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Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

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
Qualifier:
according to guideline
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test system:
human skin model
Source species:
other: n.a. skin model
Cell type:
other: n.a. skin model
Cell source:
other: n.a. skin model
Source strain:
other: n.a. skin model
Vehicle:
unchanged (no vehicle)
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
mean
Value:
115.4
Vehicle controls validity:
not examined
Negative controls validity:
valid
Positive controls validity:
valid
Interpretation of results:
GHS criteria not met
Conclusions:
The test article, Reaction mass of sodium methyl sulphate and 1-methylpyridinio-3-
carboxylate, was considered not to be irritant in the in vitro skin model EpiDerm™
SIT (EPI-200).
Endpoint:
skin corrosion: 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
Qualifier:
according to guideline
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
Deviations:
no
GLP compliance:
yes
Test system:
human skin model
Source species:
other: n.a., 3d model
Cell type:
other: n.a., 3d model
Cell source:
other: n.a., 3d model
Source strain:
other: n.a., 3d model
Vehicle:
unchanged (no vehicle)
Control samples:
yes, concurrent MTT non-specific colour control
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
Three Minute Exposure Period
Value:
100.2
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
One Hour Exposure Period
Value:
88.1
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Interpretation of results:
GHS criteria not met
Conclusions:
The test article, Reaction mass of sodium methyl sulphate and 1-methylpyridinio-3-
carboxylate, was considered to be non-corrosive according to the UN GHS
classification system.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
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
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
Species:
other: bovine
Strain:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
yes, concurrent negative control
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
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.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification