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

Acute Toxicity: other routes

Administrative data

Endpoint:

acute toxicity: other routes

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1961

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study was conducted non-GLP, however there was an acceptable documented study report which meets basic scientific principles. It is therefore considered to be relable. As the subcutaneous route is less relevant, the study is also not adequate for classification.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1961

Report date:

1961

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: OECD 401

Deviations:

yes

Remarks:

subcutaenous route; observation 24 hours.

Principles of method if other than guideline:

Single s.c. application to mice and calculation of 24 hour LD50
Study performance before implementation of corresponding international guidelines

GLP compliance:

no

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
-Substance type: Sulfosuccinate (tensio-active)
- Analytical purity: At least 49%

Test animals

Species:

mouse

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

no further data

Administration / exposure

Route of administration:

subcutaneous

Vehicle:

water

Doses:

0.02, 0.2, 1.0, 2.0, 4.0 and 8.0 g/kg bw

No. of animals per sex per dose:

3 to 10

Control animals:

no

Details on study design:

3, 4, 5, 10, 10 and 5 mice were subcutaneously dosed with 0.02, 0.2, 1.0, 2.0, 4.0 and 8.0 g/kg bw , respectively.
- Duration of observation period following administration: 24 hours
- Necropsy of survivors performed: no

Results and discussion

Effect levels

Effect levels 1

Sex:

not specified

Dose descriptor:

LD50

Effect level:

ca. 3 300 mg/kg bw

Based on:

test mat.

Remarks:

as delivered by the sponsor

Remarks on result:

other: Observation period: 24 hours

Effect levels 2

Sex:

not specified

Dose descriptor:

LD50

Effect level:

ca. 1 617 mg/kg bw

Based on:

other: Recalculated LD50 referring to solid content of the test material (according to producers information): 49 % in minimum

Mortality:

Up to and including a dose of 1000 mg/kg bw all animals survived. In the dose groups of 2000, 4000 and 8000 mg/kg bw 3/10, 6/10 and 5/5 animals died, respectively. (See Table 1)

Clinical signs:

no data

Body weight:

no data

Gross pathology:

no data

Any other information on results incl. tables

Table 1. Mortality after single subcutaneous dose

Dose (mg/mouse)	Dose (mg/kg bw)	Number of dosed animals	Mortality (%)
0.4	20	3	0
4.0	200	4	0
20.0	1000	5	0
40.0	2000	10	30
80.0	4000	10	60
160.0	8000	5	100

LD₅₀ as reported by the study authors: approximately 3300 mg/kg bw.

Applicant's summary and conclusion

Conclusions:

The subcutane LD50 of SBU-185 was > 1617 mg act.ingr./kg bw.

Executive summary:

In an acute toxicity study groups of mice were given a single subcutaneous dose of SBU-185 (at least 49% act. ingr.) at doses of  20, 200, 1000, 2000, 4000 and 8000 g/kg bw of the test material and observed for 24 hours.

Up to and including a dose of 1000 mg/kg bw all animals survived. In the dose groups of 2000, 4000 and 8000 mg/kg bw 3/10, 6/10 and 5/5 animals died, respectively.

 Subcutaneous LD₅₀ : approximately 3300 mg/kg bw.

LD50 value determined refers to the test substance as delivered by the sponsor.

Subcutaneous LD₅₀ : approximately 1617 mg/kg bw in minimum (referring to solid content).

Solid content of test item according to producers information: 49 % in minimum.