Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

- Acute toxicity: via Inhalation route: Waiver. The substance is a monomer, imported in EU as polymers only, therefore exposure of humans via inhalation is not likely.


- Acute toxicity: via Dermal route: Waiver. The substance is a monomer, imported in EU as polymers only, therefore skin contact in production and/or use is not likely.

Key value for chemical safety assessment

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
exposure considerations
Justification for data waiving:
the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Data waiving:
exposure considerations
Justification for data waiving:
the study does not need to be conducted because skin contact in production and/or use is not likely

Additional information

This dossier is an opt-out dossier including only endpoints of Annex VIII (Acute Inhalation toxicity and Acuter Dermal toxicity).


Annex VII endpoint (Acute Oral toxicity) is available in the dossier of the lead registrant. 

Justification for classification or non-classification

Harmonised classification:


The substance has no harmonised classification according to the Regulation (EC) No. 1272/2008 (CLP). 


 


Self classification:


Acute toxicity via Oral route:


Based on the available information, the substance is classified under Category 4 according to the CLP and the GHS as the LD50 Cut off is 300 mg/kg bw.


Acute toxicity via Dermal route: 


No study is available.


Acute toxicity via Inhalation:


No study is available. 


Specific target organ toxicity: single exposure (Oral):


The classification criteria according to the CLP and to the GHS as specific target organ toxicant (STOT) – single exposure, oral are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value (oral) for a Category 1 classification (C≤ 300 mg/kg bw) and at the guidance value (oral) for a Category 2 classification (2000 mg/kg bw≥C > 300 mg/kg bw). No classification is required. 


The criteria for Transient Organ effects (STOT-SE Category 3) according to the CLP and to the GHS are not met since narcotic effects were not observed in the acute oral toxicity study. 


Specific target organ toxicity: single exposure (Dermal):


No study is available.


Specific target organ toxicity: single exposure (Inhalation):


No study is available. 


Aspiration hazard:


The substance is not a hydrocarbon and no effects were observed on lungs in oral studies, therefore the criteria for aspiration toxicity according to the CLP and to the GHS are not met.