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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Skin irritation / corrosion, Read across from Sarolaner step 2:


The in vitro skin corrosion and irritation studies were performed in accordance with OECD 431 and 439. The test item is determined as not corrosive and not irritating to skin.


 


Eye irritation, Read across from Sarolaner step 2:


The eye damage of the test item was tested through topical application for approximately 240 minutes in an isolated bovine cornea using the Bovine Corneal Opacity and Permeability test (BCOP test) according to OECD 437.


Since the test item induced an IVIS ≤ 3 in 5 out of 6 corneas, no classification is required for eye irritation or serious eye damage.

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:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read across based on structural similarity
Justification for type of information:
Read across from Sarolaner step 2
Reason / purpose for cross-reference:
read-across source
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
1
Value:
100
Negative controls validity:
valid
Positive controls validity:
valid
Interpretation of results:
GHS criteria not met
Conclusions:
The test item is not irritant to skin.
Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read across based on structural similarity
Justification for type of information:
Read across from Sarolaner step 2
Reason / purpose for cross-reference:
read-across source
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
1-hour exposure
Value:
99
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
3-minutes exposure
Value:
91
Negative controls validity:
valid
Positive controls validity:
valid
Interpretation of results:
GHS criteria not met
Conclusions:
The test item is not corrosive to skin.
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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read across based on structural similarity
Justification for type of information:
Read across from Sarolaner step 2
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
in vitro irritation score
Run / experiment:
Second experiment
Value:
>= -2.5 - <= -0.9
Negative controls validity:
valid
Positive controls validity:
valid
Interpretation of results:
GHS criteria not met
Conclusions:
Since the test item induced an IVIS ≤ 3 in 5 out of 6 corneas, no classification is required for eye irritation or serious eye damage.
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

Skin irritation / corrosion:


In vitro skin corrosion and irritation, read across data, OECD 431 and 439: not corrosive, not irritating.


According to Regulation (EC) No 1272/2008, table 3.2.2, this substance should not be classified for this endpoint.


 


Eye irritation:


In vitro eye irritation, read across data, OECD 437: not irritating.


According to Regulation (EC) No 1272/2008, table 3.3.2, this substance should not be classified for this endpoint.