Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study according EU/OECD guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report Date:
2014

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
(2001)
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: polyethylene glycol (400)
Doses:
2000 mg/kg body weight (bw)
No. of animals per sex per dose:
six female rats
Control animals:
no

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Remarks on result:
other: No mortalities occurred at a dose level of 2000 mg/kg bw, therefore, a LD50 >5000 mg/kg bw was derived according to OECD TG 423

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
A dose of 2000 mg/kg body weight was tolerated by female rats without mortalities, effects on weight development and gross pathological findings. Clinical observations revealed decreased activity (1/6) and hunched back (5/6). All animals were symptom free from Day 3 onwards. The test material is nontoxic after acute oral administration at the dose level of 2000 mg/kg bw. Since no mortalities occurred at a dose level of 2000 mg/kg bw, a LD50 value >5000 mg/kg bw was derived according to OECD TG 423.