Registration Dossier

Administrative data

Description of key information

 LD50(oral) = 5000 mg/kg bw; LC50(inhal) > 2.8 mg/l; LD50(ip) = 380 mg/kg bw.

  
    
    
    
    
    
    
    
    
    

Acute intraperithoneal administration: LD50

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
other: read across from supporting substance
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Remarks:
Study conducted before 1981
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 7 weeks
- Weight at study initiation: 192 g (♂) and 151 g (♀).
- Housing: Rats were caged singly
- Diet: A commercial pelleted diet ad libitum
- Water: ad libitum
- Fasting period before study: 18 hours

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2 °C
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: a 25 % (w/v) suspension of the compound in tap water.
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 per sex per dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
Deaths and clinical symptoms wars recorded. At the end of the observation period, surviving animals were killed by exsanguination under ether anaesthesia and an autopsy performed.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD0
Effect level:
ca. 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred during the 14 day observation period.
Clinical signs:
No clinical symptoms were recorded
Gross pathology:
At autopsy no changes in organs or tissues caused by the administration of the test compound were seen.
Interpretation of results:
other: Not classified according to the CLP Regulation (EC n. 1272/2008)
Conclusions:
LD50(male/female) > 5000 mg/kg bw
Executive summary:

The substance has been tested for acute toxicity after oral exposure, the test item was administered by gavage in a single dose of 5000 mg/kg bw to rats (5 male and 5 female).

After the administration, the animals were observed for 14 days. No deaths occurred and no clinical symptoms were recorded.

The acute oral median lethal dose LD50 of test item in rats is greater than 5000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute oral administration:

Three studies are available on acute oral toxicity conducted on similar substance 1.

The Key study (Huntsman, 1975) was performed with a method similar to the OECD Guideline 401. The test item was administered to rats in a single dose by gavage at the concentration of 5000 mg/kg bw. No deaths occurred during the observation period.

LD50 > 5000 mg/kg bw

As supporting studies the two other studies available on similar substance 1 were reported:

The first study (BASF, 1979) was performed with a method similar to the OECD Guideline 401. The test item was administered to rats in a single dose by gavage in distilled water at the concentration of 2000 mg/kg bw. No deaths occurred during the observation period.

LD50 > 2000 mg/kg bw

The second study (BASF, 1979) was performed with a method similar to the OECD Guideline 401. . The test item was administered to rats in a single dose by gavage in CMC (carboxymethyl cellulose) at the concentration of 5000 mg/kg bw. No deaths occurred during the observation period, nevertheless blue urine and foeces were observed.

LD50 > 5000 mg/kg bw

The three study of acute oral administration are similar, the main reason for selection is the highest purity of the Huntsman study conducted in 1975.

 


Justification for classification or non-classification

According to the CLP Regulation (EC n. 1272/2008) acute toxicity means those adverse effects occurring following oral or dermal administration of a single dose of a substance or a mixture, or an inhalation exposure of 4 hours.

The LC50 value for the oral administration is higher then 2000 mg/kg bw (LD50 > 5000 mg/kg bw) that is the trigger value for the acute oral toxicity classification.

Based on the data above, the substance is not classified for acute oral toxicity.