Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
14-Apr-2014 to 18-Apr-2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report Date:
2014

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: flakes
Details on test material:
- Name of test material (as cited in study report): Succinic anhydride- Substance type: White flakes- Physical state: Solid- Storage condition of test material: In refrigerator (2-8˚C) 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 waterPOSITIVE 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 hourPost incubation period: 42 hours
Details on study design:
TEST SITE- Area of exposure: human skin model- % coverage: 0.6 cm2REMOVAL OF TEST SUBSTANCE- Washing (if done): phosphate buffered saline- Time after start of exposure: 3 minutes and 1 hourPOST INCUBATION PERIOD- 42 hoursSCORING 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:
96
Remarks on result:
other:
Remarks:
Basis: other: percentage of control. Time point: 3 minutes. (migrated information)
Irritation / corrosion parameter:
other:
Value:
12
Remarks on result:
other:
Remarks:
Basis: other: percentage of control. Time point: 1 hour. (migrated information)

Applicant's summary and conclusion

Interpretation of results:
Category 1 (corrosive) based on GHS criteria
Conclusions:
Succinic anhydride is corrosive in the in vitro skin corrosion test
Executive summary:

The test substance was tested for skin corrosion potential in an in vitro skin corrosion study (OECD 431).The positive control had a mean relative tissue viability of 9% after 3 minutes exposure. The absolute mean OD540 (optical density at 540 nm) of the negative control tissues was within the laboratory historical control data range. The maximum inter-tissue variability in viability between two tissues treated identically was less than 23% and the maximum difference in percentage between the mean viability of two tissues and one of the two tissues was less than 13%, indicating that the test system functioned properly.

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 Succinic anhydride compared to the negative control tissues was 96% and 12%, respectively. Because the mean relative tissue viability for Succinic anhydride was below 15% after the 1-hour treatment, it is considered to be corrosive.