Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 2012-09-25 to 2012-09-28
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

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:
1-(5'-((5S)-5-(3,5-Dichloro-4-fluorophenyl)-5-(trifluoromethyl)-4,5-dihydroisoxazol-3-yl)-3'-H-spiro(azetidine-3,1'-(2)benzofuran)-1-yl)-2-(methylsulfonyl)ethanone
Cas Number:
1398609-39-6
Molecular formula:
C23H18Cl2F4N2O5S
IUPAC Name:
1-(5'-((5S)-5-(3,5-Dichloro-4-fluorophenyl)-5-(trifluoromethyl)-4,5-dihydroisoxazol-3-yl)-3'-H-spiro(azetidine-3,1'-(2)benzofuran)-1-yl)-2-(methylsulfonyl)ethanone
Specific details on test material used for the study:
Lot No.: PF-06450567-00-0022
Purity: Not provided

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Rich-Glo II, Inc; Wills Point, TX
- Age at study initiation: ca. 3 months
- Weight at study initiation: 2.229-2.824 kg
- Housing: Suspended, wire bottom, stainless steel, 1 per cage
- Diet: PMI Feeds, ca. 8 oz. daily
- Water: Municipal water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
- Humidity (%): 49-89
- Air changes (per hr): 10-12 air changes/hour
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle

IN-LIFE DATES: From: 25 Sep 12 To: 28 Sep 12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
500 mg of test item moistened with 0.5 mL of DI water
Duration of treatment / exposure:
4 hous
Observation period:
72 hours
Number of animals:
1 male, 2 females (nulliparous & non-pregnant)
Details on study design:
TEST ITEM ADMINISTRATION
On Day 0, 500 mg of test item moistened with 0.5 mL of DI water was applied to each test site and covered with a 4 ply, 2.5 x 2.5 cm surgical gauze patch. Each patch was secured in place with a strip of non-irritating adhesive tape. The entire trunk of each animal was loosely wrapped with a semi-permeable dressing (orthopedic stockinette) which was secured on both edges with strips of tape to retard evaporation of volatile substances and to prevent possible ingestion of the test item.

REMOVAL OF TEST SUBSTANCE
- Washing: The test sites were gently washed with room temperature tap water and a clean cloth to remove as much residual test item as possible.
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
The test sites were observed for erythema and edema formation, and any other dermal effects at 1, 24, 48 and 72 hours after unwrap.

SCORING SYSTEM:
- Method of calculation: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritant / corrosive response data:
Erythema and edema were not observed at any time throughout the study. No other dermal effects were observed during the study.

Any other information on results incl. tables

Individual dermal irritation scores:














































Animal No.



Erythema score



Edema score



24 h



48 h



72 h



24 h



48 h



72 h



1



0



0



0



0



0



0



2



0



0



0



0



0



0



3



0



0



0



0



0



0


Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The primary irritation index of 0.0 out of a possible 8.0 was obtained from the observations at 1, 24, 48 and 72 hours, and was used to give test item a descriptive rating of non-irritating.
Executive summary:

A primary dermal irritation study was conducted on three albino rabbits using test item in accordance with OECD 404.


There was one intact test site per animal. Each test site was treated with 500 mg of test item moistened with 0.5 mL of DI water and covered with a semi-permeable dressing. The test item was maintained in contact with the skin for 4 hours. Observations for dermal irritation and defects were made at 1, 24, 48 and 72 hours after removal of the dressings.


The erythema and edema scores for each animal are all 0 for 24, 48, and 72 h observations.


The test item is rated non-irritating.