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Administrative data

Description of key information

Based on the read-across approach from the analogue substance MPKO, OS1600 was determined to be non-sensitizer to the skin in both guinea pig (Buehler) and LLNA studies.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-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 from an analogue substance for which a guideline study (Klimish =1) is available.
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
See attached reporting format and read-across rationale.
Reason / purpose:
read-across source
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
Induction 100 %, challenge 25 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Results with the analogue subtance.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
Induction 100%, challenge 25 %
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
other: Results with the analogue substance.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
Induction 0 %, challenge 25 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Negative control of the study with the analogue subtance.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
Induction 0 %. challenge 25 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Negative control of the study with the analogue subtance.

The data matrix is included in the reporting format attached.

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the read-across approach from MPKO, OS1600 was determined to be non-sensitizer to the skin.
Executive summary:

A skin sensitization study was performed with the analogue substance MPKO according to OECD Guideline 406. MPKO was determined to be non-sensitizer to the skin. Based on these results, the read-across approach was applied and OS1600 was determined to be non-sensitizer to the skin.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Key study: Read-across approach from experimental data on the analogue substance MPKO: A skin sensitization study was performed using the method of Ritz & Buehler and according with OECD Guideline 406 (GLP study). Based on the experimental data on the analogue substance MPKO, the hydrolysis product of OS1600 (non-sensitizer since after the challenge, erythema was absent to faint in the induced group and absent in the naive control group), the substance OS1600 was also determined to be non-sensitizer.

Supporting study: Read-across approach from experimental data on the analogue substance MPKO: A Local Lymph Node Assay was performed with MPKO in accordance with OECD Guideline 429 (GLP study). Based on the experimental data on the analogue substance MPKO, hydrolysis product of OS1600 (non-sensitizer since the SI values calculated for concentrations 25, 50 and 100% were 1.5, 1.1 and 1.3 respectively (SI < 3)), the substance OS1600 was also considered to be non-sensitising to the skin.

Justification for selection of skin sensitisation endpoint:

Based on the results with analogues, the Buehler test (key study) may be more appropriate to assess the skin sensitization of oximes than the LLNA. Nevertheless, both studies were negative.

Justification for classification or non-classification

Based on the available experimental results, the substance OS1600 is not classified for skin sensitization in accordance with CLP Regulation (EC) no. 1272/2008.