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EC number: 600-734-7 | CAS number: 106276-78-2
- 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
Oral or inhalative administration of the test material / analogue did not cause mortalities, organ changes or clinical signs of toxicity. Therefore, LD50 oral is considered to be greater than 6000 mg/kg bw and LC50 greater than 1000 mg/m3.
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:
- 1977
- 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 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- In an acute oral toxicity study the test substance was administered to Tif: RAIf rats (5/sex/dose) by oral gavage (3170, 4640 and 6000 mg/kg), followed by a 14 day observation period. The test substance was suspended with polyethylene glycol (PEG400). Physical condition and rate of deaths were monitored throughout the whole observation period. At the end of the observation period animals were submitted at random to a necropsy.
- GLP compliance:
- not specified
- Remarks:
- prior to GLP implementation
- 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: raised on the premises
- Weight at study initiation: 160 - 180 g
- Fasting period before study: Animals fasted overnight
- Housing: During the treatment and observation period the animals were housed in groups of 5 in Macrolon cages (type 3)
- Diet: rat food, NAFAG, Gossau SG, ad libitum
- Water: ad libitum
- Acclimation period: a minimum of 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): 55 ± 5
- Photoperiod (hrs dark / hrs light): 10 hours light cycle day - Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 400
- Details on oral exposure:
- DOSAGE PREPARATION:
The test substance was suspended with polyethylene glycol (PEG 400) Before treatment the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer.
Concentration (%) of formulation: 30 % - Doses:
- 3170, 4640 and 6000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Physical condition and rate of deaths were monitored throughout the whole observation period.
- Necropsy of survivors performed: yes - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 6 000 mg/kg bw
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, curved position and ruffled fur. The animals recovered within 8 to 12 days.
- Gross pathology:
- No substance related gross organ changes were seen.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral LD50 in rats of both sexes observed over a period of 14 days is greater than 6000mg/kg. The test material has therefore practically no acute toxicity to the rat by this route of administration.
- Executive summary:
A study similar to OECD Guideline 401 was performed. The acute oral LD50 in rats of both sexes observed over a period of 14 days is greater than 6000mg/kg. The test material has therefore practically no acute toxicity to the rat by this route of administration.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 6 000 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- no data on purity
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- Principles of method if other than guideline:
- K. Sachsse, L. Ullmann, G. Voss and R. Hess: Measurement of inhalation toxicity of aerosols in small laboratory animals. In: Proceedings of the Europ. Soc. for the Study of Drug Toxicity. Vol. XV, pp. 239-251, Zurich, June 1973
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Tif:RAIf (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 185-190 g
- Housing: 9 per cage (Macrolon, Type 4)
- Diet (e.g. ad libitum): NAFAG, Gossau SG, CH; ad lib.
- Water (e.g. ad libitum): unspecified; ad lib.
- Acclimation period: at least 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-1
- Humidity (%): 55+-5
- Photoperiod (hrs dark / hrs light): 10 / 14 - Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Details on inhalation exposure:
- The dust was generated by injecting the test material with the help of a "Grafix Exaktomat Injector" into an air stream which was discharged into the exposure chamber through a nozzle under a pressure of 2 atm. at a rate of 20 L/min. The concentration and the particle size distribution of the dust in the vicinity of the animals were monitored at 1 hour intervals throughout the dust exposure. The concentration was determined gravimetrically by sampling the test atmosphere through a selectron filter of 50 mm diameter and with a pore size of 0.2 µm (Schleicher and Schuell, Feldbach, Switzerland) at an air flow rate of 10 L/min. The size distribution of the dust particles was measured with a Cascade Impactor with selectron filters of 25 mm diameter and with a pore size of 0-2 µm (Schleicher and Schuell) at an air flow rate of 17.5 L/min.
- Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 1.04 +- 0.07 mg/L ( original data: 1041 +- 69 mg/m3)
- No. of animals per sex per dose:
- 9
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation intervals were not reported; weighing was not performed
- Necropsy of survivors performed: yes - Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 1.04 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: No mortality and signs of toxicity observed
- Mortality:
- No mortality observed
- Clinical signs:
- other: No signs of toxicity observed
- Body weight:
- not measured
- Gross pathology:
- No substance related gross organ changes were seen.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LC50 of a 4 hour dust exposure for rats of both sexes is greater than 1000mg/m3 air, when evaluated for a 14 day posttreatment observation period.
- Executive summary:
A study similar to OECD Testguideline 403 was performed. The LC50 of a 4 hour dust exposure for rats of both sexes is greater than 1000mg/m3 air, when evaluated for a 14 day posttreatment observation period.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating conc.
- Value:
- 1 000 mg/m³ air
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In an acute oral toxicity study the test substance was administered to Tif: RAIf rats (5/sex/dose) by oral gavage (3170, 4640 and 6000 mg/kg), followed by a 14 day observation period. The test substance was suspended with polyethylene glycol (PEG 400). Physical condition and rate of deaths were monitored throughout the whole observation period. Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, curved position and ruffled fur. The animals recovered within 8 to 12 days. They were submitted at random to a necropsy at the end of the observation period. No substance related gross organ changes were seen. The acute oral LD50 of the test substance in rats of both sexes observed over a period of 14 days is greater than 6000 mg/kg.
Read across justification
Acute toxicity after inhalation of the test item was not evaluated; reliable, experimental data of an analogue are available. The substances share high similaritiy in structure and have comparable physico-chemical properties. All substances are solids of poor water solubility and insoluble in most of the common organic solvents. The molecular weight of the compounds is higher than 600 g/mol. The molecules includes phthalimid-like structures and bear the potential to release chlorinated phthalimid after enzymatic or bacterial cleavage. Therefore, these analogues substance were choosen to examine acute dermal toxicity and acute inhalation toxicity.
Procedure and observations
Acute inhalation toxicity was examined by a 4h dust exposure (~ 1000 mg/m3) to 9 male and female rats. The exposure was started 15 minutes after onset of the dust production, when the dust had reached an even dispersal throughout the chamber. After a 4 hour inhalation the rats were returned to their cages. Physical condition and incidence of death were monitored throughout an observation period of 14 days. None of the animals died, organ changes or clinical signs of toxicity were not observed.
Results and discussion
Oral or inhalative administration of the test material / analogue did not cause mortalities, organ changes or clinical signs of toxicity. Therefore, LD50 oral is considered to be greater than 6000 mg/kg bw and LC50 greater than 1000 mg/m3.
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 toxicity under Regulation (EC) No. 1272/2008.
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