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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: Key study: Based on read-across approach from analogue substance P0310, the substance P-1057 is considered as not irritating to the skin.

Eye irritation: Key study: Based on read-across approach from analogue substance P0310, the substance P-1057 is considered as not irritating to the eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in 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 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.
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: Based on a read-across from an analogue subtance.
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: Based on a read-across from an analogue substance
Interpretation of results:
GHS criteria not met
Conclusions:
Based on read-across approach from analogue substance P0310, the substance P-1057 is considered as not irritating to the skin.
Executive summary:

Based on experimental results obtained in a study according to OECD 404 on analogue substance P0310 where the test item did not elicit any skin reactions at the application site of any animal at any of the observation times, the read-across approach is applied and the substance P-1057 is considered as not irritating to the skin.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in 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 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.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: Based on a read-across from an analogue susbtance.
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: Based on a read-across from an analogue substance.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: Based on a read-across from an analogue substance.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: Based on a read-across from an analogue substance.
Interpretation of results:
GHS criteria not met
Conclusions:
Based on read-across approach from analogue substance P0310, the substance P-1057 is considered as not irritating to the eyes.
Executive summary:

Based on experimental results obtained in a study according to OECD 405 on analogue substance P0310 where the instillation of the test item into the eye resulted in mild, early-onset and transient ocular changes, no longer evident 48 hours after treatment, the read-across approach is applied and the substance P-1057 is considered as not irritating to the eyes.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation: Key study: Based on experimental results obtained in a study according to OECD 404 on analogue substance P0310 where the test item did not elicit any skin reactions at the application site of any animal at any of the observation times, the read-across approach is applied and the substance P-1057 is considered as not irritating to the skin.

Eye irritation: Key study: Based on experimental results obtained in a study according to OECD 405 on analogue substance P0310 where the instillation of the test item into the eye resulted in mild, early-onset and transient ocular changes, no longer evident 48 hours after treatment, the read-across approach is applied and the substance P-1057 is considered as not irritating to the eyes.

Justification for classification or non-classification

Based on the available information, the substance is not classified for irritation according to CLP Regulation.