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Toxicological information

Skin irritation / corrosion

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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vitro test system

Test system:
human skin model
Amount/concentration applied:
The test item was applied as supplied, at the dose of 16 μL to the epidermal surface.
Duration of treatment / exposure:
During 42 minutes at room temperature.
Number of replicates:
3 living human skin models

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Value:
0.9
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Interpretation of results:
Category 1 (corrosive) based on GHS criteria
Conclusions:
In accordance with the Regulation EC No. 1272/2008 and considering the results obtained during the in vitro skin corrosion study (study No. HSMC-PH-18/0023, test item classified as corrosive 1B/1C), the test item ISOAMYL NITRITE has to be classified in Category 1 “Corrosive”. The hazard statement “H314: Causes severe skin burns and eye damage” with the signal word “Danger” is required.
Executive summary:

The aim was to evaluate the possible irritating effects of the test item ISOAMYL NITRITE after topical application on in vitro human reconstructed epidermis (SkinEthic RHE® model).

The test item ISOAMYL NITRITE was applied as supplied, at the dose of 16 μL to 3 living Reconstructed Human epidermis (SkinEthic RHE® model) during 42 minutes. The application was followed by a rinse with 25 mL of DPBS and a 41 hours and 40 minutes post-incubation period at 37°C, 5% CO2. Cell viability was then measured by enzymatic conversion of the vital dye MTT into a blue formazan salt that was quantitatively measured after extraction from tissues.

The experimental protocol was established in accordance with O.E.C.D. Test Guideline No. 439 adopted 28 July 2015 and the Test method B.46 of Council regulation No. 761/2009 dated 23 July 2009 (EU Journal L220) - ATP Council regulation No. 440/2008 of 30 May 2008 (E.U. Journal L142).

An opaque beige coloration was noted on all Reconstructed Human epidermis after the rinse.

The mean percent viability of the treated tissues was 0.9%, versus 1.5% in the positive control (5% Sodium Dodecyl Sulfate).

In accordance with the Regulation EC No. 1272/2008 and considering the results obtained during the in vitro skin corrosion study (study No. HSMC-PH-18/0023, test item classified as corrosive 1B/1C), the test item ISOAMYL NITRITE has to be classified in Category 1 “Corrosive”. The hazard statement “H314: Causes severe skin burns and eye damage” with the signal word “Danger” is required.