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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

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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:
guideline study

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Isopropyl nitrite
EC Number:
208-779-0
EC Name:
Isopropyl nitrite
Cas Number:
541-42-4
Molecular formula:
C3H7NO2
IUPAC Name:
propan-2-yl nitrite

In vitro test system

Test system:
human skin model
Remarks:
SkinEthic RHE® model
Source species:
human
Cell type:
non-transformed keratinocytes
Vehicle:
unchanged (no vehicle)
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
16 uL
Duration of treatment / exposure:
42 minutes
Duration of post-treatment incubation (if applicable):
41 hours and 40 minutes
Number of replicates:
3 living human skin models

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
mean
Value:
ca. 1
Negative controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
The mean percent viability of the treated tissues was 1.0%, versus 1.5% in the positive control (5% Sodium Dodecyl Sulfate).

Applicant's summary and conclusion

Interpretation of results:
other: the test item ISOPROPYL NITRITE has to be classified in Category 2 “Irritating to skin” or in Category 1 “Corrosive”
Conclusions:
In accordance with the Regulation EC No. 1272/2008 and in absence of information on skin corrosion, the test item ISOPROPYL NITRITE has to be classified in Category 2 “Irritating to skin” or in Category 1 “Corrosive”. The hazard statement “H315: Causes skin irritation” with the signal word “Warning” or “H314: Causes severe skin burns and eye damage” with the signal word “Danger” are required.