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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 472-690-5 | CAS number: -
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
The oral LD50 value of the test substance in Wistar rats was established to be within the range of 300-2000 mg/kg bw. According to the OECD 423 test guideline the LD50 cut-off value was considered to be 500 mg/kg bw.
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:
- 3 - 25 October 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001
- Deviations:
- yes
- Remarks:
- Temporary deviations from the maximum level of relative humidity occurred. Laboratory historical data do not indicate an effect of this deviation. The study integrity was thus not adversely affected.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2004
- Deviations:
- yes
- Remarks:
- Temporary deviations from the maximum level of relative humidity occurred. Laboratory historical data do not indicate an effect of this deviation. The study integrity was thus not adversely affected.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl:WI
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8-9 weeks old
- Weight at study initiation: 174 - 229 g
- Fasting period before study: overnight (max. 20 hours)
- Housing: group housing of 3 animals per Macrolon cage containing sterilised sawdust as bedding material and paper as cage-enrichment.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days before start of treatment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.8 - 23 C
- Humidity (%): 41 - 91%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12 - Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Details on oral exposure:
- VEHICLE
- Justification for choice of vehicle: based on trial formulations and on test substance data supplied by the sponsor.
- Specific gravity: 1.036
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw
DOSAGE PREPARATION (if unusual): formulations were prepared within 4 hours prior to dosing. Homogeneity was accomplished to a visually acceptable level. Adjustment was made for specific gravity of the vehicle.
- Doses:
- 2000 mg/kg, 300 mg/kg, 300 mg/kg
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
clinical signs: at periodic intervals on the day of dosing and once daily thereafter until day 15
body weight: days 1 (pre-administration), 8, 15 and at death.
- Necropsy of survivors performed: yes - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 300 - 2 000 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- At 2000 mg/kg, all 3 animals died. In the first 300 mg/kg group, 1 animal died. In the second 300 mg/kg group, no animals died. All decedents were found between days 2 and 3 post-treatment.
- Clinical signs:
- other: At 2000 mg/kg: lethargy, hunched posture, uncoordinated movements, piloerection, ptosis At 300 mg/kg: hunched posture, piloerection The surviving animals had recovered from the clinical signs on days 3 or 6.
- Gross pathology:
- Macroscopic examination of the non-surviving animals treated at 2000 mg/kg revealed abnormalities in the stomach (many crateriform retractions, irregular surface of the fore stomach and glandular mucosa) and in the duodenum and jejunum (irregular surface). Macroscopic examination of three surviving animals treated in the second group at 300 mg/kg revealed abnormalities in the stomach (many crateriform retractions in the fore stomach).
No abnormalities were noted in two surviving animals treated in the first group at 300 mg/kg. Incidental findings in the non-surviving animal treated in the first group at 300 mg/kg included advanced autolyses and missing organs due to cannibalism of the non-surviving animal treated at 300 mg/kg. - Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The oral LD50 value of the test substance in Wistar rats was established to be within the range of 300-2000 mg/kg bw. According to the OECD 423 test guideline the LD50 cut-off value was considered to be 500 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 500 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
The oral LD50 value of the test substance in Wistar rats was established to be within the range of 300-2000 mg/kg bw. According to the OECD 423 test guideline the LD50 cut-off value was considered to be 500 mg/kg bw. Therefore, according to CLP, the substance should be classified as harmful if swallowed (category 4) for acute toxicity by the oral route.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)