Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
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:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
7 days observation period
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:
- 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: Good stability in aqueous solution
- Storage condition of test material: Not provided


Test animals

Species:
rat
Strain:
other: albino
Sex:
male
Details on test animals or test system and environmental conditions:
Not provided

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
water
Remarks:
20% aqueous solution
Doses:
10.0 g/kg, 5.0 g/kg, 2.5 g/kg, 1.25 g/kg
No. of animals per sex per dose:
5 males per dose
Control animals:
no
Details on study design:
The product (Aerosol AY) was administered to groups of young, male albino rats (5 animals per group) as an 20% aqueous solution at dosages ranging from 1.25 g/kg to 10 g/kg.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 4 650 mg/kg bw
Based on:
act. ingr.
95% CL:
> 3 000 - < 7 250
Mortality:
Death occurred fairly promptly following lethal doses, usually within one-half to one hour.
From the number and distribution of deaths, the LD50 of the product is calculated as 4650 (3000-7250) mg/kg bw.
Clinical signs:
Survivors exhibited varying degrees of depression for periods up to 24 hours following the dose, but thereafter maintained a normal appearance and behavior for remainder of a 7-day observation period.
Gross pathology:
They were sacrificed at the end of this time, and gross autopsy disclosed no pathology that could be attributed to the dose.

Any other information on results incl. tables

Table 1: Aerosol AY: Single Dose to Male Albino Rats by Mouth. Product Administered as a Solution in Water, 1 mL= 0.2 g.

 

Animal Number

Body weight in Grams

Weight Change in 7 Days

Dosage in g/kg

Dose in Grams

Dose in mL of Solution

Days to Death

R 9956

93

-

10.0

0.94

4.7

<1

R 9957

107

-

10.0

1.08

5.4

<1

R 9958

111

-

10.0

1.12

5.6

<1

R 9959

110

-

10.0

1.10

5.5

<1

R 9960

102

-

10.0

1.02

5.1

<1

 

 

 

 

 

 

 

R 9961

110

-

5.0

0.55

2.75

<1

R 9962

106

-

5.0

0.53

2.65

<1

R 9965

105

20

5.0

0.53

2.63

S

R 9966

98

28

5.0

0.49

2.45

S

R 9967

102

34

5.0

0.51

2.55

S

 

 

 

 

 

 

 

R 9968

103

-

2.5

0.26

1.29

<1

R 9969

104

34

2.5

0.26

1.30

S

R 9970

106

20

2.5

0.27

1.33

S

R 9971

98

37

2.5

0.25

1.23

S

R 9972

114

49

2.5

0.29

1.43

S

 

 

 

 

 

 

 

R 9877

90

28

1.25

0.11

0.57

S

R 9880

92

30

1.25

0.12

0.58

S

R 9881

93

35

1.25

0.12

0.59

S

R 9884

90

26

1.25

0.11

0.57

S

R 9890

94

2

1.25

0.12

0.59

S

S= Survived

LD50= 4.65 (3.00-7.25) g/kg

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 of Aerosol AY dosed as a 20% aqueous solution to male albino rats is 4.65 (3.00-7.25) g/kg .
Executive summary:

The test item was administered to groups of young, male albino rats (5 animals per group) as an 20% aqueous solution at dosages ranging from 1.25 g/kg to 10 g active ingredient/kg bw. Death occurred fairly promptly following lethal doses, usually within one-half to one hour, and post-mortem examination revealed moderate to severe hemorrhage of the entire gastrointestinal tract. From the number and distribution of deaths, the LD50 of the product is calculated as 4.65 (3.00-7.25) g/kg. Survivors exhibited varying degrees of depression for periods up to 24 hours following the dose, but thereafter maintained a normal appearance and behavior for remainder of a 7-day observation period. They were sacrificed at the end of this time, and gross autopsy disclosed no pathology that could be attributed to the dose.