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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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EC number: - | CAS number: -
Acute Toxicity: oral
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- calculation (if not (Q)SAR)
- Adequacy of study:
- key study
- Study period:
- 2018
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- accepted calculation method
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
- Principles of method if other than guideline:
- Accepted calculation method. Annex 1 of the EU Regulation (EC) No 1272/2008 on the classification, labelling and packaging of substances and mixtures (CLP Regulation) contains detailed methods for calculation of data of mixtures. In general, the toxicities of the components are added up to calculate the toxicity of a mixture. The concentrations of the components are taken into account and their toxicities. For calculation purpose, the substance is regarded as a mixture of several components.
- GLP compliance:
- no
- Remarks:
- in silico study
- Test type:
- other: calculation
- Limit test:
- no
Test material
- Test material form:
- liquid: viscous
- Details on test material:
- - State of aggregation: contains polymer which is not soluble after dessication
- Particle size distribution: not appropriate (liquid)
- Mass median aerodynamic diameter (MMAD): not appropriate
- Geometric standard deviation (GSD): not appropriate
- Shape of particles: not appropriate
- Surface area of particles: not appropriate
- Crystal structure: not appropriate
- Coating: not appropriate
- Surface properties: surface tension see appropriate section of IUCLID
- Density: see appropriate section of IUCLID
- Moisture content: see above
- Residual solvent: see above
- Activation: not appropriate
- Stabilisation: not required as long as treated properly and instructions of manufacturer are followed
Constituent 1
- Specific details on test material used for the study:
- major constituents of the substance were tested in several published studies
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- Data calculated on basis of rat and mouse tests
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Control animals:
- yes
- Details on study design:
- Calculation
Results and discussion
Effect levels
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 250 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: calculation
- Other findings:
- The LD50 rat, acute toxicity, oral, for the substance is calculated to be > 250 mg/kg bw
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- The calculated LD50 rat, acute toxicity, oral, for the substance is > 250 mg/kg bw
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.
