Registration Dossier

Diss Factsheets

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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Qualifier:
according to guideline
Guideline:
other: 870.1000 "Acute toxicity testing background"
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method

Test material

Constituent 1
Chemical structure
Reference substance name:
not available
Molecular formula:
C12 H16 Cl NO2 HCl
IUPAC Name:
not available
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Specific details on test material used for the study:
2-(ter-butylamino)-1-(3-chloro-4-hydroxyphenyl)ethanone HCl

Test animals

Species:
rat
Strain:
Wistar
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
physiological saline
Doses:
2000mg/kg
No. of animals per sex per dose:
3 rats for step (2 steps)

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
>= 2 000 - <= 5 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality
Clinical signs:
animal 1- step 1: 20, 30, 45, 60 as well as 80 min post-dose: slight reduced spontaneous activity, apathy. 1 day post-dose: no signs of toxicity.animal 2 and 3 - step 1: 30, 60 as well as 120 min post-dose: apathy. 1 day post-dose: no signs of toxicity.No other treatment related effects observed in any animals.
Gross pathology:
No treatment related effects observed in any animals.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The product showed slight oral toxic characteristicsAccording to GHS the substance was classified into Category 5 (LD50 cut-off: >2000 to 5000 mg/kg bw)