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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

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 (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
tert-butyl 2-[(4R,6R)-6-{2-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-(propan-2-yl)-1H-pyrrol-1-yl]ethyl}-2,2-dimethyl-1,3-dioxan-4-yl]acetate
EC Number:
700-258-0
Cas Number:
125971-95-1
Molecular formula:
C40H47FN2O5
IUPAC Name:
tert-butyl 2-[(4R,6R)-6-{2-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-(propan-2-yl)-1H-pyrrol-1-yl]ethyl}-2,2-dimethyl-1,3-dioxan-4-yl]acetate

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: TOXICOOP LTD.
- Age at study initiation: 7 weeks old
- Weight at study initiation: 216 - 262 g
- Fasting period before study: 24 hours
- Housing: 3 animas/cage type MAKROLON II; laboratory bedding
- Diet (e.g. ad libitum): ad libitum (exept after test item administration for 3 hours)
- Water (e.g. ad libitum): tap water ad libitum in MAKROLON type drinking bottles
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 -24.9 ºC
- Humidity (%): 32.8-65.8 %
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 1 % aquesous MC (methylcellulose)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0.5 g/ 5ml and 3 g/30 ml
- Amount of vehicle (if gavage): 20 ml/kg bw

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw
Doses:
200 mg/kg bw and 2000 mg/kg bw
No. of animals per sex per dose:
3 male /3 female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation: 6 hours after the treatment, and thereafter twice a day.
weighing: before treatment (1st day), on the 8th day, on the 14th day
- Necropsy of survivors performed: yes/no yes (macroscopic)

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
no mortality
Clinical signs:
other: no clinical signs

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU