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EC number: 258-380-0 | CAS number: 53126-67-3
- 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
In a combined repeated dose oral gavage toxicity study with the reproduction/developmental toxicity screening with the structural analogue dibutyl phosphate the No-Observed-Adverse-Effect Level (NOAEL) for general toxicity was considered to be 30 mg/kg bw/day.
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
- Justification for type of information:
- ANALOGUE APPROACH JUSTIFICATION
Please refer to the attached read across justification in section 13. - Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Version / remarks:
- 1996
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 30 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: damgae to digestive tract mucosa, bladder mucosa and effects in liver
- Key result
- Critical effects observed:
- no
- Conclusions:
- The NOAEL for systemic toxicity was determined to be 30 mg/kg bw/day.
- Executive summary:
In order to investigate the toxicity of the read across substance (CAS 107-66-4) after repeated administration a combined repeated dose toxicity and reproductive toxicity study was undertaken using SD (Crj:CD(SD)) rats. There were 10 male and 10 female rats per group, and the test item doses were 0 (control: solvent administered), 30, 100, 300 and 1000 mg/kg bw/day, administered by forced oral administration every day from 14 days prior to the start of mating, until day 3 of lactation after delivery for the females (40-51 days), and for 44 days for the males. The results obtained were as follows: For the parental males, no effects of test item administration were observed in the 30 mg/kg bw/day group. In the 100 mg/kg bw/day and higher dose groups, epithelial hyperplasia with degeneration and ulceration were observed in the bladder mucosa, and red urine excretion and urine-stained lower abdominal fur were also observed. Food consumption decreased in the early stage of dosing. In the 300 mg/kg bw/day and higher dose groups, thickening of the mucosa due to epithelial hyperkeratosis and hyperplasia were observed in the forestomach, and there were also cases of erosion and ulceration of the glandular stomach mucosa and of the thickened forestomach mucosa. In the 1000 mg/kg bw/day group, distended caecum with epithelial degeneration was observed, bodyweight increase was inhibited, and there were deaths.In the parental females (in the 100, 300 mg/kg bw/day and higher dose groups) there was damage to the bladder and gastric mucosa as seen in the parental males; in the 1000 mg/kg bw/day group there were also deaths, and in addition, in the 1000 mg/kg bw/day group there was hepatocyte enlargement and increased liver weight. Also, in the 100 mg/kg bw/day and higher dose groups there were parental females whose pups all died during or after delivery. These parental females also exhibited erosion and ulceration of the gastric mucosa, and fatty hepatocytes, adrenocortical cell vacuolation, etc., were also observed.
From these results it was concluded that the main repeated dose toxicity in the parental animals was damage to the digestive tract, particularly the gastric mucosa and bladder mucosa, and the liver was also affected. The no-effect dose for general toxicological effects was determined to be 30 mg/kg bw/day, for males and females. This value was also determined to be the no-observed-adverse-effect level (NOAEL).
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 30 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- GLP and Guideline study
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
In order to investigate the toxicity of the read across substance (CAS 107-66-4) after repeated administration a combined repeated dose toxicity and reproductive toxicity study was undertaken using SD (Crj:CD(SD)) rats. There were 10 male and 10 female rats per group, and the test item doses were 0 (control: solvent administered), 30, 100, 300 and 1000 mg/kg bw/day, administered by forced oral administration every day from 14 days prior to the start of mating, until day 3 of lactation after delivery for the females (40-51 days), and for 44 days for the males. The results obtained were as follows: For the parental males, no effects of test item administration were observed in the 30 mg/kg bw/day group. In the 100 mg/kg bw/day and higher dose groups, epithelial hyperplasia with degeneration and ulceration were observed in the bladder mucosa, and red urine excretion and urine-stained lower abdominal fur were also observed. Food consumption decreased in the early stage of dosing. In the 300 mg/kg bw/day and higher dose groups, thickening of the mucosa due to epithelial hyperkeratosis and hyperplasia were observed in the forestomach, and there were also cases of erosion and ulceration of the glandular stomach mucosa and of the thickened forestomach mucosa. In the 1000 mg/kg bw/day group, distended caecum with epithelial degeneration was observed, bodyweight increase was inhibited, and there were deaths. In the parental females (in the 100, 300 mg/kg bw/day and higher dose groups) there was damage to the bladder and gastric mucosa as seen in the parental males; in the 1000 mg/kg bw/day group there were also deaths, and in addition, in the 1000 mg/kg bw/day group there was hepatocyte enlargement and increased liver weight. Also, in the 100 mg/kg bw/day and higher dose groups there were parental females whose pups all died during or after delivery. These parental females also exhibited erosion and ulceration of the gastric mucosa, and fatty hepatocytes, adrenocortical cell vacuolation, etc., were also observed.
From these results it was concluded that the main repeated dose toxicity in the parental animals was damage to the digestive tract, particularly the gastric mucosa and bladder mucosa, and the liver was also affected. The no-effect dose for general toxicological effects was determined to be 30 mg/kg bw/day, for males and females. This value was also determined to be the no-observed-adverse-effect level (NOAEL).
Justification for classification or non-classification
Classification,
Labelling, and Packaging Regulation (EC) No 1272/2008
The
available experimental test data are reliable and suitable for
classification purposes under Regulation (EC) No 1272/2008. Based on
available data on repeated dose toxicity, the
test item is not classified according
to Regulation (EC) No 1272/2008 (CLP), as amended for the twelth
time in Regulation (EU) No 2019/521.
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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