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EC number: 252-525-1 | CAS number: 35355-77-2 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 15880:2.
- 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
- Acute oral toxicity: In a study (1973) similar to OECD TG 401, non-GLP, the LD50 was determined to be greater than 6000 mg/kg bw in rats. Responses to the administered test substance were negligible. No death occured at any dosage levels used.
- Acute inhalative toxicity: No study was performed with the test item. Reliable experimental data from an analogue substances are available. Based on the absence of mortality in a study (2018) according to OECD TG 403 and GLP, the LC50 was determined to be greater than 5 mg/L in male and female rats.
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:
- 1973
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Tif:RAI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 6 and 7 weeks old
- Weight at study initiation: 160 to 180 g
- Fasting period before study: one night before starting the treatment
- Housing: the animals were segregated and housed in Macrolon cages in groups of 5.
- Diet: The animals received water and food ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1 °C
- Humidity: 50 % - Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- - Concentration used: 30% (w/v)
- Doses:
- 4640, 6000 mg/kg bw (no higher doses were possible)
- No. of animals per sex per dose:
- 5 animals per sex per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 6 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occured
- Clinical signs:
- Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased. The animals had recovered wihtin 5 days.
- Body weight:
- no data
- 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 substance in rats of both sexes observed over a period of 7 days is greater than 6000 mg/kg.
- Executive summary:
Groups of twenty, 6 to 7 weeks old Tif. RAI rats (10/sex) were given a single oral dose of the test substance in carboxymethyl cellulose (CMR) at doses of 4640 and 6000 mg/kg bw (no higher doses were possible) and observed for 7 days. Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased. The animals had recovered within 5 days and no death occured at any dosage levels used. The acute oral LD50 of the test substance after a single oral administration to rats is greater than 6000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 6 000 mg/kg bw
- Quality of whole database:
- Study was conducted similar to OECD TG 401, non-GLP, Klimisch 2.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Please, see the attached justification.
- Reason / purpose for cross-reference:
- read-across source
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: CAS 6417-83-0
- Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating conc.
- Value:
- 5 mg/L
- Physical form:
- inhalation: aerosol
- Quality of whole database:
- Study was conducted according to OECD TG 403, GLP, Klimisch 1.
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute oral toxicity
In an acute oral toxicity study (BASF, 1973), groups of twenty 6 to 7 weeks old Tif. RAI rats (10/sex) were given a single oral dose of the test substance in carboxymethyl cellulose (CMR) at doses of 4640 and 6000 mg/kg bw (no higher doses were possible) and observed for 7 days. Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased. The animals had recovered within 5 days and no death occured at any dosage levels used. The acute oral LD50 of the test substance after a single oral administration to rats is greater than 6000 mg/kg bw.
Acute inhalative toxicity
A study on acute toxicity via inhalation was not performed for the test item. Reliable experimental data for an analogue approach are available. Please, see the attached read-across justification in section 7.2.2 or 13.
CAS 6417-83-0:
An acute inhalation toxicity study was performed according OECD TG 403 and GLP principles with male and female rats. The test concentration was analyzed to be approximately 5 mg/L. During exposure, slow breathing and/or laboured breathing was seen for all animals. Lethargy, hunched posture, laboured respiration were observed in all animals. Animals recovered from the clinical signs at day 4 and 5. No mortality was seen during exposure or during the 14 day observation period. Red staining of the animals was noted throughout the observation period and was considered to be due to the staining properties of the test item and therefore not toxicologically relevant. Overall body weight gain in males and females was within the range expected for rats of this strain and age used in this type of study. No abnormalities were found at macroscopic post mortem examination of the animals.
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. No mortality occurred in both tests. As a result, the substance is not considered to be classified for acute oral or inhalative toxicity under Regulation (EC) No. 1272/2008, as amended for the fourteenth time in Regulation (EC) No. 2020/217.
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