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EC number: 267-466-7 | CAS number: 67874-37-7
- 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
Endpoint summary
Administrative data
Description of key information
• Repeat dose oral (OECD 422, read-across): No signs of systemic toxicity or reproductive or developmental effects at any dose level up to, and including, 1000 mg/kg/day.
• Repeat dose dermal: No studies are available
• Repeat dose inhalation: No studies are available
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- Remarks:
- combined repeated dose and reproduction / developmental screening
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- yes
- Remarks:
- This protocol exceeded the OECD 422 study design by following the F1 offspring to adulthood, with continued exposure and assessments of neurologic, immunologic and reproductive structures and functions. The protocol also assessed F0 recovery males, 28-day
- Principles of method if other than guideline:
- Method: Modified
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- Male and female CD (Sprague-Dawley(SD)) F0 rats were administered TDP orally by gavage at 0, 50, 250 and 1000 mg/kg/day at a dose volume of 5 ml/kg/day in Mazola® corn oil, 10 animals/sex/dose, for 2 weeks of prebreed exposure (males and females), 2 weeks of mating (males and females) and 3 weeks of gestation and lactation each (F0 females).
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Homogeneity and stability studies were run on TDP in corn oil at concentrations of 10, 50, and 200 mg/mL (TDP in corn oil). The 50 and 200 mg/mL concentrations were prepared weekly as they were found to be stable. The 10 mg/mL concentration was prepared daily due to stability concerns.
- Duration of treatment / exposure:
- 8 weeks
- Frequency of treatment:
- once per day
- Remarks:
- Doses / Concentrations:
0, 50, 250 and 1000 mg/kg/day
Basis:
actual ingested - No. of animals per sex per dose:
- 10
- Control animals:
- yes
- Details on study design:
- DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: at least once daily for F0 males and females until necropsy.
BODY WEIGHT: Yes
- Time schedule for examinations: F0 males and females weekly during the prebreed period for both sexes and for F0 females during gestation and lactation.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- F0 males and females weekly during the prebreed period for both sexes and for F0 females during gestation and lactation. - Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food efficiency:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Critical effects observed:
- not specified
- Conclusions:
- TDP administered by gavage once daily at 0, 50, 250 and 1000 mg/kg/day to parental F0 CD (SD) rats, 10/sex/group through prebreed, mating, gestation and F1 lactation resulted in essentially no treatment or dose related adult F0 parental toxicity at any dose at any time. Reproductive toxicity was not present in F0 males or females. There was also no F1offspring toxicity observed postnatally through the weanling necropsy. Therefore, the F0 male and female systemic no observable adverse effect level (NOAEL) was at or above 1000mg/kg/day for males and females. The NOAELs for F0 reproductive toxicity were observed at or above 1000 mg/kg/day for males and females. The NOAELs for F1 offspring toxicity during lactation were also at or above 1000 mg/kg/day for males and females. (Author)
- Executive summary:
TDP administered by gavage once daily at 0, 50, 250 and 1000 mg/kg/day to parental F0 CD (SD) rats, 10/sex/group through prebreed, mating, gestation and F1 lactation resulted in essentially no treatment or dose related adult F0 parental toxicity at any dose at any time. Reproductive toxicity was not present in F0 males or females. There was also no F1offspring toxicity observed postnatally through the weanling necropsy. Therefore, the F0 male and female systemic no observable adverse effect level (NOAEL) was at or above 1000mg/kg/day for males and females. The NOAELs for F0 reproductive toxicity were observed at or above 1000 mg/kg/day for males and females. The NOAELs for F1 offspring toxicity during lactation were also at or above 1000 mg/kg/day for males and females.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Dose descriptor:
- NOAEL
- 5 000 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Additional information
Use of data on a closely related analog, triisodecyl phosphite (TDP), has been selected to represent the repeat-dose toxicity of PDiTDP. Based on similar toxicity on other mammalian endpoints it appears appropriate to use TDP repeat-dose toxicity data to read-across to PDiTDP. In addition, the OECD- accepted category approach for the C10 and C13 isoalkyl alcohols, hydrolysis products of TDP and PDiTDP, respectively, further supports this read-across approach. See justification document in Section 13.
An enhanced combined repeat-dose and reproductive and developmental effects study was performed on TDP. This study was conducted in rats via oral gavage and included evaluations of systemic toxicity and neurotoxicity in both the F0 and F1 generations in addition to evaluations of reproductive performance and developmental effects.
TDP administered by gavage once daily at 0, 50, 250 and 1000 mg/kg/day to parental F0 CD (SD) rats, 10/sex/group through prebreed, mating, gestation and F1 lactation resulted in essentially no treatment or dose related adult F0 parental toxicity at any dose at any time. Reproductive toxicity was not present in F0 males or females. There was also no F1offspring toxicity observed postnatally through the weanling necropsy. Therefore, the F0 male and female systemic no observable adverse effect level (NOAEL) was at or above 1000mg/kg/day for males and females. The NOAELs for F0 reproductive toxicity were observed at or above 1000 mg/kg/day for males and females. The NOAELs for F1 offspring toxicity during lactation were also at or above 1000 mg/kg/day for males and females.
The inhalation and dermal NOAELs were extrapolated from the oral study using standard route-to-route extrapolations and assuming 50% oral and inhalation absorption and 10% dermal absorption.
The following information is taken into account for any hazard / risk assessment:
In a study on an analog substance, triisodecyl phosphite (TDP), there were no signs of systemic toxicity or reproductive or developmental effects at any dose level up to, and including, 1000 mg/kg/day.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
The repeat dose toxicity of PDiTDP via the oral route has been read-across from a study conducted with the closely related analogue TDP. The study was conducted according to OECD Guideline 422 and to GLP and is adequately reported. Justification for read across to TDP is provided in Section 13.
Justification for selection of repeated dose toxicity dermal - systemic effects endpoint:
Extrapolation from oral repeat-dose study.
Justification for classification or non-classification
The repeated dose toxicity of TiTDP via the oral route has been read-across from the closely related analogue TDP based on the following study: No systemic toxicological findings were detected in rats after repeated administration of TDP by the oral route at dose levels up to 1000 mg/kg bw/day. Therefore, classification of the TDP as STOT RE is not justified under the conditions of this test. As such, it can be considered that classification of TITDP is also not justified according to the criteria described in Regulation (EC) No 1272/2008.Justification for read across to TDP is provided in Section 13.
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