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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 sensitisation: in vivo (non-LLNA)
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 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test

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

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: LAB-ÁLL Bt. Budapest, Hungary
- Weight at study initiation: 362-434 g
- Housing: 2-3 animals in 42x42x19 cm macrolon cages
- Diet (e.g. ad libitum): ad libitum, PUNIPLUS standard diet for rabbits (AGRIBRAND)
- Water (e.g. ad libitum): ad libitum, potable water containing 50 mg/100 ml Ascorbic acid.
- Acclimation period: 20 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 30-70 %
- Rate of air exchange: 13-17/hour
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: methylcellulose (1%)
Concentration / amount:
75 (w/v) % in methylcellulose 1 % aqueous solution for dermal induction treatment and for the challenge treatment,
0.1 % for the intradermal treatment using Freund's complete adjuvant and physiological saline.
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: methylcellulose (1%)
Concentration / amount:
75 (w/v) % in methylcellulose 1 % aqueous solution for dermal induction treatment and for the challenge treatment,
0.1 % for the intradermal treatment using Freund's complete adjuvant and physiological saline.
No. of animals per dose:
In the range finding study: 2 animals / 2 concentrations (2 concentrations in 1 animal: one on the right side and the other on the left side)
Main study: test groups - 10 animals
control group - 5 animals
Details on study design:
10 test animals were subjected to sensitization procedures in a two stage operation, i.e. intradermal treatment and a topical application.
The test item was used in concentration of 0.1% for intradermal injections and in concentration of 75 % (w/v) for dermal sensitization treatment. Before Before the dermal exposure the test area was painted with 0.5 ml of 10% sodium lauryl sulphate in vaseline 24 h prior to the topical induction application, in order to create a local irritation.
Two weeks following the last induction exposure, a challenge dose (in concentration 75%) was administered. Challenge was performed by dermal application of the test item.
Challenge controls:
5 control guinea pigs were simultaneously exposed to vehicle during the sensitization phase and they were treated with the test item (in concentration 75 %) only in the case of challenge.

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
75 w/v %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no visible change
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 75 w/v %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no visible change.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
75 w/v %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no visible change
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 75 w/v %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no visible change.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
75 w/v %
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no visible change
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 75 w/v %. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no visible change.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
75 w/v %
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no visible change
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 75 w/v %. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no visible change.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information EU
Conclusions:
According to net percentage value of positively responded animals and to the net score value of the skin reactions, the test item
was classified as no sensitizer.