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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 406-040-9 | CAS number: 125643-61-0
- 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
The substance caused no mortality in rats upon single oral or dermal exposure to 2000 mg/kg bw (GLP, OECD 401 and 402).
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 June 22, 1989 to July 17, 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to OECD guideline and GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- 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: bred and raisedon the premises of CIBA-GEIGY Ltd (CIBA-GEIGY Ltd, Animal Production, 4332 Stein, Switzerland)
- Age at study initiation: 6-8 weeks
- Weight at study initiation: 177-213 g
- Fasting period before study: over night
- Housing: 5 animals per cage (segregated by sex) in Macrolon cages type 4, with standardized soft wood bedding (Société Parisienne des Sciures, Pantin, France)
- Diet (e.g. ad libitum): Rat chow (NAFAG 890 Tox, NAFAG, Gossau/SG, Switerzland) ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at 5 days before administration
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 55 +/- 10%
- Air changes (per hr): approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12h / 12h - Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80
- Doses:
- 2000 mg/kg bw (application volume was 10 mL/kg bw)
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- Mortality: daily; a.m. and p.m. on working days, a.m. on weekend days.
Signs and symptoms: daily.
Body weight: immediately before administration and on days 7 and 14.
Necropsies: The animals were sacrificed and submitted to a gross necropsy at the end of the observation period. - Statistics:
- From the body weights, the group means and their standard deviations were calculated.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortalities occurred. Common clinical symptoms including piloerection, hunched posture, and dyspnea were seen; the animals recovered within 6 days. Body weight was inconspicuous, Necropsy revealed no abnormalities.
- Mortality:
- None.
- Clinical signs:
- other: Piloerection, hunched posture, and dyspnea were seen (common symptoms in acute tests). The animals recovered within 6 days.
- Gross pathology:
- At necropsy, no deviations from normal morphology were found.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EU 67/548/EEC and EC/1271/2008
- Conclusions:
- Upon an acute oral administration and a 14 day post-treatment observation period, the following LD50 (with 95% confidence limits calculated,
where possible) was determined in rats of both sexes: greater than 2000 mg/kg body weight - Executive summary:
Sprague-Dawley rats of both sexes were treated by single gavage with 2000 mg/kg bw according to the OECD TG 401 (1987); treatment was followed by a 14 day post-treatment observation; at the end of this period the animals were sacrificed for the purpose of necropsy. No mortalities occurred. Common clinical symptoms including piloerection, hunched posture, and dyspnea were seen; the animals recovered within 6 days. Body weight was inconspicuous, Necropsy revealed no abnormalities. The LD50 for both sexes was > 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From June 6, 1989 to August 1, 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to OECD guideline and GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- (1987)
- Deviations:
- no
- 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: bred and raised on the premises (CIBA-GEIGY Ltd, Animal Production, 4332 Stein, Switzerland)
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 215 to 249 g
- Housing: individually housed in Macrolon cages type 3 with standardized soft wood bedding (Société Parisienne des Sciures, Pantin, France)
- Diet: Rat chow (NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland) ad libitum
- Water: water ad libitum
- Acclimation period: at least 5 days before exposure
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/ -2°C
- Humidity (%): 55 +/- 10%
- Air changes (per hr): approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12h / 12h - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Approximately 24 hours before treatment an area on the back of the rat of at least 10% of the body surface was shaved with an electric clipper.
The required amount of the test substance was evenly dispersed on the skin (single application at 2000 mg/kg bw). It was covered with a gauze-lined semiocclusive dressing fastened around the trunk with an adhesive elastic bandage.
After an exposure period of 24 hours the dressing was removed and the skin was cleaned with lukewarm water. Thereafter the skin reaction was appraised repeatedly. - Duration of exposure:
- Single exposure, 24 hours.
- Doses:
- 2000 mg/kg bw.
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- Mortality: daily; a.m. and p.m. on working days, a.m. on weekend days
Signs and symptoms: daily
Body weight: immediately before application and on days 7 and 14
Necropsies: The animals were sacrificed and submitted to a gross necropsy at the end of the observation period. - Statistics:
- From the body weights, the group means and their standard deviations were calculated.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortalities occurred. Common clinical symptoms including piloerection, hunched posture, and dyspnea were seen; the animals recovered within 5 to 7 days. Body weight was inconspicuous, Necropsy revealed no abnormalities
- Mortality:
- None.
- Clinical signs:
- other: Piloerection, abnormal body positions, and dyspnea were seen (common symptoms in acute tests). The animals recovered within 5 to 7 days.
- Gross pathology:
- At autopsy, no deviations from normal morphology were found.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EU 67/548/EEC and EC/1271/2008
- Conclusions:
- Upon an acute dermal administration and a 14 day post-treatment observation period, the following LD50 (with 95% confidence limits calculated, where possible) was determined for both sexes: greater than 2000 mg/kg body weight.
- Executive summary:
Sprague-Dawley rats of both sexes were treated by single dermal application of 2000 mg/kg bw under semiocclusive conditions according to the OECD TG 402 (1987); treatment was followed by a 14 day post-treatment observation; at the end of this period the animals were sacrificed for the purpose of necropsy. No mortalities occurred. Common clinical symptoms including piloerection, hunched posture, and dyspnea were seen; the animals recovered within 5 to 7 days. Body weight was inconspicuous, Necropsy revealed no abnormalities. The LD50 for both sexes was > 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Acute oral toxicity
Acute oral toxicity was tested by gavage application of 2000 mg/kg bw to rats (Ciba-Geigy, 1989). No mortalities occurred. Common clinical symptoms including piloerection, hunched posture, and dyspnea were seen; the animals recovered within 6 days. Body weight was inconspicuous, Necropsy revealed no abnormalities. The study was performed under GLP and according to OECD testing guideline 401.
Acute dermal toxicity
Acute dermal toxicity was tested by semi-occlusive application of 2000 mg/kg bw to rats (Ciba-Geigy, 1989). No mortalities occurred. Common clinical symptoms including piloerection, hunched posture, and dyspnea were seen; the animals recovered within 5 to 7 days. Body weight was inconspicuous, Necropsy revealed no abnormalities. The study was performed under GLP and according to OECD testing guideline 402.
The substance is a viscous, non volalite liquid. Therefore, inhalation testing was not performed.
Justification for selection of acute toxicity – oral endpoint
Study performed according to OECD guideline and GLP
Justification for selection of acute toxicity – dermal endpoint
Study performed according to OECD guideline and GLP
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for acute oral or dermal toxicity under Directive 67/548/EEC.
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for acute oral or dermal toxicity under Regulation (EC) No. 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.
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.