Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
27-Aug-2014 to 29-Aug-2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: EU method B.40 BIS: "In Vitro Skin Corrosion: Human Skin Model Test
Deviations:
no
Qualifier:
according to
Guideline:
other: OECD Guideline, no. 431: In Vitro Skin Corrosion: Human Skin Model Test
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): HEDTA-H3
- Substance type: White powder
- Physical state: Powder
- Storage condition of test material: At room temperature in the dark



Test system

Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 mg of the test substance was applied undiluted ( with 25 µl Milli-Q water to ensure close contactto the tissue)

NEGATIVE CONTOL:
- Amount(s) applied (volume or weight with unit): 50 µl Milli-Q water

POSITIVE CONTROL
- Amount(s) applied (volume or weight with unit): 50 µl KOH
- Concentration (if solution): 8 N
Duration of treatment / exposure:
Exposure:3 minutes and 1 hour
Post incubation period: 42 hours
Details on study design:
TEST SITE
- Area of exposure: human skin model
- % coverage: 0.6 cm2

REMOVAL OF TEST SUBSTANCE
- Washing (if done): phosphate buffered saline
- Time after start of exposure: 3 minutes and 1 hour

POST INCUBATION PERIOD
- 42 hours

SCORING SYSTEM:
- After treatment the medium was replaced by 300 µl MTT-medium and tissues were incubated for
3 hours at 37°C in air containing 5% CO2. After incubation the tissues were washed with PBS and formazan was extracted with 2 ml isopropanol (MatTek corporation) over night at room temperature. The amount of extracted formazan was determined spectrophotometrically at 540 nm

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
other:
Value:
86
Remarks on result:
other:
Remarks:
Basis: other: percentage of control. Time point: 3 minutes. (migrated information)
Irritation / corrosion parameter:
other:
Value:
59
Remarks on result:
other:
Remarks:
Basis: other: percentage of control. Time point: 1 hour. (migrated information)

Any other information on results incl. tables

The inter-tissue variability in viability between two tissues and the maximum difference in percentage between the mean viability of two tissues and one of the two tissues treated with HEDTA-H3 were above the acceptability criteria (up to 44 and 22%, respectively at the 1 hour treatment period). Since both viabilities were above 15% the outcome of both tissues wasclearly negative. Therefore this deviation has no influence on the study integrity

Applicant's summary and conclusion

Interpretation of results:
other: not corrosive
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
HEDTA-H3 is not corrosive in the in vitro skin corrosion test.

Executive summary:

Although the inter-tissue variability in viability between two tissues and the maximum difference in percentage between the mean viability of two tissues and one of the two tissues treated with HEDTA-H3 were above the acceptability criteria (up to 44 and 22%, respectively at the 1 hour treatment period), all individual results obtained were clearly negative. Consequently, this deviation has no impact on the outcome of the study.

 

Skin corrosion is expressed as the remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained after 3-minute and 1-hour treatments with HEDTA-H3 compared to the negative control tissues was 86% and 59%, respectively. Because the mean relative tissue viability for HEDTA-H3 was not below 50% after the 3-minute treatment and not below 15% after the 1-hour treatment HEDTA-H3 is considered to be not corrosive.