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EC number: 627-085-2 | CAS number: 1238449-42-7
- 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
The test item was tested in a repeated-dose 28 -day toxicity study according to OECD guideline no. 407. The oral administration of test item via diet over a period of 4 weeks revealed pathological findings in male Wistar rats at a concentration of 15000 ppm. Therefore, under the conditions of the present study the no observed adverse effect level (NOAEL) was 415 mg/kg bw/d (5000 ppm) in male and 1351 mg/kg bw/d (15000 ppm) in female Wistar rats.
Furthermore, the test item was tested in a repeated-dose 90 -day toxicity study according to OECD guideline no. 408. The oral administration of test item via diet over a period of 13 weeks revealed pathological findings in male Wistar rats at a concentration of 1000 mg/kg. Therefore, under the conditions of the present study the no observed adverse effect level (NOAEL) was 356 mg/kg bw/d in male and 1166 mg/kg bw/d in female Wistar rats.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 356 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- OECD guideline was followed.
GLP study
Additional information
The test item was tested in a repeated-dose 28 -day toxicity study according to OECD guideline no. 407 and EU method B.7. The test item was administered via the diet to groups of 5 male and 5 female Wistar rats at concentration levels of 0 ppm (maintenance diet served as vehicle control; test group 0), 1500 ppm (test group 1), 5000 ppm (test group 2) and 15000 ppm (test group 3) over a period of 4 weeks. Food consumption and body weight were determined weekly. The animals were examined for signs of toxicity or mortality at least once a day. Detailed clinical examinations in an open field were conducted prior to the start of the administration period and weekly thereafter. Clinicochemical and hematological examinations as well as urinalyses were performed towards the end of the administration period. After the administration period all rats were sacrificed and assessed by gross pathology, followed by histopathological examinations. The following test substance-related, relevant findings were noted: No treatment-related, adverse findings were observed in test group 3: 15000 ppm (1306 mg/kg bw/d in males and 1351 mg/kg bw/d in females. Minimal proximal tubular cell hypertrophy in the kidney of in 4 of 5 male animals accompanied by increased organ weight
(120% absolute and 118% relative). No treatment-related, adverse findings were observed in test group 2: 5000 ppm (415 mg/kg bw/d in males and 456 mg/kg bw/d in females). No treatment-related, adverse findings were observed in test group 1: 1500 ppm (125 mg/kg bw/d in males and 127 mg/kg bw/d in females.The oral administration of test item via diet over a period of 4 weeks revealed pathological findings in male Wistar rats at a concentration of 15000 ppm. Therefore, under the conditions of the present study the no observed adverse effect level (NOAEL) was 415 mg/kg bw/d (5000 ppm) in male and 1351 mg/kg bw/d (15000 ppm) in female Wistar rats.
Dipropylheptylcarbonate (was administered via the diet to groups of 10 male and 10 female Wistar rats over a period 3 months. For the first 2 weeks concentrations in the diet of 0 (vehicle control; test group 0), 1500 (test group 1), 5000 (test group 2) and 15000 ppm (test group 3) were prepared and administered to the animals. After the first 2 weeks until the end of the study period the concentrations in the diet were adjusted to obtain target dose levels of 0 (vehicle control; test group 0), 100 (test group 1), 300 (test group 2) and 1000 mg/kg body weight/day (test group 3).
Food consumption and body weights were determined weekly. The animals were examined for signs of toxicity or mortality at least once a day. Moreover, detailed clinical examinations in an open field were conducted prior to the start of the administration period and weekly thereafter. Ophthalmological examinations were performed before the beginning and at the end of the administration period. For at least 3 weeks an estrous cycle determination was performed. Beside this, a functional observational battery (FOB) as well as measurement of motor activity (MA) were carried out at the end of the administration period. Clinicochemical and hematological examinations as well as urinalyses were performed
towards the end of the administration period. After the administration period all animals were sacrificed and assessed by gross pathology, followed by histopathological examinations.
The following test substance-related, adverse findings were noted:
Test group 3: target dose of 1000 mg/kg bw/d
(achieved doses: about 1141 mg/kg bw/d in males; about 1166 mg/kg bw/d in females)
Clinical Examinations
• No treatment-related, adverse findings were observed.
Clinical Pathology
• Decreased total protein and globulin levels in males
• Decreased sodium and increased potassium levels in males
Pathology
• No treatment-related, adverse findings were observed.
Test group 2: target dose of 300 mg/kg bw/d
(achieved doses: about 356 mg/kg bw/d in males; about 355 mg/kg bw/d in females)
Clinical Examinations, Clinical Pathology and Pathology
• No treatment-related, adverse findings were observed.
Test group 1: target dose of 100 mg/kg bw/d
(achieved dose about 114 mg/kg bw/d in males; about 115 mg/kg bw/d in females)
Clinical Examinations, Clinical Pathology and Pathology
• No treatment-related, adverse findings were observed.
In conclusion, the oral administration of Dipropylheptylcarbonate (Cetiol P5) via diet over a period of 3 months revealed findings with regard to clinical pathology in male Wistar rats at a target dose level of 1000 mg/kg bw/d (achieved dose about 1141 mg/kg bw/d). Therefore, under the conditions of the present study the no observed adverse effect level (NOAEL) was 356 mg/kg bw/d in male and 1166 mg/kg bw/d in female Wistar rats.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
one key study
Justification for classification or non-classification
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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