Registration Dossier

Administrative data

Description of key information

Oral (comparable to OECD 401), rat: LD50 = 3900 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
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Reference:
Composition 0
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 information:
Composition 1
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

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
Preliminary study:
no details available
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

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

 

 

 

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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
3 900 mg/kg bw

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

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.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on acute toxicity, the test item is not classified according to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Regulation (EU) No 2017/776.