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Administrative data

Description of key information

Oral acute toxicity was tested according to OECD 401 method in rats and mice,  leading to a LD50 of 
>7000 mg act.ingr./kg bw. Dermal acute toxicity was tested according to OECD 402 method in male
rabbits, demonstrating a LD50 of >3500 mg act.ingr./kg bw. Acute inhalation toxicity was waived based
upon the fact that acute inhalation exposure as such is very unlikely for sulfosuccinates due to their
substance properties.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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.
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Fasting period before study:24 hours


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
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

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

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
3 500 mg/kg bw
Quality of whole database:
Klimisch 2

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
other justification
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
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.
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rabbit
Strain:
other: albino
Sex:
male
Details on test animals and environmental conditions:
Not provided
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Not provided
- % coverage: Not provided
- Type of wrap if used: an impervious cuff

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not provided
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5.0 ml/kg and 2.5 ml/kg
- Concentration (if solution): 70% active ingredient
Duration of exposure:
24 hours
Doses:
5.0 mL/kg and 2.5 mL/kg corresponding with 3500 and 1750 mg active ingredient/kg bw.
No. of animals per sex per dose:
5 males per dose, 2 dosages
Control animals:
no
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 mL/kg bw
Based on:
test mat.
Remarks:
=70% aqueous solution
Sex:
male
Dose descriptor:
LD50
Effect level:
> 3 500 mg/kg bw
Based on:
act. ingr.
Mortality:
No
Clinical signs:
Diarrhea in 2 animals of the 5.0 mL/kg dose group 6-24 hours after application. The animals recovered day 2 after application.
Mild to moderate erythema. Product formed waxy film where applied.
Body weight:
See table 1
Gross pathology:
Normal

Table1. Single dermal dose, male albino rabbits, LD50> 5mL/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

5.0

 

S

 

 

 

 

 

 

 

0/5

3.03

3.14

 

R

 

 

 

 

 

2.5

 

 

 

 

 

 

 

 

 

0/5

3.32

3.38

 

 

 

 

 

 

 

LD50 Greater than 5 mL/kg

Signs of Intoxication: Diarrhea in 2 animals.

Skin irritation: Mild to moderate erythema. Product formed waxy film where applied.

Gross autopsy: Normal.

Interpretation of results:
not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The acute dermal LD50 of the test item, Butanedioic acid, 1,4-ditridecyl ester, sodium salt ( 70% active ingredient) in male rabbits was > 5 mL/kg bw, corresponding to > 3500 mg active ingredient/kg bw. The test item is considered to be practically non-toxic by single skin applications.
Executive summary:

2 Groups of 5 male albino rabbits underwent a covered application in continuous 24-hour contact with the shaved skin with the test item Butanedioic acid, sulfo-, 1,4 -ditridecyl ester, sodium salt (70% active ingredient) at dosages of 5.0 mL/kg and 2.5 mL/kg, corresponding to 3500 and 1750 mg active ingredient/kg bw. There were no mortalities. There were 2 animals with diarrhea but gross autopsy was normal. The oral LD50 of the test item was > 5 mL/kg bw or > 3500 mg active ingredient/kg bw. This test item is considered to be practically non-toxic by single skin applications.

 

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
3 500 mg/kg bw
Quality of whole database:
Klimisch 2

Additional information

Acute oral toxicity

- A key study for acute oral toxicity was performed wiht the registered substance in male and female Wistar rats with a test item containing 70% active ingredient at 10, 5, 2.5 and 1.25 mL/kg bw, corresponding to 7000, 3500, 1750 and 875 mg act.ingr./kg bw (American Cyanamid Company, 1968a). There were no mortalities. There were no signs of intoxication observed and gross autopsy was normal. The oral LD50 was >10 mL/kg bw or >7000 mg act.ingr./kg bw.

- Support studies were further available in rats and mice:

a. A test item containing 10% aqueous solution or dispersion in male albino rats dosed at 5 g test item/kg bw and followed for 7 days showed an LD50 > 3500 mg act. ingr./kg bw (Levinskas and Shaffer, 1961).

b. A test item administered as a 50% dispersion in oil in male mice dosed at 15, 17.5, 20 and 25 g test item/kg bw corresponding with 10500, 12250, 14000 and 17500 mg act. ingr./kg and followed for 10 days showed an LD50 of 14525 mg act. ingr./kg bw (Hazleton, 1950).

c.A test item administered as a 50% dispersion in oil in male mice dosed at 10.5, 15, 20 and 25 g test item/kg bw corresponding with 7000, 10500, 14000 and 17500 mg act. ingr./kg and followed for 7 days showed an LD50 of 11200 mg act. ingr./kg bw (Hazleton, 1951a).

- In conclusion, there was no acute oral toxicity hazard as the LD50 was consistently >2000 mg/kg bw. The LD50 >3500 mg/kg bw of the key study was selected as the most conservative value.

 

Acute dermal toxicity

- A key study for acute dermal toxicity (American Cyanamid Company, 1968b) was performed in male albino rabbits with the registered test substance containing 70% active ingredient at 5 and 2.5 mL/kg bw, corresponding to 3500 and 1750 mg act.ingr./kg bw. There were no mortalities. There were 2 animals with diarrhea but gross autopsy was normal. The LD50 was >5 mL test item/kg bw or >3500 mg act.ingr./kg bw.

- Further, there was a disregarded study with a test item administered as 1 cc test item/kg bw corresponding with 500 mg test item/kg bw or 350 mg act. ingr./kg bw and followed for 11 days (Hazleton, 1951b). As the volume was too low, the study was not considered adequate and relevant. Further, one animal died during the study, however relation to test item was not expected in comparison with other study, therefore the study was not considered to be reliable.

 

Acute inhalation toxicity

Intoxication due to acute inhalation exposure of industrial workers or even the acute inhalation exposure as such is very unlikely for sulfosuccinates due to large particle size, low vapour pressure and high hydrophilic properties of the substance.  Based on these and other physicochemical properties, the inhalation and dermal route are not appropriate, and the default oral route of administration is most appropriate (ECHA R7a Guidance p 342). Additional inhalation testing would therefore neither lead to a better risk assessment, nor improve the safety of applications. On the basis of the argumentation summarized above an acute inhalation toxicity is waived.

 

Justification for selection of acute toxicity – oral endpoint Key study 

Justification for selection of acute toxicity – dermal endpoint Key study

Justification for classification or non-classification

As LD50 values were above limit dose of 2000 mg/kg bw for oral and dermal application, the test item containing 70% active ingredient does not need to be classified and has no obligatory labelling requirement for acute oral and dermal toxicity according to the EC Directive (No.93/21/EEC) and CLP (No. 1272/2008 of 16 December 2008).