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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:
2018
Report date:
2018

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)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of sodium methyl sulphate and 1-methylpyridinio-3-carboxylate
EC Number:
947-816-1
Cas Number:
00-00-0
Molecular formula:
previous identifier no longer suitable
IUPAC Name:
Reaction mass of sodium methyl sulphate and 1-methylpyridinio-3-carboxylate
Test material form:
liquid

Test animals / tissue source

Species:
other: bovine
Strain:
not specified

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
yes, concurrent negative control

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
in vitro irritation score
Run / experiment:
mean
Value:
30.38
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
not determinable because of methodological limitations
Irritation parameter:
other: Opacity
Run / experiment:
mean
Value:
30
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
not determinable because of methodological limitations
Irritation parameter:
other: Permeability
Run / experiment:
mean
Value:
0.025
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
not determinable because of methodological limitations

Applicant's summary and conclusion

Interpretation of results:
Category 2B (mildly irritating to eyes) based on GHS criteria
Conclusions:
It was concluded that Reaction Mass of Sodium Methyl Sulphate and
1-Methylpyridinio-3-carboxylate, produced an IVIS score of 30.38 and no prediction
can be made in respect of its potential to cause eye irritation.

Classification as Rye Irr. 2 according to precaution principle.

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