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EC number: 816-285-7 | CAS number: 1263133-33-0
- 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
Immunotoxicity
Administrative data
Description of key information
28-Day Rat Diet NOAEL (systemic toxicity): 500 ppm, NOAEL (humoral immune response): 6000 ppm; no humoral immune response. EPA OPPTS 870.7800; Reliability = 1
Key value for chemical safety assessment
Effect on immunotoxicity: via oral route
Link to relevant study records
- Endpoint:
- immunotoxicity: acute oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.7800
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rat
- Strain:
- other: Crl:CD(SD)
- Sex:
- female
- Route of administration:
- oral: feed
- Vehicle:
- other: LLC Certified Rodent LabDiet® 5002
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- At least 28 days
- Dose / conc.:
- 100 ppm
- Remarks:
- (8.8 mg/kg bw/d)
- Dose / conc.:
- 500 ppm
- Remarks:
- (41 mg/kg bw/d)
- Dose / conc.:
- 2 000 ppm
- Remarks:
- (166 mg/kg bw/d)
- Dose / conc.:
- 6 000 ppm
- Remarks:
- (474 mg/kg bw/d)
- No. of animals per sex per dose:
- 10 female animals/dose
- Control animals:
- yes, concurrent vehicle
- Positive control:
- cyclophosphamide monohydrate
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- - Adverse, test substance-related effects were observed on body weight and body weight gains in female rats fed ≥2000 ppm.
- The overall body weight gain (test Day 1-29), when compared to the control group for female rats fed 2000, and 6000 ppm, was 73 and 69% of the control, respectively. The reduction in overall body weight gain for the 2000 and 6000 ppm groups corresponded to a 91 and 88% reduction in mean body weight. These effects in body weight and body weight gain were considered test substance-related and adverse due to the magnitude of change. - Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- - Adverse, test substance-related effects on food consumption were observed in female rats fed ≥2000 ppm. Statistically significant decreases were observed in rats fed 2000 ppm during interval Days 15-22 and 22-29 and 6000 ppm throughout the study (all statistically significant).
- Mean overall daily food consumption (test Day 1-29) in 2000 and 6000 ppm was 92% and 85% of the control, respectively. - Food efficiency:
- effects observed, treatment-related
- Description (incidence and severity):
- - Adverse effects on food efficiency was observed in female rats fed 2000 and 6000 ppm of test substance. Mean overall daily food efficiency (test Day 1-29) in 2000 and 6000 ppm groups was 79% and 81% of the control, respectively.
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Humoral immunity examinations:
- no effects observed
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- Humoral Immune response
- Effect level:
- 6 000 ppm
- Sex:
- female
- Basis for effect level:
- other: Based on the lack of test substance-related effects on humoral immune function in female rats at any dietary concentration tested
- Remarks on result:
- other: 6000 ppm is equivalent to 474 mg/kg bw/day in female rats
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- systemic toxicity
- Effect level:
- 500 ppm
- Sex:
- female
- Basis for effect level:
- body weight and weight gain
- food consumption and compound intake
- food efficiency
- Remarks on result:
- other: 500 ppm is equivalent to 41 mg/kg bw/d in female rats
- Conclusions:
- Test substance is not considered to be an immunotoxicant.
- Executive summary:
The study was conducted according to guideline U.S. EPA OPPTS 870.7800 to evaluate the potential of test substance to suppress the primary humoral immune response to sheep red blood cells (sRBC) when incorporated into nutritionally adequate diet and fed to female rats for at least 28 days. The dietary route of administration was selected because it is a potential route of human exposure. Groups of 10 female rats were administered the test substance at dietary levels of 0, 100, 500, 2000, or 6000 ppm. Body weights, food consumption measurements, and clinical observations were recorded during the in-life period. Prior to sacrifice, the immune system was stimulated by injecting sRBC on test Day 24 and blood samples were collected from each rat on test Day 29. The serum samples were assayed for their concentrations of sRBC-specific IgM antibodies to provide a quantitative assessment of humoral immune response. Serum from animals challenged with a positive control immunosuppressive agent was analyzed concurrently to provide confirmation that the assay performance was acceptable for detection of immunosuppression. At sacrifice, each animal was examined grossly and selected organs were weighed (brain, spleen, and thymus).
Samples of the test diets were analyzed, and the results indicated that the test substance was at the targeted concentrations, homogeneously mixed, and stable under the conditions of the study. The overall mean daily intake of test substance was calculated to be 0, 8.8, 41, 166, and 474 mg/kg body weight (bw)/day for the 0, 100, 500, 2000, and 6000 ppm concentrations, respectively.
Adverse effects on body weight, body weight gain and nutritional parameters were observed in female rats fed 2000 and 6000 ppm. No clinical signs of systemic toxicity were observed. No test substance-related effects were observed on gross pathology, absolute and relative brain, spleen, and thymus weights and humoral immune response.
The no-observed-adverse-effect level (NOAEL) for test substance humoral immune response was 6000 ppm, the highest dietary concentration tested. This concentration is equivalent to 474 mg/kg bw/day in female rats. This NOAEL was based on the lack of test substance-related effects on humoral immune function in female rats at any dietary concentration tested.
The NOAEL for test substance systemic toxicity was 500 ppm. This NOAEL was based on reductions in body weight, body weight gains and nutritional parameters in female rats fed ≥2000 ppm test substance.
Under the conditions of this study, test substance is not considered to be an immunotoxicant.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Effect on immunotoxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Effect on immunotoxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
A 28-day immunotoxicity study was conducted with the test substance in female rats up to and including a maximum dietary concentration of 6000 ppm (equivalent to 474 mg/kg bw/day). Selection of the species, sex, and maximum exposure concentration were based on inputs from the U.S. EPA (U.S. EPA Memorandum June 10, 2014, DPX-RAB55: Report of the Dose Adequacy Review Team (DART) – Dose Selection for Immunotoxicity Study, PC Code 129210, DP Barcode 419857, Decision No. 490530). Dietary exposure to the test substance produced no treatment-related effects on thymus or spleen weight or on the antibody response to sheep red blood cells. Test substance related reductions in body weight, mean body weight gain and food efficiency were observed over the 28-day interval at 2000 and 6000 ppm. Based on these results, there is no evidence that the test substance induces toxicity to the immune system.
Justification for classification or non-classification
The test substance did not produce a humoral response in rats or mice in immunotoxicity studies. Therefore, the substance does not need to be classified for immunotoxicity according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) 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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