Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Data waiving:
other justification
Justification for data waiving:
other:
Cross-reference
Reason / purpose:
data waiving: supporting information
Reference
Endpoint:
acute toxicity: dermal
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.
Reason / purpose:
read-across source
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 1 782 mg/kg bw
Based on:
other: Read-across from an analogue substance.
Remarks on result:
other: (read-across from an analogue for which LD50 > 2000 mg/kg bw)

The data matrix is included in the reporting format attached.

The results from the read-across approach are expressed (calculated) on the basis of the molecular weight of OS1600 and OS1200 since the basic structures of the target and source substances are the same. No other adaptation is necessary.

Interpretation of results:
other: Not classified according to CLP criteria.
Conclusions:
Based on the read-across approach from the analogue substance OS1200, the LD50 of OS1600 to rats was determined to be greater than 1782 mg/kg bw.
Executive summary:

An acute dermal toxicity study was performed on the analogue substance OS-1200 according to EU Method B.3. Based on these results, the read-across approach was applied and the acute lethal dermal dose of OS1600 to rats was determined to be greater than 1782 mg/kg bw.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion