Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 271-663-3 | CAS number: 68603-55-4
- 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
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
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Refer to the section 13 of IUCLID dataset for details on the read across justification. The combined repeated dose and reproductive-developmental toxicity screening study with the read across substance is considered sufficient to fulfil the information requirements as further explained in the provided endpoint summary
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 421
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Accuracy, homogeneity and stability of formulations were demonstrated by analyses.
- Duration of treatment / exposure:
- Males - 29 d and females - 41-54 d
- Frequency of treatment:
- Once daily
- Dose / conc.:
- 10 mg/kg bw/day (actual dose received)
- Remarks:
- Based on the results of a 14-day dose range finding study (Project 499977; BASF Project 01R0613/11X493) the dose levels for this combined 28-day oral gavage study with reproduction/developmental toxicity screening test were selected to be 10, 30 and 100 mg/kg bw/day.
- Dose / conc.:
- 30 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 100 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- After acclimatization, four groups of ten male and ten female Wistar Han rats were exposed by oral gavage to the test substance at 0, 10, 30 and 100 mg/kg/day. Males were exposed for 29 days, i.e. 2 weeks prior to mating, during mating, and up to termination. Females were exposed for 41 - 54 days, i.e. during 2 weeks prior to mating, during mating, during post-coitum, and during at least 4 days of lactation.
- Observations and examinations performed and frequency:
- The following observations and examinations were evaluated: mortality / viability, clinical signs (daily), functional observations and locomotor activity (Week 4 (males); end of lactation (females)), body weight and food consumption (at least at weekly intervals), clinical pathology (Week 4 (males); end of lactation (females)), macroscopy at termination, organ weights and histopathology on a selection of tissues.
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Details on results:
- Hematological examinations revealed slightly increased leucocyte counts in males and females at 100 mg/kg bw/day, primarily due to increased neutrophil counts. Increased leucocyte counts were also present in females at 30 mg/kg bw/day, and the percentage of neutrophils was increased in both sexes at this dose. No toxicologically relevant changes were observed by clinical chemistry examinations. Spleen weights were moderately increased in both sexes at 100 mg/kg bw/day.
Enlarged spleen was observed in one male and 4 females at 100 mg/kg bw/day. Enlarged mesenteric lymph nodes were present in 5 males and all females at high dose, in 6 females at the mid dose and in 2 females at the low dose. Treatment-related microscopic findings were noted in the mesenteric lymph nodes and adrenal gland cortex (all dose groups). Findings in the mesenteric lymph nodes consisted of:
− foamy macrophages with/without fibrosis (up to a marked degree), which was correlated with enlargement of the mesenteric lymph nodes at necropsy.
− Sinus ectasia (up to a moderate degree) at all doses, which was considered secondary to the occurrence of foamy macrophages.
− Focal necrosis within the aggregates of foamy macrophages with/without fibrosis of males at all doses and in females at the mid and high dose
− Macrophage foci up to a moderate degree (females) or marked degree (males) at all doses.
The lesions in the adrenal cortex consisted of inflammatory lymphocytic cells (up to a slight degree) in females at all doses. - Key result
- Dose descriptor:
- LOAEL
- Effect level:
- 10 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- gross pathology
- haematology
- histopathology: non-neoplastic
- organ weights and organ / body weight ratios
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 10 mg/kg bw/day (actual dose received)
- System:
- haematopoietic
- Organ:
- adrenal glands
- mesenteric lymph node
- spleen
- Treatment related:
- yes
- Dose response relationship:
- yes
- Conclusions:
- Under the study conditions, no NOAEL could be determined for parental systemic toxicity and hence the LOAEL for systemic toxicity was determined to be 10 mg/kg bw/day
- Executive summary:
A study was conducted to determine the repeated dose toxicity potential of the read-across substance amines, C11 -14 -branched alkyl, monohexyl and dihexyl phosphates according to OECD Guideline 422, 421 and 407 and EU Method B.7, under GLP conditions. Four groups of ten male and ten female Wistar Han rats were exposed by oral gavage to the test substance at 0, 10, 30 and 100 mg/kg bw/day. Males were exposed for 29 d, i.e. 2 weeks prior to mating, during mating, and up to termination. Females were exposed for 41 - 54 d, i.e. during 2 weeks prior to mating, during mating, during post-coitum, and during at least 4 d of lactation. The following observations and examinations were evaluated: mortality / viability, clinical signs (daily), functional observations and locomotor activity (Week 4 (males); end of lactation (females)), body weight and food consumption (at least at weekly intervals), clinical pathology (Week 4 (males); end of lactation (females)), macroscopy at termination, organ weights and histopathology on a selection of tissues, and reproduction/developmental parameters, consisting of mating, fertility and conception indices, precoital time, number of corpora lutea and implantation sites, gestation index and duration, parturition, maternal care, sex ratio and early postnatal pup development (mortality, clinical signs, body weights and macroscopy). Formulations were analyzed once during the study to assess accuracy, homogeneity and stability. No clinical signs of toxicity were observed in the parental animals. Body weight development and food consumption were not affected by administration of the test substance. Hematological examinations revealed slightly increased leucocyte counts in males and females at 100 mg/kg bw/day, primarily due to increased neutrophil counts. Increased leucocyte counts were also present in females at the mid dose and the percentage of neutrophils was increased in both sexes at this dose. No toxicologically relevant changes were observed by clinical chemistry examinations. Enlarged spleen with increased weight was observed at the high dose only. Histopathological findings were confined to lesions in the mesenteric lymph nodes (foamy macrophages with/without fibrosis, sinus ectasia, focal necrosis within the aggregates of foamy macrophages with/without fibrosis and macrophage foci) and adrenal gland cortex (inflammatory lymphocytic cells). The higher neutrophil counts (and white blood cell counts) at 30 and 100 mg/kg bw/day were considered to be due to these inflammatory histopathological changes. No treatment-related changes were noted in any of the reproductive parameters investigated in this study. Histopathologically, the assessment of the integrity of the spermatogenetic cycle did not provide any evidence of impaired spermatogenesis, and no abnormalities were seen in the reproductive organs of the animal that failed to deliver healthy offspring. Finally, no treatment-related changes were noted in any of the developmental parameters investigated in this study. Under the study conditions, no NOAEL could be determined for parental systemic toxicity and hence the LOAEL for systemic toxicity was determined to be 10 mg/kg bw/day (van Otterdijk, 2013).
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LOAEL
- 10 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- System:
- haematopoietic
- Organ:
- adrenal glands
- mesenteric lymph node
- spleen
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
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
A study was conducted to determine the repeated dose toxicity potential of the read-across substance amines, C11 -14 -branched alkyl, monohexyl and dihexyl phosphates according to OECD Guideline 422, 421 and 407 and EU Method B.7, under GLP conditions. Four groups of ten male and ten female Wistar Han rats were exposed by oral gavage to the test substance at 0, 10, 30 and 100 mg/kg bw/day. Males were exposed for 29 d, i.e. 2 weeks prior to mating, during mating, and up to termination. Females were exposed for 41 - 54 d, i.e. during 2 weeks prior to mating, during mating, during post-coitum, and during at least 4 d of lactation. The following observations and examinations were evaluated: mortality / viability, clinical signs (daily), functional observations and locomotor activity (Week 4 (males); end of lactation (females)), body weight and food consumption (at least at weekly intervals), clinical pathology (Week 4 (males); end of lactation (females)), macroscopy at termination, organ weights and histopathology on a selection of tissues, and reproduction/developmental parameters, consisting of mating, fertility and conception indices, precoital time, number of corpora lutea and implantation sites, gestation index and duration, parturition, maternal care, sex ratio and early postnatal pup development (mortality, clinical signs, body weights and macroscopy). Formulations were analyzed once during the study to assess accuracy, homogeneity and stability. No clinical signs of toxicity were observed in the parental animals. Body weight development and food consumption were not affected by administration of the test substance. Hematological examinations revealed slightly increased leucocyte counts in males and females at 100 mg/kg bw/day, primarily due to increased neutrophil counts. Increased leucocyte counts were also present in females at the mid dose and the percentage of neutrophils was increased in both sexes at this dose. No toxicologically relevant changes were observed by clinical chemistry examinations. Enlarged spleen with increased weight was observed at the high dose only. Histopathological findings were confined to lesions in the mesenteric lymph nodes (foamy macrophages with/without fibrosis, sinus ectasia, focal necrosis within the aggregates of foamy macrophages with/without fibrosis and macrophage foci) and adrenal gland cortex (inflammatory lymphocytic cells). The higher neutrophil counts (and white blood cell counts) at 30 and 100 mg/kg bw/day were considered to be due to these inflammatory histopathological changes. No treatment-related changes were noted in any of the reproductive parameters investigated in this study. Histopathologically, the assessment of the integrity of the spermatogenetic cycle did not provide any evidence of impaired spermatogenesis, and no abnormalities were seen in the reproductive organs of the animal that failed to deliver healthy offspring. Finally, no treatment-related changes were noted in any of the developmental parameters investigated in this study. Under the study conditions, no NOAEL could be determined for parental systemic toxicity and hence the LOAEL for systemic toxicity was determined to be 10 mg/kg bw/day (van Otterdijk, 2013).
Justification for classification or non-classification
Based on the combined repeated dose toxicity and reproductive-developmental toxicity screening study with the read-across substance, no classification is warranted according to EU CLP (EC 1272/2008) criteria.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.