Registration Dossier
Registration Dossier
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EC number: 926-099-9 | CAS number: -
Additional toxicological data
Administrative data
- Endpoint:
- additional toxicological information
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- High-alumina low-silica HT stone wool fibers: A chemical compositional range with high biosolubility
- Author:
- Guldberg M, Jensen SL, Knudsen T, Steenberg T, Kamstrup O
- Year:
- 2 002
- Bibliographic source:
- Regulatory Toxicology and Pharmacology 35:217-226
Materials and methods
- Type of study / information:
- Experimental data
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: European Commission guidelines for biopersistence studies
- GLP compliance:
- not specified
Test material
- Reference substance name:
- MMVF note Q fibres
- IUPAC Name:
- MMVF note Q fibres
- Details on test material:
- - Name of test material (as cited in study report): RIF4205, RIF43001-1, RIF43005, RIF44001, RIF41001, RIF42007-2, RIF42020-2, RIF42015-2, RIF42026, MMVF34, RIF42020-2, RIF42015-2
- Substance type: Fibre
- Physical state: Solid
- Analytical purity: Appr. 99.9%
Constituent 1
Results and discussion
Any other information on results incl. tables
Half times (T1/2) of MMVF note Q fibres (length > 20 μm) was in the range 5-9 days days in short-term biopersistence studies and 15-37 days in intratracheal biopersistence studies, depending on the specific fibre.
Applicant's summary and conclusion
- Conclusions:
- MMVF note Q fibres, longer than 20 μm, were tested in intratracheal biopersistence studies. The results showed that T1/2 was shorter than 40 days. Thus, MMVF note Q fibres comply with the criteria in Regulation (EC) 1272/2008 for exoneration (exemption) from classification as a carcinogen. Consequently, MMVF note Q fibres shall not be classified as carcinogenic according to the criteria in Council Directive 67/548/EEC and Regulation (EC) 1272/2008.
- Executive summary:
The short-term biopersistence test by inhalation showed that MMVF note Q fibres longer than 20 μm have a weighted half-life less than 10 days, and the short-term biopersistence test by intratracheal instillation has shown that MMVF note Q fibres longer than 20 μm have a weighted half-life less than 40 days. Thus, MMVF note Q fibres fulfil the criteria for exemption from classification as carcinogenic according to the Regulation (EC) 1272/2008 (the CLP Regulation). MMVF note Q fibres shall not be classified as carcinogenic according to the criteria in Council Directive 67/548/EEC and Regulation (EC) 1272/2008.
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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