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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
skin irritation: in vivo
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 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

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:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Ferenc Sandor breeder , Kartal, Hungary
- Age at study initiation: adult albino rabbits
- Weight at study initiation: 3147-3283 g
at study termination: 3230-3288 g
- Housing: individually in metal cages.
- Diet (e.g. ad libitum): ad libitum, UNIPLUS standard diet (AGRIBRANDS EUROPE)
- Water (e.g. ad libitum): ad libitum, potable water from automatic self-service water system
- Acclimation period: 20 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 20 %
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of each animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g test item, in pure state, in a single dose

VEHICLE
No vehicle was applied
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: appr. 6 cm2
- Type of wrap if used: sterile gauze patch fixed with adhesive hypoallergenic plaster

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with body temperature water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize (1959)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
for each animal
Time point:
other: 1 h, 24 h, 48 h, 72 h
Score:
0
Max. score:
0
Reversibility:
other: no signs
Irritation parameter:
edema score
Basis:
mean
Remarks:
for each animal
Time point:
other: 1 h, 24 h, 48 h, 72 h
Score:
0
Max. score:
0
Reversibility:
other: no signs
Irritant / corrosive response data:
No primary irritation symtoms, like erythema and edema, or other signs occured during the observation period.

Applicant's summary and conclusion

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