Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1969
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
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:
reference to same study

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:
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): Surfactant E-196 (80% active)
- Physical state: Not provided, however it is assumed to be a viscous liquid
- Analytical purity: 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.: 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:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Not provided
- Age at study initiation: Not provided
- Weight at study initiation: mean weight 150-151 g
- Fasting period before study: 24 hours
- Housing: Not provided
- Diet (e.g. ad libitum): Not provided
- Water (e.g. ad libitum): Not provided
- Acclimation period: Not provided

ENVIRONMENTAL CONDITIONS
Not provided

IN-LIFE DATES: Not provided

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 20% w/v aqueous solution
- Justification for choice of vehicle: high solubility


MAXIMUM DOSE VOLUME APPLIED: 10.0 g/kg


Doses:
10.0, 5.0, 2.5 and 1.25 g test item/kg bw.
No. of animals per sex per dose:
5 males per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Frequency of observations=daily; Initial and
Terminal weighing
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
Not provided

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
3 540 mg/kg bw
Based on:
dissolved
Remarks:
20% w/v aqueous dispersion of the product
Sex:
male
Dose descriptor:
LD50
Effect level:
2 830 mg/kg bw
Based on:
act. ingr.
Mortality:
5/5 animals in the 10.0 g/kg and 5.0 g/kg dose group died in the first 6 hours after dosing .
0/5 animals in the 2.5 g/kg and 1.25 g/kg dose group died during the 14 day observation period.
Clinical signs:
Diarrhea, lethargy, prostration, comatose
Body weight:
See Table 1
Gross pathology:
Survivors-normal
Other findings:
None

Any other information on results incl. tables

Table 1: Single oral dose Surfactant E-196 (80% active) in male albino rats.

              Animals fasted for 24 hours were dosed with 20% w/v aqueous dispersion of the product.

 

Dosage

Onset of (S) Signs, (D) Death, Hours and Days

DIED

Mean Wt.

Time of Recovery, Days

0-6

6-24

2

3

4

5

6

7

8-14

DOSED

I

T

1

2

3

4

5

6

7-14

10.0 g/kg

SD5

 

 

 

 

 

 

 

 

5/5

151

-

 

 

 

 

 

 

 

 5.0 g/kg

SD5

 

 

 

 

 

 

 

 

5/5

150

-

 

 

 

 

 

 

 

 2.5 g/kg

S

 

 

 

 

 

 

 

 

0/5

151

255

R

 

 

 

 

 

 

 1.25 g/kg

S

 

 

 

 

 

 

 

 

0/5

150

265

R

 

 

 

 

 

 

 

LD50= 3.54 g/kg with no range calculable (20% w/v dispersion)

Signs of intoxication: Diarrhea, lethargy, prostration, comatose.

Gross Autopsy: Survivors-normal.

 

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 of Surfactant E-196 (80% active) dosed as an 20% w/v aqueous dispersion = 3.54 g/kg with no calculable range.
The product is considered to be slightly toxic by ingestion in single doses at very high doses (above limit dose) .
Executive summary:

Oral acute toxicity was tested in 5 male albino Wistar rats with a 20% w/v aqueous dispersion of Butanedioic acid, sulfo-, 1,4 -dicyclohexyl ester, sodium salt (80% purity) at 10000, 5000, 2500 and 1250 mg test item/kg bw. In the 10000 and 5000 mg/kg bw dose group all 5 animals died within 6 hours after dosing. In the 2500 and 1250 mg/kg bw dose group all animals survived the 14 days observation period. In all dose groups signs of intoxication were observed ( diarrhea, lethargy, prostration, comatose) and gross autopsy of the survivors was normal.The LD50 was calculated to be 3540 mg/kg; taking into account that the product contained 80% active ingredient LD 50 is corresponding to 2830 mg act.ingr./kg bw.