Registration Dossier

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012-01-20 - 2012-04-05
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: OECD Guideline 439
Deviations:
no
Qualifier:
according to
Guideline:
other: EU Method B46
Deviations:
no
Principles of method if other than guideline:
- Commission Regulation (EC) No. 761/2009, Method B.46, adopted 23. July 2009: “In Vitro Skin Irritation: Reconstructed human epidermis model test”
- OECD Guideline for the Testing of Chemicals, Version 439, 22. July 2010, “In Vitro Skin Irritation: Reconstructed Human Epidermis (RhE) Test Method”
- ECVAM international validation study on in vitro tests for acute skin irritation: Report on the validity of the EPISKIN and EpiDerm assays and on the Skin Integrity Function Test (Altern Lab Anim. 2007 Dec; 35 (6): 559-601).
- Protocol for IN VITRO EpiDerm™ SKIN IRRITATION TEST (EPI-200-SIT), Rev. 3/23/2009, MatTek Corporation, Ashland, MA 01721, USA
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): (1R)-1-[(4R,4aR,8aS)-2,6-bis(4-chlorophenyl)tetrahydro[1,3]dioxino[5,4-d][1,3]dioxin-4-yl]ethane-1,2-diol
- Physical state: solid (white powder)
- Expiration date of the lot/batch: December 2012
- Storage condition of test material: Room Temperature: (20 ± 5°C); Keep away from humidity

In vitro test system

Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Vehicle:
other: serum-free DMEM medium
Details on test system:
TEST SITE
- % coverage: 100 %

REMOVAL OF TEST SUBSTANCE
- Washing (if done): DPBS-Buffer
- Time after start of exposure: 35 min.. 60 min

SCORING SYSTEM: formazan production is calculated as % photometric absorption compared with the mean of the negative control
Control samples:
not required
Amount/concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
13.4 mg (tissue 1)
22.9 mg (tissue 2)
24.3 mg (tissue 3)

VEHICLE
- Lot/batch no. (if required): 030112TMC
Duration of treatment / exposure:
1h
Duration of post-treatment incubation (if applicable):
35 - 60 min

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
other: % Formazan production
Value:
135.1
Remarks on result:
other: threshold for irritation (>50% of negative control = non-irritant)

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item (1R)-1-[(4R,4aR,8aS)-2,6-bis(4-chlorophenyl)tetrahydro[1,3]dioxino[5,4-d][1,3]dioxin-4-yl]ethane-1,2-diol showed no skin irritation potential [values are well above the treshold for irritation potential (50%)].