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EC number: 272-940-1 | CAS number: 68921-45-9
- 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
Ecotoxicological Summary
Administrative data
Hazard for aquatic organisms
Freshwater
- Hazard assessment conclusion:
- PNEC aqua (freshwater)
- PNEC value:
- 0.002 mg/L
- Assessment factor:
- 1 000
- Extrapolation method:
- assessment factor
- PNEC freshwater (intermittent releases):
- 0.023 mg/L
Marine water
- Hazard assessment conclusion:
- PNEC aqua (marine water)
- PNEC value:
- 0.002 mg/L
- Assessment factor:
- 1 000
- Extrapolation method:
- assessment factor
- PNEC marine water (intermittent releases):
- 0.023 mg/L
STP
- Hazard assessment conclusion:
- PNEC STP
- PNEC value:
- 100 mg/L
- Assessment factor:
- 10
- Extrapolation method:
- assessment factor
Sediment (freshwater)
- Hazard assessment conclusion:
- PNEC sediment (freshwater)
- PNEC value:
- 59.9 mg/kg sediment dw
- Extrapolation method:
- equilibrium partitioning method
Sediment (marine water)
- Hazard assessment conclusion:
- PNEC sediment (marine water)
- PNEC value:
- 59.9 mg/kg sediment dw
- Extrapolation method:
- equilibrium partitioning method
Hazard for air
Air
- Hazard assessment conclusion:
- no hazard identified
Hazard for terrestrial organisms
Soil
- Hazard assessment conclusion:
- no hazard identified
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- PNEC oral
- PNEC value:
- 0.5 mg/kg food
- Assessment factor:
- 300
Additional information
The studies utilised in the assessment are GLP compliant studies, and have been peer reviewed and evaluated in the context of the OECD SIDS and US HP programme.
Fish:
Read across to CAS 36878 -20 -3. Study conducted to OECD test guidelines in compliance with GLP. LC50 > 10,000 mg/l. This is significantly higher than the water solubility for the substance, but is considered to be an accurate reflection of toxicity to the substance in the event of release.
Daphnia:
To address the acute toxicity to aquatic invertebrates, two saltwater toxicity tests, using mysid shrimp are available; one on the substance itself, and one on a close structural analogue. The results of these are as follows:
CAS 68921-45-9: 96-h LC50 : 2.3 mg/l (1.3-10 mg/l; 95% confidence limits). 96-h NOEC < 1.3 mg/l.
CAS No. 36878-20-3: 96 h EC50: c = 733 mg/l ; 96-h NOEC: c = 250 mg/l (WAF).
It is noted that the preferred study to address this endpoint utilises freshwater daphnia. However, the available data on saltwater species is considered appropriate to address the requirements of Annex XI, Para 1.1.2 as follows:
1) adequacy for the purpose of classification and labelling and/or risk assessment;
The two results available are somewhat different; this is attributed to the dosing methods seen in the experiments. For the purposes of hazard assessment, the value on the substance itself it taken as appropriate, and classification and labelling is applied on this basis. This is therefore considered adequate for risk assessment.
2) adequate and reliable coverage of the key parameters foreseen to be investigated in the corresponding test methods referred to in Article 13(3);
The studies are GLP compliant studies, conducted to recent guidelines. The integrity and results are therefore considered appropriate and are in accordance with the recognised guidelines. There is no documented evidence that saltwater species are more sensitive than freshwater species, although the REACH guidance attributes and additional assessment factor of 10 for risk characterisation calculations.
3) exposure duration comparable to or longer than the corresponding test methods referred to in Article 13(3) if exposure duration is a relevant parameter; and
The exposure duration of the study is in accordance with the guideline method at 96 hours. This is longer than the required 48 hour exposure utilised in the acute toxicity to Daphnia study.
4) adequate and reliable documentation of the study is provided.
