Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available

Effects on developmental toxicity

Description of key information
The substance was predicted to be "toxicant" by the developmental toxicity model (CAESAR).
Link to relevant study records
Reference
Endpoint:
developmental toxicity
Type of information:
(Q)SAR
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The prediction was performed by a valid QSAR model and appears to be reliable as the substance is included in the applicability domain of the model.
Justification for type of information:
QSAR prediction: migrated from IUCLID 5.6
Guideline:
other: REACH guidance on QSARs R6, May 2008
Principles of method if other than guideline:
General model for estimating the developmental toxicity.
Abnormalities:
not specified
Developmental effects observed:
not specified

Model assessment

the prediction is considered as reliable considering the following issues:

- quite similar compounds with known experimental value in the training set have been found;

- the similar molecules found in the training set have experimental values that agree with the predicted value;

- the accuracy of prediction for similar molecules found in the training set is good;

- all atom centered fragment of the compound have been found in the compounds of the training set;

-descriptors for this compound have values inside the descriptor range of the compounds of the training set.

Details are provided in attachment on the section: "attached full study report".

Conclusions:
Prediction is Toxicant, the result appears reliable.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available (further information necessary)
Quality of whole database:
The quality of the database is not good since no experimental data are available.
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

The substance was predicted to be "toxicant" by the developmental toxicity model (CAESAR). Moreover, the substance is classified as Repr. 2; H361d (Repr3; R63) by Danish ministry of the environment (Envirnonment Protection Agency) even if there are not literature data to support this classification.

Overall, no experimenental data are available for a comprehensive assessment.


Justification for selection of Effect on developmental toxicity: via oral route:
Only data by QSAR model are available.

Justification for classification or non-classification

According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the substance is not classified for toxicity to reproduction because of inconclusive data.

Additional information