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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
eye 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 405 (Acute Eye 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 / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Source: Ferenc Sandor breeder , Kartal, Hungary
- Age at study initiation: adult albino male rabbits
- Weight at study initiation: 2944-3277 g
at study termination: 3110-3366 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: 15 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70 %
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the contralateral eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g of test item in pure state, as a single dose
Duration of treatment / exposure:
The eyes were not rinsed after the administration of the test item.
Observation period (in vivo):
1, 24, 48, 72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
no removal

SCORING SYSTEM:
by Draize (1959) and OECD 405

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
for each animal
Time point:
other: 1 h, 24 h, 48 h, 72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: chemosis, redness, discharge
Irritation parameter:
cornea opacity 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
Remarks on result:
other: corneal alteration were not found
Irritation parameter:
iris score
Basis:
mean
Remarks:
for each animal
Time point:
other: 1 h, 24 h, 48 h, 72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: plethoric iris reacted to light
Irritant / corrosive response data:
1 hour mean irritation index: 15.67
24 hour mean irritation index: 1.33
48 hour mean irritation index: 0.00
72 hour mean irritation index: 0. 00

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information fully reversible Criteria used for interpretation of results: EU
Conclusions:
Not classified.