Sodium 1,4-diisotridecyl sulphonatosuccinate

Acute Toxicity: dermal

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

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 1,4-diisotridecyl sulphonatosuccinate

EC Number:

259-515-6

EC Name:

Sodium 1,4-diisotridecyl sulphonatosuccinate

Cas Number:

55184-72-0

Molecular formula:

C30H58O7S.Na

IUPAC Name:

sodium 1,4-bis[(2-methyldodecyl)oxy]-1,4-dioxobutane-2-sulfonate

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 or test system 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 levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 mL/kg bw

Based on:

test mat.

Remarks:

=70% aqueous solution

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

> 3 500 mg/kg bw

Based on:

act. ingr.

Mortality:

No

Clinical signs:

other: other: 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.

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.