Registration Dossier

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity
Type:
impurity
Test material form:
solid: bulk

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female

Administration / exposure

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

Results and discussion

Effect levels
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

Applicant's summary and conclusion

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.