Registration Dossier

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: according to guideline and GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD TG 431 and EC B40
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: amber viscous liquid
Details on test material:
Content: 100 & Additin E459
Main Compound: Triethyleneglycol dimaleate (86 %)
Byproduct: triethyleneglycol monomaleate (9 %)

Test animals

Species:
other: in vitro
Strain:
other: in vitro
Details on test animals and environmental conditions:
in vitro test

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: in vitro test: negative control 0.9 % NaCl
Amount / concentration applied:
25 mg
Duration of treatment / exposure:
3 min and 60 min (3 inserts per period)
Observation period:
after the exposure period of 3 min or 60 min the inserts were washed carefully in PBS and MTT reduction assay was performed
Number of animals:
in vitro test
Details on study design:
The experiment was carried out in accordance with the OECD 431 guideline as well as with an EC guideline (amending Council Directtive 67/548/EEC B 40 skin corrosion) using commercially available reconstructed human epidermis(RHS) model EST-1000. Undiluted test substance was applied topically to the RHS model: 50 µl of the test item per insert ( RT: three inserts per period of incubation). 0.9 % NaCl (50µl) treated epidermal models were used as negative controls (determination in triplicate). After the exposure period of 3 min or 60 min the inserts were washed carefully in PBS. Afterwards the MTT reduction assay was performed to measure the cell viability.

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
other:
Value:
2.68
Remarks on result:
other:
Remarks:
Basis: other: negative control. Time point: 3 min. Max. score: 2.68. Reversibility: no data. Remarks: Optical Density (OD): 2.68 = 100 % viability. (migrated information)
Irritation / corrosion parameter:
other:
Value:
1.27
Remarks on result:
other:
Remarks:
Basis: other: test item. Time point: 3 min. Max. score: 2.68. Reversibility: no data. Remarks: OD mean 2.68 = 100 % viability; OD mean 1.27 = 47.39 % viability. (migrated information)
Irritation / corrosion parameter:
other:
Value:
2.59
Remarks on result:
other:
Remarks:
Basis: other: negative control. Time point: 60 min . Max. score: 2.59. Reversibility: no data. Remarks: Optical Density (OD):2.59 = 100 % viability; . (migrated information)
Irritation / corrosion parameter:
other:
Value:
0.96
Remarks on result:
other:
Remarks:
Basis: other: test item. Time point: 60 min. Max. score: 2.59. Reversibility: no data. Remarks: OD mean 2.59 = 100 % viability; OD mean 0.96= 37.14 % viability. (migrated information)

In vivo

Irritant / corrosive response data:
Compound Cell viability after 3 min. [%] Cell viability after 60 min. [%] Classification

Additin E 459 47.39 37.14 Corrosive
Negative control 100.00 100.00 Negative Control

Any other information on results incl. tables

 Sample No  Test item  Time [min.]  OD mean*  StdDev  Viability %
1 -3   control NaCl 0.9%  60  2.59  0.09  100
 4 -6  test item  60  0.96  0.21  37.14
 10 -12  control NaCl 0.9%  3  2.68  0.02  100
 16 -18 test item  3  1.27  0.12  47.39

* 6 values

Applicant's summary and conclusion

Interpretation of results:
other: corrosive
Executive summary:

An in-vitro study for predicting non-specific, corrosive potential of Additin E 459 by using reconstructed human skin (RHS) EST-1000 was performed in accordance with OECD TG 431 and with EC guideline (amending Concil Direcrive 67/548/EEC B 40 Skin corrosion). Additin E 459 was tested undiluted (25 mg per insert, plus 50 µl 0.9 % NaCl to moisten and to ensure good contact with the skin). An incubation time of 3 min or of 60 min was used to determine time related toxic effects. After incubation the MTT reduction assay was performed to measure the cell viability which was 47 % and 37 % , respectively. Thus, the results show that a corrosive property of the test item was determined by the assay used.