Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
2005

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: CrlGlxBrlHan:WI
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.5% aqueous hydroxyethylcellulose
Doses:
200 and 2000 mg/kg
No. of animals per sex per dose:
3 females / 200 mg/kg3 females / 3 males / 2000 mg/kg

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
approximate LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred following a single oral administration of 200 and 2000 mg/kg.
Clinical signs:
At 2000 mg/kg, piloerection and sedation were seen in rats of both genders from 0.5 h to8.0 h post administration at the latest. They returned to normal during the Day 1 (males atabout 6 h, females at 10 h post administration) and no further abnormal clinical signs werenoted throughout the entire 14-day observation period.
Body weight:
No effects on body weight development were noted in males and females
Gross pathology:
No gross pathological findings were noted at necropsy in females treated with 200 mg/kg,as well as in rats of both genders subsequent to administration of 2000 mg/kg

Applicant's summary and conclusion

Interpretation of results:
other: "not classified" according CLP
Conclusions:
Under the conditions of the present study, no mortality was seen in rats subsequent to oral administration of CD 616 BS at doses of 200 mg/kg and 2000 mg/kg, respectively.The approximate lethal dose (ALD) for BI 1356 BS / CD 616 BS is above 2000 mg/kg for male and female rats.