Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
no details available

ENVIRONMENTAL CONDITIONS
no details available

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
no details available
Doses:
1220, 2470, 5000, 10140 mg/kg bw
No. of animals per sex per dose:
10 animals / dose
Control animals:
other: not required
Details on study design:
no details available

Results and discussion

Preliminary study:
no details available
Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
3 900 mg/kg bw
Based on:
test mat.
95% CL:
> 2 700 - < 5 500
Mortality:
1220 mg/kg bw: 0/10
2470 mg/kg bw: 1/10
5000 mg/kg bw: 8/10
10140 mg/kg bw: 10/10
Clinical signs:
1220 mg/kg bw: Chromorhinorrhea, piloerection, lethargy
2470 mg/kg bw: Diarrhea, chromorhinorrhea, piloerection, lethargy, prostration, ataxia, ptosis, chromodacryorrhea, tachypnea, tremors, right eye crust shut
5000 mg/kg bw: Piloerection, lethargy, ptosis, coma, body cold
10140 mg/kg bw: None
Body weight:
not specified
Gross pathology:
see table below

Any other information on results incl. tables

Necropsy observations:

Doses mg/kg

1220

2470

5000

10140

Normal

8

9

1

 

Cannibalized

 

1

 

 

Exudate, nose/mouth, yellow

 

 

2

3

Intestines, areas red

 

 

7

8

Intestines, areas yellow

 

 

5

10

Intestines, bloated

 

 

 

1

Stomach, areas red

 

 

9

 

Liver dark

 

 

7

7

Liver mottled

 

 

1

 

Lungs dark

 

 

5

5

Lungs areas dark

 

 

2

4

Kidney dark

 

 

 

6

Kidney mottled

1

 

1

 

Kidney pale

 

 

1

 

Spleen large

1

 

 

 

Applicant's summary and conclusion

Conclusions:
In an acute oral toxicity study the LD50 was determined to be 3900 mg/kg bw.
Executive summary:

In a study performed 1978, the acute oral toxicity of the test item was determined. The study was conducted with 10 rats per group. The test item was administered in doses of 1220, 2470, 5000 and 10140 mg/kg bw. The animals were observed for mortality and/or systemic effects. Mortality was observed in doses from 2470 mg/kg bw onwards. The LD50 was determined to be 3900 mg/kg bw.