicity Caregory V is justified for SBU 185 according to OECD GHS (2nd rev. edition, UN, 2007).

Executive summary:

In an acute oral toxicity study groups of fasted male and female young adult albino rats were given a single oral dose os SBU 185 (50%) at doses of 1990, 2510, 6310, 8000 and 10000 mg/kg bw and observed for 14 days.

In the dose groups 1990, 2510, 6310, 8000 and 10000 mg/kg bw 10, 0, 0 ,10 and 20% of animals died , respectively. Animals were found death on the first or second day after application. No clinical signs or effects on body weight were observed.

Oral LD₅₀ males/females >10000 mg/kg bw

The LD₅₀ determined refers to the test material as specified above (50%).

LD₅₀ (14 days) referring to solid content: > 2450 mg/kg bw in minimum.

Solid content of SBU 185 50% according to producers information: minimum 24.5%.