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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Remarks:
eye corrosion
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 438 (Isolated Chicken Eye Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU method B.48 (Isolated chicken eye test method for identifying occular corrosives and severe irritants)
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

Test animals / tissue source

Species:
chicken

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
30 uL
Duration of treatment / exposure:
10 seconds
Number of animals or in vitro replicates:
3 enucleated chicken eyes

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Run / experiment:
mean
Value:
ca. 3
Negative controls validity:
valid
Positive controls validity:
valid
Irritation parameter:
fluorescein retention score
Run / experiment:
mean
Value:
ca. 3
Negative controls validity:
valid
Positive controls validity:
valid
Irritation parameter:
percent corneal swelling
Run / experiment:
mean
Value:
ca. 47
Negative controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
The ocular reactions observed in eyes treated with the test item were:
- maximal mean score of corneal opacity: 3.0, corresponding to ICE class IV;
- mean score of fluorescein retention: 3.0, corresponding to ICE class IV;
- maximal mean corneal swelling: 47%, corresponding to ICE class IV.
The combination of the three endpoints for the test ISOPROPYL NITRITE was 3 x IV.

The combination of the three endpoints for the positive control, 5% Benzalkonium chloride, was 3 x IV. Therefore, the positive control is classified as “Corrosive/Severe Irritant”, as expected.
The combination of the three endpoints for the negative control, physiological saline, was 3 x I. Therefore, the negative control is classified as “No Category”, as expected.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
In accordance with the Regulation (EC) No. 1272/2008, the test item ISOPROPYL NITRITE has to be classified in Category 1 “Irreversible effects on the eye”.
The signal word “Danger” and hazard statement H318 “Causes serious eye damage” are required.