Registration Dossier

Administrative data

Description of key information

In an early acute oral study with acceptable scientific method a LD50 of 2420 mg/kg (95th percentiles: 2200 -2710 mg/kg) was reported.

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:
other: Non-GLP study with limited information on test material, test animals, study design and clinical examination
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
limited test material, testing animal and study design information
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male
Route of administration:
oral: gavage
Vehicle:
water
Doses:
1500, 2000, 2200, 2500, 3100 and 5000 mg/kg bw
No. of animals per sex per dose:
10 males
Control animals:
no
Sex:
male
Dose descriptor:
LD50
Effect level:
2 420 mg/kg bw
Based on:
test mat.
95% CL:
2 200 - 2 710

Table 1: Mortality data

Dose [g/kg bw]

Time to death [days]

Mortality

Number of dead/total animals

1.5

-

0/10

2.0

3

1/10

2.2

2-3

4/10

2.5

2

7/10

3.1

2

8/10

5.0

3-6

10/10

Executive summary:

Early study with acceptable scientific method. LD50: 2420 mg/kg (95th percentiles: 2200 -2710 mg/kg)

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
2 420 mg/kg bw
Quality of whole database:
early study with acceptable scientific method but limied documentation

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

Justification for classification or non-classification

No classification is warranted because in an early acute oral study with an acceptable scientific method a LD50 of 2420 mg/kg (95th percentiles: 2200 -2710 mg/kg) was reported.