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Diss Factsheets
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EC number: 297-701-9 | CAS number: 93686-48-7
- 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
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Threshold values derivation:
In this section, data from all end-points are examined and analyzed in order to determine for which it is relevant and possible to establish a DNEL value. The method followed is that proposed in the guidance for the implementation of REACH (Chapter R.8: Characterization of dose (concentration) -response for human health, November 2012).
1. Acute / short-term exposure - systemic effects
Because no systemic effects were seen in any of the studies registered for phosphorous acid tri-C12 -14 -alkyl esters or triisodecyl phosphite as read across, and no acute toxicity hazard has been identified,it is not relevant to derive any DNEL for systemic effect.
2. Acute / short-term exposure - local effects
Cutaneous/ eye route
None of the available studies registered by dermal or inhalation routes provide relevant dose response data on irritation/ corrosion symptoms. That is why no DNEL could be derived for these endpoints, and a more qualitative approach was investigated:
Phosphorous acid, tri-C12-14-alkyl esters was tested in vivo for skin and eye irritation using OECD 404/ 405 test guidelines, but studies were not performed under GLP conditions. No deviation to the guidelines was noted and the studies were considered as reliable but quoted with reliability 2.
For skin irritation; three New Zealand white rabbits were tested with 0,5 mL pure test item and scoring was performed at 1, 24, 48 and 72 hour.
Slight erythema well defined were noted for 3 animals and very slight oedema on 2 animals after 24h observation. All were fully reversible within 6 days.
For eye irritation; three New Zealand white rabbits were tested with 0,1 mL pure test item and scoring was performed at 1, 24, 48 and 72 hour.
Slight conjunctivae effects were noted on 3 animals 1 hour after instillation (enanthema slight to moderate with slight chemosis) and were fully reversible within 48h after treatment.
In the two cases, no other clinical or systemic signs were noted.
With a primary skin irritation index of 1,8, and maximum mean irritation score of 9.3 for eyes, Phosphorous acid, tri-C12-14-alkyl esters was considered as slightly irritant for skin and eyes, according to French protocol and scaling but not classified according to GHS criteria.
In these conditions, no qualitative assessment is needed for Phosphorous acid, tri-C12-14-alkyl esters and good industrial hygiene practices are considered sufficient to ensure safety of workers. Moreover, a low hazard category could be used for a more proctective approach, but the sensitizing potential of Phosphorous acid, tri-C12-14-alkyl esters (see below the study summary) is the leading health effect for dermal route and its moderate hazard category associated covers the slight irritation effects showed in the rabbit studies. The risk managment measures and operational conditions linked with a moderate hazard would be then sufficient.
Inhalation
Triisodecyl phosphite used for read across was given to rats during the one-hour exposure period at the concentration of 12.6 mg/L air. Because neither adverse effects nor untoward signs and symptoms were observed during the 21-day post-exposure observation period, no threshold value could be derived for inhalation following acute exposure.
3. Long-term exposure - systemic effects
Because no systemic effects were seen in any of the studies registered for Phosphorous acid, tri-C12-14-alkyl esters
or triisodecyl phosphite as read across (combined repeated dose and reproductive toxicity study), and neither acute nor repeated toxicity hazard has been identified,it is not relevant to derive any DNEL based on these data. But sensitizing potential of the submitted substance could be taken into account for systemic effects as for local effects (point of contact of the substance on skin) and a qualitative assessment is therefore done : see the paragraph just below.
4. Long-term exposure - local effects
Cutaneous/eye route
As already described for short term exposure, no assessment is needed for Phosphorous acid, tri-C12-14-alkyl esters due to irritation/ corrosion effects.
But Phosphorous acid, tri-C12-14-alkyl esters was tested in a LLNA test for sensitization. The study followed the current guidelines and the small deviation did not affect the validity that was quoted to reliability 1 according to Klimlisch criteria.
Three groups each of four female mice were treated once daily with the test item at concentrations of 5, 10, and 25% (w/v) in acetone:olive oil (4+1, v/v) by topical application to the dorsum of each ear for three consecutive days. The highest concentration btested was the highest concentration that could be achieved whilst avoiding systemic toxicity and excessive local skin irritation as confirmed by a pre-experiment.
All treated animals survived the scheduled study period and no signs of systemic toxicity or local skin irritation were observed.
In this study Stimulation Indices of 1.00, 1.45 and 3.42 were determined with the test item at concentrations of 5, 10, and 25% (w/v) in acetone:olive oil (4+1, v/v). A clear dose response was observed. The EC3 value calculated was 21.8%, which indicates a moderate sensitizing potential.
As recommended in the guidance for the implementation of REACH (Chapter R.8: Characterization of dose (concentration) -response for human health, November 2012), the general approach to sensitizers could be viewed as a two-step procedure involving;
1. a qualitative approach (by using potency categorisation and following the approach described in Section E.3.4 to define the risk management measures (RMMs) and operational conditions (OCs),
2. and setting a DNEL (if possible) to judge the remaining/residual likelihood of risks after these RMMs and OCs are implemented
The qualitative approach aims at reducing/avoiding contact with the substance. However, implementation of risk management measures (RMMs) and operational conditions (OCs) needs to be proportional to the degree of concern for the health hazard presented by the substance. The purpose of this qualitative approach is to minimize the exposure considering the level of risk related to the hazard properties of the substance (indicated by R-phrases).
For a moderate sensitizer as Phosphorous acid, tri-C12-14-alkyl esters, the medium hazard category is allocated on the basis that exposure should be adequately minimized.
This qualitative approach is considered as more relevant that deriving a DNEL from the EC3 value, which could result in an unrealistic to low value of substance/ µg/ cm²/ day, due to the considerable variability in determining each appropriate assessment factor.
Inhalation
Triisodecyl phosphite used for read across was given to rats during the one-hour exposure period at the concentration of 12.6 mg/L air. Neither adverse acute effects nor local symptoms were observed during the 21-day post-exposure observation period. This substance was also tested by oral route in a combined repeated dose and reproductive toxicity study and showed that no effect due to the administration of triisodecyl phosphite. No threshold value could be then derived for repeated exposure by inhalation.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
See discussion for workers.
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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