Registration Dossier
Registration Dossier
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EC number: 219-110-7 | CAS number: 2362-14-3
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
REACH Annex VIII (Section 8.6.1) states that a short-term repeated dose toxicity study (28 days) is required in one species (male and female) utilising the most appropriate route of administration, having regard to the likely route of human exposure. This data requirement has been addressed through provision of a short term repeated dose toxicity test on the substance, which was conducted via the oral route.
In accordance with Column 2 of REACH Annex VIII, the repeated dose toxicity study (required in Section 8.6.1) by the inhalation route does not need to be conducted as exposure of humans via inhalation is extremely unlikely. The substance is not manufactured or imported as such on the EU market, but it is only available as a reacted monomer in an imported polymer with residual levels below 0.1 %; consequently the potential exposure is minimal and it is therefore considered justified to omit repeated dose toxicity testing via the inhalation route.
Data source
Materials and methods
Results and discussion
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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