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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Genetic toxicity in vitro

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (positive)

Genetic toxicity in vivo

Link to relevant study records
Reference
Endpoint:
in vivo mammalian cell study: DNA damage and/or repair
Remarks:
Target chemical
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Key result
Sex:
male
Genotoxicity:
negative
Toxicity:
yes
Remarks:
read-across
Vehicle controls validity:
valid
Remarks:
read-across
Negative controls validity:
valid
Remarks:
read-across
Positive controls validity:
valid
Remarks:
read-across
Additional information on results:
On the basis of the “Read-Across Assesment Framework (RAAF)-consideration on multi-constituent substances and UVCBs” (issued by the ECHA, March 2017) we can say that
the main molecules of the target substance are in the same “pool” like the main molecules of the tested substances.
The functional groups are the same of the compared molecules and the concentration range show quite convincing overlap.

The OECD ToolBox was used to profile this structure and the test structures for structural similarity and organic functional groups to demonstrate similarity. The chemical elements found in the comparator structure (hydrogen, oxygen, carbon and chlorine) are similar in composition and arrangement to those found in the test structure. The molecular weight is also in a similar range to that observed in the test structures.
Conclusions:
The structural similarities between the source and the target substances presented above support the read-across hypothesis. Adequate, reliable and available scientific information indicates that the source and target substances have similar toxicity profiles.

Therefore, based on the considerations above, it can be concluded that the results of the In vivo mutagenicity studies with the source substances is likely to predict the properties of the target substance and are considered as adequate to fulfil the information requirement of Annex VIII.
Executive summary:

Read across results from source substances, that the target substance is considered to be negative for endpoint in vivo mutagenicity.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Justification for classification or non-classification

Based on read-across in vivo studies, it is not classifed as mutagen.