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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August 2020
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2020
Report date:
2020

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Water
EC Number:
231-791-2
EC Name:
Water
Cas Number:
7732-18-5
Molecular formula:
H2O
IUPAC Name:
Aqua; Water
Constituent 2
Chemical structure
Reference substance name:
Fytic acid
EC Number:
201-506-6
EC Name:
Fytic acid
Cas Number:
83-86-3
Molecular formula:
C6H18O24P6
IUPAC Name:
fytic acid
Specific details on test material used for the study:
Biosil PA diluted at 20%

Test animals / tissue source

Species:
human

Test system

Vehicle:
water
Controls:
yes

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
percent tissue viability 
Run / experiment:
Run 3 : 4 hours
Value:
ca. 6
Vehicle controls validity:
valid
Positive controls validity:
valid
Remarks on result:
positive indication of irritation
Irritation parameter:
percent tissue viability 
Run / experiment:
Run 2 : 1 hour
Value:
ca. 7
Vehicle controls validity:
valid
Positive controls validity:
valid
Remarks on result:
positive indication of irritation
Irritation parameter:
percent tissue viability 
Run / experiment:
Run 1 : 20 minutes
Value:
ca. 27
Vehicle controls validity:
valid
Positive controls validity:
valid
Remarks on result:
positive indication of irritation

Applicant's summary and conclusion

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