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Description of key information

Guideline study shows that MDI-Urone is of very low toxicity

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:
unknown
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Fischer 344
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
methylcellulose
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 5000 mg MDI-Urone
- Amount of vehicle (if gavage): 10 ml/kg body weight
- Justification for choice of vehicle:The vehicle was chosen due to its non-toxic characteristics.
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
3 males and 3 females
Control animals:
no
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 5 000 mg/kg bw
Based on:
test mat.
Mortality:
As none of the animals died the LD0 is >5000 mg/kg body weight.
Clinical signs:
Signs of toxicity related to dose levels:
Lethargy, ataxia, cool body, congestion, lacrimation, dried
red material around snout, anorexia, emaciation, decreased
defecation and scruffy coat
Gross pathology:
Effects on organs:
No treatment-related changes.
Other findings:
no other findings
Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 of MDI-Urone was established to be > 5000 mg/kg body weight. As none of the animals died the corresponding LD0 is > 5000 mg/kg bw. Thus, MDI-Urone is practically nontoxic.
Executive summary:

In an acute oral toxicity study according to OECD 423, groups of 3 male and 3 female rats were given a single oral dose of 5000 mg/kg body weight MDI-Urone and were observed for 14 days.

Considering the reported data of this toxicity test it can be stated that the test item MDI-Urone has no acute toxic characteristics.

According to the results obtained the LD50 was determined to be > 5000 mg/kg bw.

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

Additional information

Justification for classification or non-classification

Guideline study shows that MDI-Urone is of very low toxicity