Sodium 1,4-bis(1,3-dimethylbutyl) sulphonatosuccinate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1957

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.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1957

Report date:

1957

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 1,4-bis(1,3-dimethylbutyl) sulphonatosuccinate

EC Number:

219-147-9

EC Name:

Sodium 1,4-bis(1,3-dimethylbutyl) sulphonatosuccinate

Cas Number:

2373-38-8

Molecular formula:

C16H30O7S.Na

IUPAC Name:

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

Test material form:

liquid: viscous

Details on test material:

- Name of test material (as cited in study report): Aerosol MA-80%, sodium dihexylsulfosuccinate
- Physical state: Clear, viscous liquid (80% solution)
- Analytical purity: 78-80%
- 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.: BV-1193A NH
- Expiration date of the lot/batch: Not provided
- Stability under test conditions: Good stability in aqueous solution
- 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
trunk

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the cuff and any excess of the dose were removed
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.5 mL/kg; 5 mL/kg; 10 mL/kg
- Concentration (if solution): solution containing 80 % solids ( 80 % active ingredient)
- Constant concentration used: yes; different volumes

VEHICLE
Not applicable

Duration of exposure:

24 hours

Doses:

2.5 mL/kg, 5.0 mL/kg and 10.0 mL/kg

No. of animals per sex per dose:

4

Control animals:

no

Details on study design:

TEST SITE
- Area of exposure: trunk
- % coverage: Not provided
- Type of wrap if used: a cuff of polyethylene film

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the cuff and any excess of the dose were removed
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.5 mL/kg, 5.0 mL/kg and 10.0 mL/kg
- Concentration (if solution): 80%
- Constant concentration used: different volumes

Statistics:

the method of moving averages

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

5 mL/kg bw

Based on:

test mat.

95% CL:

> 2.6 - < 9.6

Remarks on result:

other: test material is 80% solution

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

4 000 mg/kg bw

Based on:

act. ingr.

95% CL:

> 2 100 - < 7 700

Mortality:

At a dosage of 10 mL/kg there was severe erythema, edema and necrosis of the skin, and all animals died within one to three days following the removal of the dose . At the two lower dosages, there was one death each.

Clinical signs:

other: At a dosage of 10 mL/kg there was severe erythema, edema and necrosis of the skin, and all animals died within one to three days following the removal of the dose having exhibited extreme depression over this interval. Erythema and edema were initially q

Gross pathology:

Post-mortem examination in the high dose group gave additional evidence of severe injury to the skin and abdominal wall.
Survivors were observed for a total of 7 days after application of the dose, and then sacrificed. At autopsy there was no gross pathology that could be related to administration of the product.

Any other information on results incl. tables

Table 1. Dosage & Results

Animal Number	Body weight in Grams	Weight Change in 7 Days	Dosage in mL/kg	Dose in mL	Days to Death
H 815	3372	-	10.0	33.7	3
H 817	3562	-	10.0	35.6	2
H 818	3900	-	10.0	39.0	2
H 819	3580	-	10.0	35.8	<1
H 821	2720	-	10.0	27.2	<1
H 823	3680	-160	5.0	18.4	S
H 824	3142	-	5.0	15.7	4
H 825	4098	-987	5.0	20.5	S
H 826	3091	-182	5.0	15.5	S
H 832	3729	-161	2.5	9.3	S
H 833	3557	-237	2.5	8.9	S
H 835	3805	-	2.5	9.5	4
H 836	4120	-408	2.5	10.3	S

S= Survived

LD₅₀ =5.0 (2.6-9.6) mL/kg as 80% solution

LD₅₀ =4.0 (2.1-7.7) g/kg as contained solids

 

NOTE: For purposes of calculation of anLD₅₀ by the method of moving averages, a mortality of 4/4 at

20 mL/kg is assumed.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of the test item for male albino rabbits by single skin application under these circumstances is 5.0 (2.6-9.6) mL/kg, corresponding with 4.0 g/kg bw of the active ingredient.
For purposes of calculation of an LD50 by the method of moving averages a mortality of 4/4 at 20 mL/kg is assumed.

Executive summary:

The test item as received (solution containing 80% solids) was supplied to the closely-clipped skin of male albino rabbits in single doses that remained in contact with the skin for a period of 24 hours. Four animals were used at each of three dosage levels; namely, 2.5 mL/kg, 5 mL/kg and 10 mL/kg respectively. The dose was retained by means of a cuff of polyethylene film which encircled the trunk of the animal. At the end of the period of exposure, the cuff and any excess of the dose were removed, and the skin examined for primary irritation.

At a dosage of 10 mL/kg there was severe erythema, edema and necrosis of the skin, and all animals died within one to three days following the removal of the dose having exhibited extreme depression over this interval. Post-mortem examination gave additional evidence of severe injury to the skin and abdominal wall. At the two lower dosages, there was one death each, and the LD₅₀ was calculated to be 5.0 (2.6-9.6) mL/kg, or 4.0 g/kg bw of the active ingredient.

Erythema and edema were initially quite severe at the lower dosages, but the edema subsided within 24 to 48 hours. Erythema, however, persisted for 4 to 5 days. Survivors were observed for a total of 7 days after application of the dose, and then sacrificed. At autopsy there was no gross pathology that could be related to administration of the product.