Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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:
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. Three-dimensional human skin model,
Cell type:
other: n.a. Three-dimensional human skin model,
Cell source:
other: n.a. Three-dimensional human skin model,
Source strain:
not specified
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
Three Minute Exposure Period
Value:
98
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:
104
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, 2,2'-ethylenedithiodiethanol, 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:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
Deviations:
no
GLP compliance:
yes
Species:
other: in vitro - Bovine
Strain:
not specified
Vehicle:
other: 20% w/v solution in 0.9% sodium chloride solution
Irritation parameter:
cornea opacity score
Run / experiment:
1
Value:
27.3
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Irritation parameter:
other: Corneal Permeability
Run / experiment:
1
Value:
1.491
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Irritation parameter:
in vitro irritation score
Run / experiment:
1
Value:
49.71
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Interpretation of results:
Category 2B (mildly irritating to eyes) based on GHS criteria
Conclusions:
It was concluded that 2,2'-ethylenedithiodiethanol, produced an IVIS score of 49.71
and no prediction can be made in respect of its potential to cause eye irritation. It is
noted that the IVIS is at the higher end of the no prediction (>3 - ≤55) range.,

based on the value of ivis and precautionary principle the substance is classified as Eye irritation cat. 2b
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