Registration Dossier

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:
comparable to guideline study with acceptable restrictions
Remarks:
Limited documentation. No information on analytical purity of test substance given.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
Limited documentation. No information on analytical purity of test substance given.
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

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Doses:
840, 2050, 4000, 5000 and 6250 mg/kg bw
No. of animals per sex per dose:
10 in total
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, gross pathology

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
1 550 mg/kg bw
Based on:
test mat.
Mortality:
840 mg/kg bw: 3/10 animals died
2050 mg/kg bw: 5/10 animals died
4000 mg/kg bw: 10/10 animals died
5000 mg/kg bw: 6/10 animals died
6250 mg/kg bw: 8/10 animals died
Clinical signs:
840 mg/kg bw: No clinical signs were observed within study period.
2050 mg/kg bw: lethargy and flaccidity
4000 mg/kg bw: lethargy, ptosis, piloerection and convulsions in one animal
5000 mg/kg bw: lethargy, ptosis, piloerection
6250 mg/kg bw: lethargy, ptosis, piloerection
Body weight:
not specified
Gross pathology:
Gross pathology of animals revealed red / yellow stomach and intestine, yellow exudate of nose and mouth in one animal, yellow coloured portions of interior abdominal wall, blood in lumen of intestine, red small intestine, blood in bladder, dark liver, kidney and lungs and signs of cannibalization.

Any other information on results incl. tables

Table 1. Results of the acute oral toxicity study.

Dose level (mg/kg bw)

Mortalities

 

n

840

3/10

2050

5/10

4000

10/10

5000

6/10

6250

8/10

 

Table 2. Clinical signs found in necropsy.

 

 

Clinical signs

No of rats with clinical sign at respective dose [mg/kg bw]

840

2050

4000

5000

6250

Red stomach and intestine

1

0

1

2

0

Yellow stomach and intestine

0

4

5

4

7

Dark liver

0

3

2

3

7

Yellow exudate of nose and mouth

1

4

8

2

7

Yellow portions of interior abdominal wall

0

1

3

1

1

Blood in lumen of intestine

0

0

1

1

1

Red small intestine

0

2

3

0

6

Blood in bladder

0

1

0

0

1

Dark kidneys

0

0

0

0

5

Dark lungs

0

2

3

0

1

Signs of cannibalization

1

0

0

0

0

 

Applicant's summary and conclusion

Interpretation of results:
other: Acute Tox. 4 according to Regulation (EC) No 1272/2008
Conclusions:
In this acute oral toxicity study a LD50 value of 1550 mg/kg bw was derived in rats.