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EC number: 911-915-8 | CAS number: -
- 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
In chronic toxicity studies amine fluorides (mixture of 1.315 % Olaflur as leading substance and 0.347 % Hetaflur) were administered to Long-Evans rats and to Beagle dogs, respectively. For the two tested species the NOAEL was considered to be 1 mg/kg bw/day, both for males and females.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 1 mg/kg bw/day
Additional information
Olaflur was not tested for oral repeated dose toxicity as pure substance. Instead a read-across approach was performed with test substance Amine fluoride 297/242, a mixture consisting of Olaflur (Amine fluoride 297) and Hetaflur (Amine fluoride 242), a structural analogue of Olaflur, at a ratio of about 3.8 : 1.
Chronic, oral (rat):
In a chronic toxicity study amine fluorides (mixture of 1.315 % Olaflur as leading substance and 0.347 % Hetaflur) were administered to 70 Long-Evans rats per sex per dose in diet at dose levels of 0, 1, 5 or 25 mg/kg bw/day for a period of 2 years (Menley & James Laboratories, 1975). The NOEL was considered to be 1 mg/kg bw/day for both males and females.
No fatalities occurred during the study. From 6 months after study begin onwards, some of the animals of the 5 and 25 mg/kg bw/d groups showed stiffening of several joints of the fore or hind paws, and of knees and tails, indicating a beginning osteosclerosis. An increase in the leucocyte count was found in male rats of the high-dose group, and – to a lesser extent – in the females of the same group. A dose-dependent enlargement of the mesenteric lymph nodes and yellowish discoloration of the small intestines were seen in the 5 and 25 mg/kg bw/day groups, indicating hypertrophy of the reticulo-endothelial system in response to phagocytosis of the amine fluorides at the site of their absorption.
Chronic, oral (dog):
In a chronic toxicity study amine fluorides (mixture of 1.315 % Olaflur as leading substance and 0.347 % Hetaflur) were administered orally per intubation to 6 Beagle dogs per sex per dose at dose levels of 0, 1, 5 or 25 (10) mg/kg bw/day for a period of 2 years ( Menley & James Laboratories, 1975). The NOEL was considered to be 1 mg/kg bw/day for both males and females.
After 5 weeks, the high dose (25 mg/kg bw/day) was reduced to 10 mg/kg bw/day because of intolerance. Animals of the high and middle dose group showed reduced body weight gains. At the end of treatment slightly lower serum phosphate levels were determined as compared to the controls. On dissection, a yellowish discoloration and hyperplasia/hypertrophy of the reticulo-endothelial system was seen. No other macroscopic or microscopic changes were found in the organs and tissues.
Chronic, dermal:
No studies are available to assess toxicity after repeated dermal exposure, however DNELs can be derived for oral toxicity studies.
Chronic, inhalation:
No studies are available to assess toxicity after repeated inhalation exposure, however DNELs can be derived for oral toxicity studies.
Justification for classification or non-classification
Amine fluorides containing Olaflur as leading substance did not induce adverse effects indicative of serious damage at dose levels relevant for classification and labelling when tested for oral repeated dose toxicity. Therefore the test item is not subject to classification and labelling for repeated dose toxicity according to Directive 67/548/EEC (DSD) and Regulation (EC) No. 1272/2008 (CLP).
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