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EC number: 250-063-5 | CAS number: 30125-47-4
- 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
Suitable acute toxicity studies were only available for oral and dermal adminisration of the test substance. As the study regarding acute inhalation toxicity obtained methodological deficincies, read across on reliable data from an analogue substance was performed.
- Oral: similar to OECD guideline 401, prior GLP, LD50 (rat) >10000 mg/kg bw (no mortality or signs of toxicity)
- Inhalation: read across to CAS 106276-80-6, similar to OECD guideline 403, prior GLP, LC50 (rat) >1.04 mg/L (no mortality or signs of toxicity)
- Dermal: similar to OECD guideline 402, prior GLP, LD50 (rat) >2500 mg/kg bw (no mortality or signs of 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
- Study period:
- 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- very brief documentation
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- application volume exceeds 20 mL/kg bw; 7 days observation period
- GLP compliance:
- no
- Remarks:
- performed prior to the implementation of GLP
- 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: Gassner
- Mean weight at study initiation: males: 229 g (208-246 g); females: 170 g (165-171 g)
ENVIRONMENTAL CONDITIONS: Not reported - Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 0.5% aqueous solution
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 35 % suspension in 0.5 % aqueous CMC solution - Doses:
- 10000 mg/kg bw (28.5 mL/kg bw)
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 7 days
- Frequency of weighing: day 1, 5 and 8
- Observation of clinical signs: on the day of administration and once daily afterwards (on working days)
- Necropsy of survivors performed: yes - Statistics:
- not performed
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality occurred.
- Mortality:
- No mortality was observed
- Clinical signs:
- other: Yellow faeces
- Gross pathology:
- No abnormalities were observed
- Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 10 000 mg/kg bw
- Quality of whole database:
- Similar to OECD TG 401, pre-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
- Reason / purpose for cross-reference:
- read-across: supporting information
- Reason / purpose for cross-reference:
- read-across: supporting information
- 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 no clinical signs were observed aup to and including the highest technically attainable concentration.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating conc.
- Value:
- 1 041 mg/m³ air
- Physical form:
- inhalation: dust / mist
- Quality of whole database:
- Read across to CAS 106276-80-6: similiar to OECD TG 403, pre-GLP, Klimisch 2
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:
- comparable to guideline study with acceptable restrictions
- Remarks:
- incomplete documentation; occlusive treatment; 24 h exposure
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- occlusive treatment; 24 h exposure
- GLP compliance:
- no
- Remarks:
- performed prior to the implementation of GLP
- 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: Wiga, Ottobrunn, Germany
- Mean weight at study initiation: males 136 g, females 119 g
ENVIRONMENTAL CONDITIONS: Not reported - Type of coverage:
- occlusive
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 0.5% solution in water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal, p.c., 50 cm²
- % coverage: considered to be > 10 % (mean bw of 136 g, calculated with the formula " surface area = 9.1 x bw (exp) 0.67"
- Type of wrap if used: no data
- Site of exposure: dorsal
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water containing mild detergent
- Time after start of exposure: no data
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.5 g/kg bw (5mL/kg bw)
- Concentration (if solution): 50 % suspension solution (in water 0.5% CMC)
- For solids, paste formed: yes - Duration of exposure:
- 24 h
- Doses:
- 2500 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 weighing: before application
- Frequency of observations: daily (on working days: day 1, 2, 5, 6, 7, 8, 9, 12, 13 and 14)
- Necropsy of survivors performed: yes - Statistics:
- not performed
- Preliminary study:
- no data
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 500 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality and no clinical signs were observed.
- Mortality:
- No mortality ocurred.
- Clinical signs:
- other: No clinical signs were observed.
- Gross pathology:
- No abnormalities were observed.
- Other findings:
- After 24 h and 8 days: local yellow substance residues
- Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 500 mg/kg bw
- Quality of whole database:
- similiar to OECD TG 402, pre-GLP, Klimisch 2
Additional information
Oral:
Acute oral toxicity of the test item (purity 100%), dissolved in an aqueous solution 0.5% CMC, was determined by single oral (gavage) administration to male and female rats at a concentration of 10000 mg/kg bw. The animals were observed for 7 days and checked for mortality, body weight change and clinical signs of toxicity. All animals survived until scheduled day of necropsy which did not reveal any findings. Excretion of yellowish feces was reported. The LD50 after oral application is therefore considered to be higher than 10000 mg/kg bw.
Inhalation:
Acute inhalation toxicity was examined for the test substance itself. Exposure of 12 rats for 8h to an atmosphere enriched with the test material did not cause mortality or findings in necropsy. However, due to an unsuitable test method for non-volatile or non-dusty solids, the study is regarded as invalid and read across to CAS 106276-80-6 was performed.
Acute inhalation toxicity of the analogue substance was examined after 4h dust exposure of 1000 mg/m³ (highest technically attainable conc., nose only) to 9 male and female Tif: RAif 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 conditions 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. Therefore, the LC50 is considered to be greater than 1.04 mg/L air.
In an inhalation hazard test with the thermal decomposition products of the analogue substance, nine male and nine female rats of the Tif: RAIf (SPF) strain were exposed for 30 minutes (snouts and nostrils only) to the fumes produced upon thermal decomposition of the test material at a temperature of 300° C. Exposure to the fumes was tolerated by all animals. No mortality and signs of toxicity were observed after 30 min exposure to the vapour/ fume of the thermal decomposition products of the test substance at 300°C.
Based on the physico-chemical, structural as well as toxicoligical similarities, the same outcome is assumed for the actual substance.
Dermal:
To determine acute dermal toxicity of the test substance, 2500 mg/kg bw of the material (purity 100%) was applied onto dorsal skin of male and female rats for 24h under occlusive conditions. The animals were observed for 14 days and checked daily for mortality and clinical signs of toxicity. None of the rats died; yellowish staining of the treatment site was observed. The LD50 after dermal application is therefore considered to be higher than 2500 mg/kg bw.
Other routes:
Intraperitoneal injection of an aqeous solution of the test substance (10.000 mg/kg bw) into mice did not result in mortalities. Intra-abdominal deposits of test substance and conglutinations were observed during necropsy.
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. As a result, the substance is not considered to be classified for acute oral, inhalation or dermal toxicity under Regulation (EC) No. 1272/2008, as amended for the fourteenth time in Regulation (EC) No. 2020/217.
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