Sodium 1,2-diisobutoxycarbonylethanesulphonate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1969

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study is performed in male animals only, with a +-45% active ingredient formulation, and not under GLP compliance. The study is conducted similar to OECD standard and shows consistent results, therefore the study is considered to be adequate, reliable and relevant.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1969

Report date:

1969

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

male animals only

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 1,2-diisobutoxycarbonylethanesulphonate

EC Number:

204-839-5

EC Name:

Sodium 1,2-diisobutoxycarbonylethanesulphonate

Cas Number:

127-39-9

Molecular formula:

C12H22O7S.Na

IUPAC Name:

sodium 1,4-diisobutoxy-1,4-dioxobutane-2-sulfonate

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): AEROSOL® IB, Sodium di-iso-butyl sulfosuccinate
- Physical state: Not provided
- Analytical purity: 44-46 %
- 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:

water

Details on dermal exposure:

TEST SITE data: Not provided

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

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5 g/kg
- Concentration (if solution): Not provided
- Constant volume or concentration used: yes
- For solids, paste formed: yes

VEHICLE: Not applicable

Duration of exposure:

24 hours

Doses:

5.0 g/kg

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations:daily
- Necropsy of survivors performed: yes
- Other examinations performed: body weight initial & terminal

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 250 mg/kg bw

Based on:

act. ingr.

Mortality:

0/10

Clinical signs:

other: Signs of intoxication: None observed Skin irritation: Well-defined erythema and slight edema followed by desiccation of skin Gross autopsy: Normal

Gross pathology:

Normal

Any other information on results incl. tables

Table1. Body weights and clinical observations

Dosage	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 g/kg										0/10	2.91	3.10

I: initial; T: terminal

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

No signs of intoxication and normal gross autopsy were observed at the dosage of 5g/kg of the test item in a 24-hour occlusive contact with shaved skin of male albino rabbits. There was a well-defined erythema and slight edema by desiccation of the skin.

Executive summary:

Acute dermal toxiciy study was tested in 10 male albino rabbits under covered application to the clipped skin of 5 g test item containing 44 -46% active ingredient (2250 mg act.ingr./kg bw). There were no mortalities, no signs of intoxication and no gross autopsy. There was a well-defined erythema and slight edema by desiccation of the skin. The LD₅₀ was >5 g/kg bw (corresponding with >2250 mg act.ingr./kg bw).