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EC number: 606-826-3 | CAS number: 217308-07-1
- 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
Skin: not irritating (BASF, 2001)
Eye: irritating (BASF, 2016a)
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
The potential of (R)-Ammoniummandelat-Lösung (ca. 30%) to cause acute dermal irritation or corrosion was assessed by a single topical application of 0.5 ml of the test substance to the intact skin of 3 White New Zealand rabbits for 4 hours under semiocclusive dressing. After removal of the patch the application area was washed off. The cutaneous reactions were assessed approximately 1, 24, 48, 72 hours and 7 days after removal of the patch. Slight to moderate erythema was observed in all animals on the day of application, slight erythema persisted in 1 animal up to day 3. No edema was observed. The cutaneous reactions were reversible in all animals within 7 days after removal of the patch at latest. The average score (24 to 72 hours) for irritation was calculated to be 0.3 for erythema and 0.0 for edema. Considering the described cutaneous reactions as well as the average score for irritation, (R)-Ammoniummandelat-Lösung (ca. 30%) does not give indication of an irritant property to the skin under the test conditions chosen (BASF, 2001).
D-(-)-Mandelic acid was tested in an acute dermal irritation/corrosion test (according to OECD 404). No skin reaction was noted at any reading 1, 24, 48, or 82 h after semiocclusive dermal exposure to 0.5 g of the test substance (80% aqueous formulation) for 4 h in any of 3 White Vienna rabbits (BASF 1987).
Even under worst case conditions using mandelic acid, no skin reactionwas observed. Therefore, Benzeneacetic acid, .alpha.- hydroxy-, monoammonium salt, (.alpha.R) does not pose a skin irritating potential.
Eye Irritation
Several studies are available for Benzeneacetic acid, .alpha.- hydroxy-, monoammonium salt, (.alpha.R). A study (OECD 405) with the 30% aqueous solution of (R)-Ammoniummandalte does not give indication of an irritant property to the eye under the test conditions chosen (BASF, 2001). To assess the properties of the pure substance, an in vitro test (BCOP) was performed using dried test substance. This test gave a borderline result, which does not clearly allow the evaluation of the risk to cause serious eye damage. Based on the observed results and applying the evaluation criteria it was concluded, that the results of the test substance Benzeneacetic acid, .alpha.- hydroxy-, monoammonium salt, (.alpha.R)- (dried) have to be considered “inconclusive” in the Bovine Corneal Opacity and Permeability Test (BCOP Test) under the test conditions chosen (BASF, 2016a). To perform a final assessment an additional OECD 405 guideline study was performed also with the dried test substance (saturated solution, BASF, 2016b).
The potential of Benzeneacetic acid, .alpha.-hydroxy-, monoammonium salt, (.alpha.R)- (dried) to cause ocular irritation or serious damage to the eyes (BCOP, OECD 437) was assessed by a single topical application of 750μL of a 20% test-substance preparation to the epithelial surface of isolated bovine corneas.Three corneas were treated with the test-substance preparation for an exposure period of 4 hours.
The mean In Vitro Irritancy Score was 59.7. The borderline result do not clearly allow for the evaluation of risk of serious eye damage. On basis of the results of this study a potential of the test substance to bear a risk of serious eye damage cannot be excluded.
Based on the observed results and applying the evaluation criteria it has to be concluded, that the results of the test substance Benzeneacetic acid, .alpha.- hydroxy-, monoammonium salt, (.alpha.R)- (dried) should be considered “inconclusive” in the Bovine Corneal Opacity and Permeability Test (BCOP Test) under the test conditions chosen (BASF, 2016a). For final assignment of a risk phrase at present, results from another study would be needed.
The potential of Benzeneacetic acid, .alpha.-hydroxy-, monoammonium salt, (.alpha.R)- (dried) to cause damage to the conjunctiva, iris or cornea was assessed by a single ocular application of 0.1 mL of the saturated solution of the test item to one eye of three New Zealand White rabbits (stepwise procedure starting with one animal and supplementing two additional animals). About, and not less than 24 hours after application the eye was rinsed with tap water. The ocular reactions were assessed approximately 1, 24, 48 and 72 hours after application and in a weekly interval until day 7. Additional eye examinations were performed following the instillation of a fluorescein solution starting at 24 h after administration until hour 48 in two animals or day 7 in one animal (reversibility of corneal lesions).
Clinical observations were recorded during the course of the study: Slight corneal opacity (grade 1), moderate iritis (grade 1), slight to obvious conjunctival redness (grade 1-2), slight to moderate conjunctival chemosis (grade 1-2), slight to severe discharge (grade 1-3), additional findings like desquamation of corneal epithelium, corneal lesions detected with the aid of fluorescein (grade 1, 2 and 4) and injected scleral vessels in a circumscribed or circular area were noted in the animals within 7 days after application. The ocular reactions were reversible in all animals within 7 days after application. Mean scores calculated for each animal over 24, 48 and 72 hours were 1.0, 0.0 and 0.0 for corneal opacity, 0.3, 0.0 and 0.0 for iris lesions, 2.0, 1.0 and 2.0 for redness of the conjunctiva and 1.3, 1.0 and 1.7 for chemosis.
Considering the described ocular reactions as well as the average score for irritation, Benzeneacetic acid, .alpha.-hydroxy-, monoammonium salt, (.alpha.R)- (dried) shows an eye irritating potential under the test conditions chosen. (BASF, 2016b)
The potential of (R)-AmmoniummandeIat-Lösung (ca. 30%) to cause damage to the conjunctiva, iris or cornea was assessed in 3 White New Zealand rabbits, subjected to a single ocular application of 0.1 ml of the test substance. About 24 hours after application the eye was rinsed with tap water. The ocular reactions were assessed approximately 1, 24, 48 and 72 hours after application. Slight to moderate conjunctival redness was observed in the animals up to 48 hours after application. Additionally slight conjunctival swelling was noted in 1 animal and slight discharge in 2 animals on the day of application. No other ocular findings were noted. The ocular reactions were reversible in all animals within 72 hours after application at latest. The average score (24 to 72 hours) for irritation was calculated to be 0.0 for corneal opacity, iris and chemosis and 0.4 for conjunctival redness.Considering the described ocular reactions as well as the average score for irritation, (R)-AmmoniummandeIat-Lösung (ca.30%) does not give indication of an irritant property to the eye under the test conditions chosen (BASF, 2001).
Justification for selection of skin irritation / corrosion endpoint:
key study
Justification for selection of eye irritation endpoint:
Key study
Effects on eye irritation: irritating
Justification for classification or non-classification
Based on the results of the eye irritation testing, the test item is classified as eye irritant cat. 2 (H319) according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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