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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

Constituent 1
Chemical structure
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 levelsopen allclose all
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
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.

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