Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 285-561-1 | CAS number: 85117-09-5 Mixtures of chemical substances produced by burning (below 1200°C) natural variants of limestone or chalk containing from 10 to 20%, or more, of clayey or siliceous materials which are predominantly SiO2, Al2O3 and iron oxide. Consist primarily of 2CaOsb.2, Ca(OH)2, CaO and 2CaOsb.2O3. 3CaO.2SiO2, 4CaOsb.2O3. Fe2O3, 2CaOsb.2O3sb.2, CaCO3 and SiO2 may also be included.
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
According to Annex VIII, point 8.6.1, column 2 of Regulation No 1907/2006, information on short-term toxicity (28-day study) by the dermal route shall be provided if (1) inhalation of the substance is unlikely; and (2) skin contact in production and/or use is likely; and (3) the physicochemical and toxicological properties suggest potential for a significant rate of absorption through the skin. For hydraulic lime, inhalation can be anticipated. Therefore, provision (1) of Annex VIII, point 8.6.1 is not fulfilled. Testing of short-term toxicity (28 days) via the dermal route is therefore not required. Furthermore, following the HERAG guidance for metals and metal salts (see section 7.1.2 of the technical dossier), a dermal absorption rate in the range of maximally 0.1-1.0 % can be anticipated. Dermal absorption in this order of magnitude is not considered to be “significant”. Therefore, also provision (3) of Annex VIII, point 8.6.1 is not fulfilled. In conclusion, testing for short-term toxicity of hydraulic lime via the dermal route is not required according the criteria laid down in Annex VIII , point 8.6.1. It can safely be anticipated that there will be no systemic risk in case of dermal short-term exposure to hydraulic lime. Additional toxicity studies are not expected to provide further information, thus there is no need for any further repeated dose testing.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
