Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Skin: Read across to Sarolaner API


A skin sensitization study was conducted on 3 groups of 5 female mice to determine if test item possesses a significant potential to cause skin sensitization according to OECD 429. 


The test item produced a stimulation index of < 3 in all groups of Test animals, and is not therefore considered a sensitizer (defined as producing a positive response).


 

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (LLNA)
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 through category approach
Justification for type of information:
Read across to Sarolaner API
Reason / purpose for cross-reference:
read-across source
Parameter:
SI
Value:
>= 1.2 - <= 2.5
Test group / Remarks:
all three groups tested at concentration of 0.5, 1 or 2.5%
Interpretation of results:
GHS criteria not met
Conclusions:
The test item produced a stimulation index of < 3 in all groups of Test animals, and is not therefore considered a sensitizer (defined as producing a positive response).
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Skin sensitisation:
in vivo: LLNA, Read across to Sarolaner API, SI < 3, not sensitising


Respiratory sensitisation:
No data available, not minimum required data.


Classification:
Skin: The stimulation indexes were below 3 in all tested concentrations in the murine local lymph node assay (OECD 429). Based on criteria in Table 3.4.2 of Regulation (EC) 1272/2008 and amendments, the substance does not have to be classified as a skin sensitiser.