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 irritation: in vitro / ex vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reason / purpose for cross-reference:
read-across source
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
replicate a
Value:
107.2
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
replicate b
Value:
95.7
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
replicate c
Value:
93.9
Negative controls validity:
valid
Positive controls validity:
valid
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:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
cornea opacity score
Run / experiment:
replicate 1
Value:
0.333
Negative controls validity:
valid
Positive controls validity:
valid
Irritation parameter:
cornea opacity score
Run / experiment:
replicate 2
Value:
1.333
Negative controls validity:
valid
Positive controls validity:
valid
Irritation parameter:
cornea opacity score
Run / experiment:
replicate 3
Value:
1.333
Negative controls validity:
valid
Positive controls validity:
valid
Irritation parameter:
in vitro irritation score
Run / experiment:
replicate 1
Value:
0.483
Negative controls validity:
valid
Positive controls validity:
valid
Irritation parameter:
in vitro irritation score
Run / experiment:
replicate 2
Value:
1.063
Negative controls validity:
valid
Positive controls validity:
valid
Irritation parameter:
in vitro irritation score
Run / experiment:
replicate 3
Value:
1.078
Negative controls validity:
valid
Positive controls validity:
valid
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

In the in vitro skin and eye irritation studies performed with the read-across source substance WS405777 no effects were observed in the presence of the test substance. Therefore, classification of WS405777 for skin or eye irritation is not required [REGULATION (EC) 1272/2008].

The same conclusion on non-classification for skin and eye irritation can be drawn for the read-across target substance WS406663 based on the close chemical similarity between the two substances (see IUCLID Section 13 „Validity Assessment Report“ for the read-across approach).