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Toxicological information

Acute Toxicity: dermal

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Administrative data

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.

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 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
semi-solid (amorphous): gel
Remarks:
migrated information: paste
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 can be assumed that the substance is a paste
- 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:
rabbit
Strain:
other: albino
Sex:
male
Details on test animals and environmental conditions:
Not provided

Administration / exposure

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

Results and discussion

Effect levelsopen allclose all
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

Any other information on results incl. tables

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.

Applicant's summary and conclusion

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.