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Diss Factsheets
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EC number: 289-068-2 | CAS number: 85959-73-5
- 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
In the acute oral toxicity study, the LD50
was determined to be 1666 mg/kg bw for male/female.
Based on the criteria in the Regulation CE n.1272/2008, the tested
substance needs to be classified as Acute Tox. Cat. 4.
No study available for dermal and inhalation toxicity.
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH
- Age at study initiation: 9-12 weeks
- Weight at study initiation: males: 195-265 g; females: 173-218 g
- Housing: 5 animals per Makrolon cage type III
- Diet (e.g. ad libitum): pellets of Kliba 343 ad libitum
- Water (e.g. ad libitum): tap water from Itingen, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 40 -70
- Air changes (per hr): 10/15
- Photoperiod (hrs dark / hrs light): 12 / 12 - Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- MAXIMUM DOSE: 20 ml at 5000 mg/kg bw (group 5)
RATIONALE FOR SELECTION OF DOSES:Oral administration has been proven to be an efficacious method to assess the test article absorption. - Doses:
- Group 1: 10 ml at 750 mg/kg bw
Group 2: 10 ml at 1000 mg/kg bw
Group 3: 10 ml at 2000 mg/kg bw
Group 4: 20 ml at 3000 mg/kg bw
Group 5: 20 ml at 5000 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 clinical observations: 4 times in day 1; daily during days 2-15
- Frequency of weighing: before application, after 8 days and after 15 days.
- Necropsy of survivors performed: yes, all animals - Statistics:
- The LOGIT-Model (COX, Analysis of Binary Data, London 1977) was applied to estimate the toxicity value. Additionally, the 90, 95 and 99% confidence intervals for the toxicity for each sex the slope of the concentration response line were estimated.
- Preliminary study:
- N.A.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 2 053 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 1 439 - < 4 878
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 336 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 934 - < 1 859
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 666 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 1 344 - < 2 147
- Mortality:
- Based on the values indicated in Appendix A1:
No mortality at 750 and 1000 mg/kg bw.
1 animal died at day 2 for 2000 mg/kg bw
5 animals died at day 2 for 3000 mg/kg bw
5 animals died at day 2 for 5000 mg/kg bw - Clinical signs:
- The following symptoms were observed:
750 mg/kg bw: dyspnea
1000 mg/kg bw: sedation, dyspnea, curved body position, ruffled fur
2000 mg/kg bw: sedation, dyspnea, curved body position, ruffled fur, ataxis (females)
3000 mg/kg bw: sedation, dyspnea, curved body position, ruffled fur, ataxis
5000 mg/kg bw: sedation, dyspnea, curved body position, latero-abdominal position, ventral body position, ruffled fur, ataxis - Body weight:
- No effects on the body weight were noted.
- Gross pathology:
- In killed rats, no pathologic changed were observed.
In dead animals some changes were observed (stomach and intestine descoloration, mottled lungs and discoloration, spleen and kidney discoloration. - Other findings:
- N.A.
- Interpretation of results:
- other: Acute Toxicity Category 4
- Conclusions:
- In this acute oral toxicity study, the LD50 was determined to be 1666 mg/kg bw for male/female.
- Executive summary:
In this acute oral toxicity study, the LD50 was determined to be 1666 mg/kg bw for male/female.
Based on the criteria in the Regulation CE n.1272/2008, the tested substance needs to be classified as Acute Tox. Cat. 4.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 666 mg/kg bw
- Quality of whole database:
- Good report
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
In the acute oral toxicity study, the LD50
was determined to be 1666 mg/kg bw for male/female.
Based on the criteria in the Regulation CE n.1272/2008, the tested
substance needs to be classified as Acute Tox. Cat. 4, H302.
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.
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