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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: Study non-GLP with limited data on study design, however the study was conducted to state of the art methods at that time period. The study is therefore 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)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 1,2-bis(pentyloxycarbonyl)ethanesulphonate
EC Number:
213-085-6
EC Name:
Sodium 1,2-bis(pentyloxycarbonyl)ethanesulphonate
Cas Number:
922-80-5
Molecular formula:
C14H26O7S.Na
IUPAC Name:
sodium 1,4-dioxo-1,4-bis(pentyloxy)butane-2-sulfonate
Test material form:
other: waxy solid
Details on test material:
Test material
- Name of test material (as cited in study report): Aerosol AY; sodium diamylsulfosuccinate
- Physical state: White, waxy solid
- Analytical purity: >97%
- Impurities (identity and concentrations): See confidential details
- Composition of test material, percentage of components: See confidential details
- Isomers composition: Not provided
- Purity test date: Not provided
- Lot/batch No.: SPS 900A-MH
- 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:
other: Aerosol AY was moistened with sufficient water to form a paste
Details on dermal exposure:
TEST SITE
- Area of exposure: closely clipped skin of the abdomen
- Type of wrap if used: a cuff of polyethylene film which encircled the trunk of the animal

REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.5 g/kg, 5 g/kg and 10 g/kg
- For solids, paste formed: yes

VEHICLE
- Amount(s) applied (volume or weight with unit): The dose was moistened with sufficient water to form a paste.
Duration of exposure:
24 hours
Doses:
dosages of 2.5g/kg, 5 g/kg and 10 g/kg ; Aerosol AY was moistened with sufficient water to form a paste.
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 500 mg/kg bw
Based on:
test mat.
Mortality:
Two out of five rabbits died at a dosage of 10 g/kg and one out of five succumbed at 5 g/kg.
Clinical signs:
Moderate to severe erythema and edema were present in all cases at the end of the exposure period. The edema was greatly reduced by the second day after dosing, and has subsided almost completely by the third day. Erythema persisted to a slight degree a day or two longer.
Other findings:
Moderate to severe erythema and edema were present in all cases at the end of the exposure period. The edema was greatly reduced by the second day after dosing, and has subsided almost completely by the third day. Erythema persisted to a slight degree a day or two longer.
Apart from varying degrees of depression, most animals gave no evidence of systemic toxicity on the day following that of application of the dose. On the second day, however, one animal of the 10 g/kg group exhibited extreme depression and apparent loss of control of the hind legs which were fully extended anteriorly. Altough the animal could hold his head erect, it refused or was unable to attempt movement when placed on the floor. This condition is believed to have been the result of some incidental traumatic injury rather than a consequence of the dose. The animal died on the fourth day. There was another death in the 10 g/kg group, this on the sixth day, and a death at the 5 g/kg level on the sixth day. An LD50 of the product cannot be calculated from these results, although it is certainly greater than 2.5 g/kg. Survivors were observed for a total of seven days after that of the dose, and were then sacrificed. No significant pathology was find by gross autopsy.

Any other information on results incl. tables

Table 1: Aerosol AY: Single Doses to Male Albino Rabbits by Skin Application. Product Administered as an Aqueous Paste Under Polyethylene Film for 24 Hours.

 

Animal Number

Body Weight in Grams

Weight Change in 7 Days

Dosages in g/kg

Dose in Grams

Days to Death

H 745

3075

-44

10.0

30.8

S

H 746

3250

-645

10.0

32.5

S

H 747

3312

-

10.0

33.1

6

H 748

3281

-

10.0

32.8

4

H 749

3301

-583

10.0

33.0

S

 

 

 

 

 

 

H 794

3203

-107

5.0

16.1

S

H 795

3383

-245

5.0

16.9

S

H 797

3668

-636

5.0

18.3

S

H 798

3625

-

5.0

18.1

6

H 799

3802

-390

5.0

19.0

S

 

 

 

 

 

 

H 804

3000

-532

2.5

7.5

S

H 805

3520

-331

2.5

8.8

S

H 806

3270

-257

2.5

8.2

S

H 807

3675

-199

2.5

9.2

S

H 808

3500

-386

2.5

8.8

S

S= Survived

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Application of dosages of 2.5 g/kg to 10 g/kg as an aqueous paste to the clipped skin of rabbits for 24 hours led to moderate to severe erythema and edema which persisted for three to four days. Two out of five rabbits died at a dosage of 10 g/kg and one out of five succumbed at 5 g/kg.
LD50 > 2500 mg/kg bw.
Executive summary:

Three groups of male albino rabbits, 5 animals per group, received single applications of the test item on the closely-clipped skin of the abdomen at dosages of 2.5 g/kg, 5 g/kg and 10 g active ingredient/kg bw, respectively.

The dose was moistened with sufficient water to form a paste, and retained in contact with the skin for 24 hours by means of a cuff of polyethylene film which was 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.

Moderate to severe erythema and edema were present in all cases at the end of the exposure period. The edema was greatly reduced by the second day after dosing, and has subsided almost completely by the third day. Erythema persisted to a slight degree a day or two longer.

Apart from varying degrees of depression, most animals gave no evidence of systemic toxicity on the day following that of application of the dose. On the second day, however, one animal of the 10 g/kg group exhibited extreme depression and apparent loss of control of the hind legs which were fully extended anteriorly. Although the animal could hold his head erect, he refused or was unable to attempt movement when placed on the floor. This condition is believed to have been the result of some incidental traumatic injury rather than a consequence of the dose. The animal died on the fourth day. There was another death in the 10 g/kg group, this on the sixth day, and a death at the 5 g/kg level on the sixth day. An LD50 of the product cannot be calculated from these results, although it is certainly greater than 2.5 g/kg. Survivors were observed for a total of seven days after that of the dose, and were than sacrificed. No significant pathology was find by gross autopsy.