Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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: 946-006-5 | CAS number: 1175539-64-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Acute toxicity: oral: LD50 > 2000 mg/kg bw (OECD 401 in rats; OECD 401, K, rel.1);
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From May 2 to 17, 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study conducted in compliance with OECD Guideline No. 401 without any deviation.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 24 February 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- 31 July 1992
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage IFFRA CREDO (69210 L'Arbresle, France)
- Age at study initiation: 5-7 weeks
- Weight at study initiation: M: 190.5-209.4 g / F: 175.8-198.4 g
- Fasting period before study: Animals were fasted before dosing and then for 3-4 h after dosing.
- Housing: Animals were housed in groups of 5 in polypropylene cages.
- Diet: Pelleted diet, ad libitum.
- Water: tap water, ad libitum.
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 2 °C
- Humidity: 30-70 %
- Air changes: 10 changes/h
- Photoperiod: 12 h dark / 12 h light
IN-LIFE DATES: From: May 02, 2001 To: May 17, 2001 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- PEG 300
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 2.37 ml/kg bw
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of weighting: On test days -1, 1 (prior to administration), 4, 8 and 15
- Frequency of observations:
Mortality / viability/ clinical observations: during the first 30 minutes and at approximately 1, 2, 3,4, 5 and 6 hours after administration on test day 1 (with the clinical signs) and at least only daily thereafter.
- Necropsy of survivors performed: Yes; All animals were killed at the end of the observation period by intraperitoneal injection of Pentaboarbital sodique - Statistics:
- None
- Preliminary study:
- See below
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- other: None
- Gross pathology:
- No macroscopic findings were recorded at necropsy
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD50 (combined) > 2000 mg/kg bw. Under the test conditions, the substance is not classified according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
- Executive summary:
In an acute oral toxicity study (limit test) performed according to OECD Guideline No. 401 and in compliance with GLP, male and female Sprague-Dawley rats were administered a single oral dose of 2000 mg test material/kg bw by gavage. Animals were observed for mortality, clinical signs and bodyweights for 14 days and at the end of the study the surviving animals were sacrificed for macroscopic examination.
All animals survived until the end of the study period. No clinical signs nor effects on body weight were reported during the course of this study. No macroscopic findings were recorded at necropsy.
LD50 (combined) > 2000 mg/kg bw
Under the test conditions, the substance is not classified according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The key study is GLP-compliant and of high quality
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- Not required for an Annex VII dossier
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- Not required for an Annex VII dossier
Additional information
Acute toxicity: oral
A key study was identified (Evik, 2001, Rel.1). In this acute oral toxicity study (limit test) performed according to OECD Guideline No. 401 and in compliance with GLP, male and female Sprague-Dawley rats were administered a single oral dose of 2000 mg test material/kg bw by gavage. Animals were observed for mortality, clinical signs and bodyweights for 14 days and at the end of the study the surviving animals were sacrificed for macroscopic examination.
All animals survived until the end of the study period. No clinical signs nor effects on body weight were reported during the course of this study. No macroscopic findings were recorded at necropsy.
LD50 (combined) > 2000 mg/kg bw
Justification for classification or non-classification
Harmonized classification:
The substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.
Self classification:
Acute toxicity via Oral route:
Based on the available data the substance is not classified according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS as the oral LD50 is higher than 2000 mg/kg bw and no effects were observed at this dose level.
Acute toxicity via Dermal route:
No data was available.
Acute toxicity (Inhalation):
No data was available.
Specific target organ toxicity: single exposure (Oral):
Based on the available data, the classification criteria according to the Annex VI of the Regulation (EC) No. 1272/2008 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 Annex VI of the Regulation (EC) No. 1272/2008 are not met since narcotic effects were not observed in the acute oral toxicity study.
Specific target organ toxicity: single exposure (Dermal):
No data was available
Specific target organ toxicity: single exposure (Inhalation):
No data was available.
Based on its composition (> 10% of aspiration toxicants), and description as mobile (see IU section 4.1 -4.2) the substance is classified for aspiration hazard category 1, H304 according to CLP Regulation and GHS.
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.