Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: no data
Principles of method if other than guideline:
no data
GLP compliance:
no
Test type:
acute toxic class method

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
mouse

Administration / exposure

Route of administration:
oral: feed
Doses:
9 g/m2 mice
30 g/m2 rats
100 g/m2 dogs

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
ca. 3 000 mg/kg bw
Based on:
not specified

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Acute and Local Toxicity – Significant lethality was observed in mice after a single oral dose of 9 g/m2. No evidence of lethality was observed in rats or dogs treated with doses of 30 and 100 g/m2, respectively. No specific diagnostic signs were observed in rodents. At these doses the only signs seen in dogs were emesis and mucoid stools2. Oral LD50 values in the dog, mouse and rat models were >5000, 3000 and 4438 mg/kg, respectively1.
Executive summary:

Acute and Local Toxicity – Significant lethality was observed in mice after a single oral dose of 9 g/m2. No evidence of lethality was observed in rats or dogs treated with doses of 30 and 100 g/m2, respectively. No specific diagnostic signs were observed in rodents. At these doses the only signs seen in dogs were emesis and mucoid stools2. Oral LD50 values in the dog, mouse and rat models were >5000, 3000 and 4438 mg/kg, respectively1.