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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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:
2021
Report date:
2021

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
GLP compliance:
yes (incl. QA statement)

Test material

1
Chemical structure
Reference substance name:
DL-2-aminopropan-1-ol
EC Number:
228-207-3
EC Name:
DL-2-aminopropan-1-ol
Cas Number:
6168-72-5
Molecular formula:
C3H9NO
IUPAC Name:
2-aminopropan-1-ol

Test animals / tissue source

Species:
cattle
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Bovine corneas, obtained as a byproduct from freshly slaughtered animals, were mounted in special holders and exposed to the test article.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
without dilution (neat).

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
histopathological observations
Run / experiment:
3-minute exposure
Remarks on result:
positive indication of irritation
Remarks:
3-minute exposure to the test article produced damage to the epithelium, as noted by the destruction of squamous and upper wing cell nuclei, as well as damage noted in basal cell nuclei. Stromal swelling was noted in the upper stroma to mid stroma (marked swelling and keratocyte changes), and extended into the lower stroma (slight to moderate swelling). The endothelium was damaged or lost in many fields. Based on the depth of injury model by Jester and Maurer (2002), the histology showed a full thickness damage to the cornea, which is consistent with a severe ocular injury.
Irritation parameter:
cornea opacity score
Run / experiment:
10-minute exposure
Value:
50
Negative controls validity:
valid
Positive controls validity:
valid
Irritation parameter:
cornea opacity score
Run / experiment:
3-minute exposure
Value:
36.3
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: pH=8
Irritation parameter:
in vitro irritation score
Run / experiment:
3-minute exposure
Value:
45.2
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: pH=8
Irritation parameter:
in vitro irritation score
Run / experiment:
10-minute exposure
Value:
100.4
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: pH=8

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Executive summary:

The In Vitro Score of the test article was 45.2 for the 3 minute exposure time and 100.4 for the 10 minute exposure. According to the prediction model presented in OECD TG 437, the test article at the 10 minute exposure time was predicted to be a GHS Category 1 (Severe/Corrosive) eye irritant. Concerning the 3-minutes exposure, severe eye damage was confirmed by histology evaluation.