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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.