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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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:
2016
Report date:
2016

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:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
acute toxic class method

Test material

Constituent 1
Chemical structure
Reference substance name:
2-(4-{1-hydroxy-4-[4-(hydroxydiphenylmethyl)piperidin-1-yl]butyl}phenyl)-2-methylpropanenitrile
EC Number:
811-752-1
Cas Number:
169032-19-3
Molecular formula:
C32 H38 N2 O2
IUPAC Name:
2-(4-{1-hydroxy-4-[4-(hydroxydiphenylmethyl)piperidin-1-yl]butyl}phenyl)-2-methylpropanenitrile

Test animals

Species:
rat
Strain:
other: Crl:WI(Han)
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
methylcellulose
Doses:
2000 mg/kg
No. of animals per sex per dose:
Two groups of 3 female rats were given the test item at the dose 2000 mg/kg.
Control animals:
no

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
One animal was found dead on Day 13. There were no other deaths.
Clinical signs:
other: Clinical signs noted in one animal were piloerection, decreased breating rate, anogenital soiling and areas of red/brown staining around the snout. These clinical signs developed from Day 4 and lasted up to Day 12. The animal was found dead on Day 13. No
Gross pathology:
No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The test article 2-[4-[1-hydroxy-4-[4-[hydroxy(diphenyl)methyl]-1-piperidyl]butyl]phenyl]-2-methyl-propanenitrile was classified as Category 5 in respect of its acute oral toxicity according to the GHS of Classification and Labelling of Chemicals.