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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Repeated dose toxicity via oral route: Key study: Based on read-across approach from analogue substance P0310, the NOAEL of the substance P-1057 is calculated to be 996 mg/kg bw/day.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
Endpoint:
short-term repeated dose toxicity: oral
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.
Reason / purpose for cross-reference:
read-across source
Principles of method if other than guideline:
Read-across approach from data on an analogue substance.
Key result
Dose descriptor:
NOAEL
Effect level:
996 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: No adverse effects at the highest dose tested.
Remarks on result:
other: Based on a read-across from an analogue substance.
Key result
Critical effects observed:
no
Conclusions:
Based on read-across approach from analogue substance P0310, the NOAEL of the substance P-1057 is calculated to be 996 mg/kg bw/day.
Executive summary:

Based on experimental results obtained in a study according to OECD 407 on analogue substance P0310 where the NOAEL was determined to be 800 mg/kg bw/day, the read-across approach is applied and the NOAEL for the substance P-1057 is determined to be 996 mg/kg bw/day.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
996 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
Read-across from an analogue substance for which a guideline study (Klimish 1) is available.

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Repeated dose toxicity via oral route: Key study: Based on experimental results obtained in a study according to OECD 407 on analogue substance P0310 where the NOAEL was determined to be 800 mg/kg bw/day, the read-across approach is applied and the NOAEL for the substance P-1057 is determined to be 996 mg/kg bw/day.

Justification for classification or non-classification

Based on the available data, the substance is not classified for repeated dose toxicity according to CLP Regulation.