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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: scientifically acceptable study report, well documented, suitable for assessement

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report Date:
1971

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
10 rats per sex and dose were treated simultaneously with different doses of the test item by gavage. The animals were observed for 14 days for clinical signs. Gross pathology was performed for all of the treated animals.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Mean body weight: males ca. 216 g, females ca. 156 g
The animals were offered a standardized animal laboratory diet as well as tap water ad libitum.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
The test concentration used was 10% (10% aqueous emulsion with CMC).
Doses:
640, 800, 1000, 1250, 1600, 2000, 2500, 3200 mg/kg
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Statistics:
The LD50 was calculated using the method of LITCHFIELD-WILCOXON.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
950 mg/kg bw
Mortality:
640 mg/kg: 2/20 after 14 days; 800 mg/kg: 4/20 after 14 days; 1000 mg/kg: 13/20 after 14 days; 1250 mg/kg: 16/20 after 14 days; 1600, 2000, 2500, 3200 mg/kg: 20/20 after 14 days
Clinical signs:
2600, 2000, 2500 and 3200 mg/kg: dyspnea, slight trembling spasms, apathy, diarrhea, secretion out of the oral cavity, red-agglutinated eyes and noses.
640, 800, 1000 and 1250 mg/kg: dyspnea, scretion out ofthe oral cavity; surviving animals after 6 days without findings.
Body weight:
no data
Gross pathology:
Animals that died: intestine atony, diarrhea, general venous congestion.
Sacrificed animals: inner organs macroscopically without pathological findings.

Any other information on results incl. tables

Dose (mg/kg bw)

Conc. (%)

Treated animals

Mortality after

1 h

24 h

48 h

7 days

14 days

3200

10

10 males, 10 females

8/10     3/10

10/10  6/10

10/10 10/10

10/10  10/10

10/10   10/10

2500

10

10 males, 10 females

0/10

0/10

7/10

3/10

10/10  9/10

10/10   10/10

10/10   10/10

2000

10

10 males, 10 females

0/10

0/10

3/10   0/10

5/10  4/10

10/10 

 10/10

10/10

10/10

1600

10

10 males, 10 females

0/10 

0/10

0/10 

0/10

5/10  

0/10

10/10

10/10

10/10 

 10/10

1250

10

10 males, 10 females

0/10 

0/10

0/10 

0/10

0/10 

0/10

9/10  

7/10

9/10  

7/10

1000

10

10 males, 10 females

0/10 

0/10

0/10 

0/10

0/10 

0/10

6/10  

7/10

6/10  

7/10

800

10

10 males, 10 females

0/10 

0/10

0/10 

0/10

0/10

0/10

0/10  

3/10

0/10  

3/10

640

10

10 males, 10 females

0/10 

0/10

0/10 

0/10

0/10 

0/10

1/10 

1/10

1/10  

1/10

The LD50 was calculated using the method of LITCHFIELD-WILCOXON: LD50 = 950 (851 - 1062) mg/kg bw.

Applicant's summary and conclusion

Executive summary:

The LD50 was calculated using the method of LITCHFIELD-WILCOXON: LD50 = 950 (851 - 1062) mg/kg bw.