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EC number: 245-442-7 | CAS number: 23128-74-7
- 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
rat oral: LD50 > 7750 mg/kg bw
rat, inhalation: no data available
rabbit, dermal: LD50 > 2000 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- no details on test substance, limited documentation
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Tif: RAIf (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: own breeding facility
- Weight at study initiation: 160 to 180 grams
- Fasting period before study: overnight
- Housing: groups of 5 in Macrolon cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1
- Humidity (%): 55 +/- 5
- Photoperiod (hrs dark / hrs light): 14/10 - Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- DOSAGE PREPARATION (if unusual):
Test substance was suspended with polyethylene glycol (PEG 400). Before treatment the suspension was homogenously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer.
VEHICLE
- Concentration in vehicle: 30 % - Doses:
- 4640, 6000, 7750 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
- Necropsy of survivors performed: yes - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 7 750 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no deaths
- Clinical signs:
- other: Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmos, curved position and ruffled fur. The animals recovered within 8 to 13 days.
- Gross pathology:
- No substance related gross organ changes were seen.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral LD50 of the test article in rats of both sexes observed over a period of 14 days is greater than 7750 mg/kg.
- Executive summary:
The test substance was tested for acute toxicity in male and female rats in a study comparable to OECD 401 with restrictions (limited details, no body weight monitoring, no details on test substance). The test substance was dissolved in polyethylene glycol and administered by gavage to 5 rats per sex per dose (fasted overnight) in the following concentrations: 4640, 6000, 7750 mg/kg bw. No deaths occured and the LD50 was defined as greater than 7750 mg/kg bw. Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmos, curved position and ruffled fur. The animals recovered within 8 to 13 days. They were submitted at random to a necropsy at the endof the observation period. No substance related gross organ changes were reported.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 7 750 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- author unknown, very brief, limited details, no necropsy
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2933 g (mean weight)
- Housing: 1 animal/cage
- Diet: Nafag Würfel Nr. 84
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +/-2
- Humidity (%): 55 +/-5
- Photoperiod (hrs dark / hrs light): 10/14 - Type of coverage:
- occlusive
- Vehicle:
- other: Gum arabic 1% in aquous solution (tap water)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 200-300 cm²
- Clipping of the fur
REMOVAL OF TEST SUBSTANCE
- Washing: yes, with hand warm water and sponge
- Time after start of exposure: 24h - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 8 days
- Frequency of observations and weighing: unknown
- Necropsy of survivors performed: no
- Other examinations performed: body weight - Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no deaths
- Clinical signs:
- other: no data
- Gross pathology:
- no findings
- Other findings:
- no findings for skin
- Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Acute oral toxicity:
In the key study, groups of five fasted Tif: RAIf (SPF) rats per sex were given a single oral dose of the test substance (30%) in polyethylene glycol at doses of 4640, 6000, 7750 mg/kg bw and observed for 14 days. No mortalities occurred. Clinical signs were recorded for rats in all dosage groups 2 hours after substance administration like sedation, dyspnea, exophthalmos, curved position and ruffled fur. The animals recovered within 8 to 13 days. Necropsy performed with animals selected randomly did not show any gross organ changes. Based on the results of this study an oral LD50 (rat) greater than 7750 mg/kg bw was derived, the test substance is practically non-toxic in males and females.
This low oral toxicity potential was confirmed by three supporting studies. In the first supporting study, groups of fasted, Chinese hamsters (5/sex) were given a single oral dose of test substance in polyethylene glycol at a dose level of 3000 mg/kg bw and observed for 14 days. No mortalities occurred. Clinical symptoms like ruffled fur, dyspnea and curved body position were seen after 1 hour (fully reversible within 5 days). A decrease in body weight was reported after 7 days (non-reversible within 14 days). There were no treatment related necropsy findings. In two further acute toxicity studies single groups of CFE (SPF) rats (5/sex) and Swiss mice (5/sex) were given a single dose of test substance (25%) in gum arabic (1%) at a dose of 5000 mg/kg bw followed by an observation period of 8 days. No mortality occurred. Clinical signs like ruffled fur, ataxia, dyspnea and somnolence were detected.
Acute dermal toxicity:
In an acute dermal toxicity study one group of New Zealand white rabbits (3 males) were dermally exposed to the test substance (80%) in gum arabicum (1%)/water for 24 hours at a dose level of 2000 mg/kg bw followed by an observation period of 8 days. Besides reduction of body, weight no treatment-related effects (like clinical signs, necropsy findings) were seen. No mortalities occurred. Based on these results, a dermal LD50 (rabbit) > 2000 mg/kg bw was derived. The test substance is practically non-toxic based on the LD50 in males and females.
Acute inhalative toxicity:
One acute inhalation study conducted by IBT is available. In this study, five Sprague-Dawley rats per sex were exposed to an atmosphere containing the test article for 4 hours followed by a 14 day observation period. No mortalities occurred; The reported maximum concentrations of test material was 3.9 mg/m³. Considering the history of IBT (reporting of fake data), the reliability of these studies is questionable and an accurate Klimisch rating is impossible. Consequently, the study is rated with Klimisch 4. Based on the history of IBT, these studies can only be rated with Klimisch 4 (see above). However, since no further testing is necessary according to Annex VIII (8.5) of Regulation (EC) No 1907/2006 (reliable data on two other routes are provided) this inhalation study is disregarded.
Justification for classification or non-classification
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, dermal or inhalatory 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.
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