Registration Dossier

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Remarks:
a skin corrosion test was included in the test design
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP- and guideline compliant

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Qualifier:
according to guideline
Guideline:
other: OECD 431 Commission Regulation (EC) No 440/2008 OECD Draft for corrosion test
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
2,5-Furandione, dihydro-, mono-C15-20-alkenyl derivs.
EC Number:
272-221-2
EC Name:
2,5-Furandione, dihydro-, mono-C15-20-alkenyl derivs.
Cas Number:
68784-12-3
Molecular formula:
Due to a mixture of numerous isomers a specific molecular formular cannot be provided ( UVCB-substance) .
IUPAC Name:
2,5-Furandione, dihydro-, mono-C15-20-alkenyl derivs.
Test material form:
liquid: viscous
Details on test material:
- Name of test material (as cited in study report): ASA
- Substance type: organic
- Physical state: Yellowish clear liquid
- Analytical purity: 97.1%
- Lot/batch No.: 5500001727
- Stability under test conditions: stable
- Storage condition of test material: RT

In vitro test system

Test system:
human skin model
Cell type:
non-transformed keratinocytes

Test system

Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µL (corrosion test), 30 µL (irritation test)
- Concentration (if solution): 100%
Duration of treatment / exposure:
1 hour
Observation period:
2 days
Number of animals:
not applicable

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
corrosion 3 min exposure
Value:
101
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Remarks:
no indication of corrosion
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
corrosion 1 hour exposure
Value:
86
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Remarks:
no indication of corrosion
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
irritation 1 hour exposure
Value:
110
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation

Any other information on results incl. tables

1. Corrosion test


 



























































































             Exposure: 3 min          Exposure: 1 hour
 Test article     tissue 1   tissue 2 KC mean
 NC  mean OD570 1.7627 1.7522 0.2267 1.7574 1.7657 1.6962 0.1762 1.7309
  viability[% of NC] 100.3 99.7 - 100 102.0 98.0 - 100
 ASA  mean OD570 1.8112 1.7222 0.2012 1.7667 1.3892 1.6027 0.1867 1.4959
  viability[% of NC] 103.1 98.0 - 101 80.3 92.6 - 86
 PC  mean OD570 0.4438 0.3498 - 0.39680.1597   0.1867 - 0.1732
  viability[% of NC] 25.3 19.9 - 23 9.2 10.8 - 10

 


Due to the ability of the test substance to reduce MTT directly, a KC was applied in parallel.


However, the result of the KC did not indicate an increased MTT reduction (difference to KC


of NC is not greater than 0.1; see section 3.6.4). Thus the KC was not used for viability


calculation.


 


2. Irritation test


 




































































 Test article  tissue 1 tissue 2 tissue 3 mean SD
 NC  mean OD570 1.6795 1.6125 1.5725 1.6215 
   viability[% of NC] 103.6 99.4 97.0 100 3.33
 ASA mean OD570 1.7575 1.7070 1.8980 1.7875 
    viability[% of NC] 108.4 105.3 117.1 110 6.10
 PC  mean OD570 0.1165 0.13200.1215  0.1233 
   viability[% of NC] 7.2 8.1 7.5 8 0.49

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
substance is not corrosive and not irritating to the skin
Conclusions:
Based on the observed results and applying the evaluation criteria it is concluded, that substance does not show a skin irritation potential in the EpiDerm ™ skin corrosion/irritation test under the test conditions chosen.