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Toxicological information

Acute Toxicity: oral

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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:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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 levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
> 10 mL/kg bw
Based on:
test mat.
Remarks:
=70% aqueous solution
Sex:
male
Dose descriptor:
LD50
Effect level:
> 7 000 mg/kg bw
Based on:
act. ingr.
Mortality:
No
Clinical signs:
No
Body weight:
See Table 1
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.