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Administrative data

Description of key information

Oral (similar to OECD 401), rat: LD50 calculated = 1550 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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.
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
Species:
rat
Strain:
not specified
Sex:
not specified
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
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.

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

 

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.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
1 550 mg/kg bw
Quality of whole database:
The available information comprises an adequate and reliable study (Klimisch score 2), and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Oral

The acute oral toxicity of the test substance was assessed in a study similar to OECD Guideline 401 (1977). The test substance was administred orally in doses of 840, 2050, 4000, 5000 and 6250 mg/kg bw to 10 rats per group. In the 840 mg/kg bw dose group one animal died within 24 h, two additional animals each on Day 5 and 6. In the 2050 and 4000 mg/kg bw dose groups five animals died within 24 h. In the 4000 mg/kg bw dose group seven animals died within 24 h, two additional animals on Day 2 and one on Day 6. In the dose groups of 5000 and 6250 mg/kg bw five and seven animals were found dead within 24 h and one additional animal on Day 2, respectively. Animals were found lethargic, flaccid and showed ptosis, piloerection and convulsion. At gross pathology reddening or yellowish colour of the stomach, abdominal wall and intestines, dark liver, kidneys and lungs, exudate of mouth and nose, blood in lumen of intestine and bladder and signs of cannibalism were found. The LD50 for rats was calculated to be 1550 mg/kg bw.

Justification for classification or non-classification

The available data on acute oral toxicity of the test substance meet the criteria for Acute Tox. 4 (H302) according to Regulation (EC) 1272/2008.