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: 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 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
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:
rat
Strain:
other: albino
Sex:
male
Details on test animals or test system and environmental conditions:
Not provided

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
Aerosol MA-80% was diluted with water to a solution of 5% solids.
The doses were 0.31 g/kg, 0.63 g/kg, 1.25 g/kg and 2.50 g/kg in terms of solids (active ingredient).
No. of animals per sex per dose:
5 males
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: not provided
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
method of moving averages

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
1 750 mg/kg bw
Based on:
act. ingr.
Remarks on result:
other: no range calculable
Mortality:
All animals died within 24 hours following 2.5 g act. ingr./kg bw, but all survived at the lower dosages.
Clinical signs:
Following lethal doses the animals exhibited profound depression and severe diarrhea prior to death.
At the lower dosages the animals were depressed to greater or lesser degree for 24 to 48 hours, but thereafter regained normal appearance and behavior.
Body weight:
No relevant differences between groups.
Gross pathology:
Moderate to severe irritation with hemorrhage of the gastrointestinal tract was found at post-mortem examination in the high dose group.
At autopsy there was a greater than usual distension of the intestines in some instances, but otherwise no significant gross findings in the other dose groups.

Any other information on results incl. tables

Table 1: Dosage & Results

Animal Number

Body weight in Grams

Weight Change in 7 Days

Dosage in g act.ingr./kg bw

Dose in Grams

Dose in ml of Solution

Days to Death

R 9973

103

-

2.50

0.26

5.2

<1

R 9974

109

-

2.50

0.28

5.5

<1

R 9977

106

-

2.50

0.27

5.3

<1

R 9979

94

-

2.50

0.24

4.7

<1

R 9980

94

-

2.50

0.24

4.7

<1

 

 

 

 

 

 

 

R 9982

101

10

1.25

0.13

2.5

S

R 9983

90

25

1.25

0.12

2.3

S

R 9985

90

24

1.25

0.12

2.3

S

R 9988

101

24

1.25

0.13

2.5

S

R 9989

116

40

1.25

0.15

2.9

S

 

 

 

 

 

 

 

R 9990

91

22

0.63

0.06

1.14

S

R 9993

99

6

0.63

0.06

1.24

S

R 9995

96

6

0.63

0.06

1.20

S

R 9996

101

14

0.63

0.06

1.26

S

R 9997

108

19

0.63

0.07

1.35

S

 

 

 

 

 

 

 

R 9998

96

12

0.31

0.03

0.61

S

R 9999

98

12

0.31

0.03

0.62

S

R 10000

100

37

0.31

0.03

0.63

S

R 10001

90

19

0.31

0.03

0.57

S

R 10002

97

13

0.31

0.03

0.61

S

S= Survived

LD50=1.75 g/kg (No Range Calculable)

NOTE: For purposes of calculation of an LD50by the method of moving averages, a mortality of 5/5 at

5g/kg is assumed.

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 of Butanediodic acid, sulfo-, 1,4-bis(1,3-dimethylbutyl) ester, sodium salt is 1.75 g/kg in terms of solids content (active ingredient), and the test item is considered, therefore, to be a slightly toxic by ingestion at single dose. NOTE: For purposes of calculation of an LD50 by the method of moving averages, a mortality of 5/5 at 5g/kg bw is assumed.
Executive summary:

The test item as received (80% solids) was diluted with water to a solution of 5% solids content (act. ingr.), and administered in single doses by gavage to groups of young, male albino rats at dosages ranging from 310, 630, 1250 and 2500 mg act. ingr./kg. All animals died within 24 hours following 2500 mg/kg, but all survived at the lower dosages. The acute oral LD50 was calculated to be 1750 mg active ingredient/kg with no confidence limits determinable. Following lethal doses the animals exhibited profound depression and severe diarrhea prior to death. Moderate to severe irritation with haemorrhage of the gastrointestinal tract was found at post-mortem examination. At the lower dosages the animals were depressed to greater or lesser degree for 24 to 48 hours, but thereafter regained normal appearance and behaviour. They were observed for a total of seven days following the dose, and then sacrificed. At autopsy there was a greater than usual distension of the intestines in some instances, but otherwise no significant gross findings.