The studies are GLP compliant studies, and have been peer reviewed and evaluated in the context of the OECD SIDS and US HP programme. The results are presented as appropriate summaries of the original reports.
The use of these studies results in classification and labelling under the CLP Regulation (EC) No 1272/2008 as follows:
Aquatic Chronic Category 2
H411: Toxic to aquatic life with long lasting effects.
A Daphnia magna reproduction test is available for read-across substance, CAS 10081-67-1. In this study, there were no significant treatment-related effects on survival, reproduction or growth at concentrations ≤38 μg a.i./L. Consequently, the NOEC for reproduction was 38 μg a.i./L and the LOEC was >38 μg a.i./L; these values are welll below the water solubility of the read-across substance ( < 0.0067 mg/L) and also well below the water solubility of this substance (0.706 mg/L)
Algae:
Read across to supporting substance CAS 36878 -20 -3. EC50 = 650 mg/l; NOEC 33 mg/l. Effects were determined to be algistatic based on the rapid re-growth of an aliquot of cells taken from 500 mg/L cultured in fresh control media. However the results do not trigger classification and labelling under the CLP Regulation.
The substance has been supported under Environmental Protection Agency’s (EPA’s) High Production Volume (HPV) Challenge Program. The American Chemical Councils RAPA Panel, has derived a “Substituted Diphenylamines” category of chemicals for this substance, please refer to EPA reference 201-14700A located at http://www.epa.gov/hpv/pubs/summaries/subdipha/c13378rt.pdf
Relying on several factors specified in EPA’s guidance document on “Development of Chemical Categories in the HPV Challenge Program,” in which use of chemical categories is encouraged, the chemicals constitute a chemical category on the following basis:
Structural Similarity. A key factor supporting the classification of these chemicals as a category is their structural similarity (see Figure 1). All share a common starting material; Diphenylamine (Benzenamine, N-phenyl-, CAS# 122-39-4), a common synthetic pathway, and all compounds in this category are diamines with various substitutions.
Similarity of Physicochemical Properties. The similarity of the physicochemical properties of these materials parallels their structural similarity. All are off-white to light brown solids or viscous liquids intended for use as antioxidants in finished rubber articles or as antidegradant additives that extend the useful life of heavy-duty industrial functional fluids used in high-speed, high-temperature and/or high-load applications. As a class, these amine-based antidegradant compounds are less migratory (more polymer-bound) and less staining than the Substituted p-Phenylenediamine antidegradants. The use of these materials requires that they be stable under high temperatures. Their low volatility is due to their low vapor pressure, highly viscous or solid form. The existing information for these materials indicates that they have low water solubility and high flash points.
Fate and Transport Characteristics. Members of this category have been shown to be not readily biodegradable, so additional testing is not needed. The lack of water solubility of the members of this category makes hydrolysis testing unnecessary. These materials have been shown not to partition to water or air if released into the environment due to their low water solubility and low vapor pressure.
Toxicological Similarity. Review of existing published and unpublished test data for Substituted Diphenylamines shows the aquatic and mammalian toxicity among the materials within this category are similar.
Aquatic Toxicology. Data on acute fish toxicity, acute invertebrate toxicity, and alga toxicity were reviewed. With increasing molecular weight, the toxicity to aquatic organisms decreases. These materials have high estimated log Kowvalues, such that acute toxicity is not expected at or below their low levels of water solubility. For the purposes of the HPV Program, additional testing was not proposed for the members of this category.
Conclusion. Based upon the data reviewed in “Substituted Diphenylamines” category of chemicals, the physicochemical and toxicological properties of the Substituted Diphenylamine category members are similar and follow a regular pattern as a result of that structural similarity. Therefore, the definition of a chemical category has been met, and read across is considered appropriate for the category of chemical.
Conclusion on classification
The use of these studies results in classification and labelling under the CLP-Regulation (EC) No 1272/2008 as follows:
Aquatic Chronic Category 2
H411: Toxic to aquatic life with long lasting effects.
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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