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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 203-569-5 | CAS number: 108-29-2
- 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
Carcinogenicity
Administrative data
Description of key information
In a chronic carcinogenity study in mice, repeated subcutaneous exposure to approx. 3.4 mg/kg bw of the test item 3 times a week for 4 weeks induced no tumors after 18 months.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- Endpoint:
- carcinogenicity, other
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- Data published in 1970
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- - Principle of test: 18 months carcinogenicity study in mice after subcutaneously injections.
- Short description of test conditions: CFW Swiss-Webster mice (2 month of age) were randomly divided into a group of 16 animals after 1 week of quarantine. They were housed in plastic shoe-box type cages in air conditioned quarters, with heat-treated absorbent cedar cubed wood for bedding. The animals were fed Teklad mouse diet pellets and water ad libitum. Water bottles were treated weekly with a germicidal detergent, and the animals were transferred to clean cages twice a week. 16 mice were subcutaneously injected 2 mg of the test material in 0.1 mL tricaprylin to the inguinal region of the rats. Injections were made to approximately the same site, and repeated 2 –3 times each week, for a total of 10 – 114 injections. The control animals were untreated.
- Parameters analysed / observed: All the animals were weighed at the start of the experiments and at regular intervals throughout the observation period of 18 months. They were observed twice weekly for the appearance of subcutaneous tumors. Animals with tumors or those in poor condition were sacrificed and necropsied. Suspected neoplasms and other grossly abnormal tissues were removed, fixed and histologically examined. - GLP compliance:
- not specified
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source: Givaudan-Delawanna Inc., New York
- Purity: >98 % - Species:
- mouse
- Strain:
- Swiss Webster
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: H. B. Andervont's (BALB/c mice) and Carworth Inc., New York (CFW mice)
- Females nulliparous and non-pregnant: Yes
- Age at study initiation: 2 month
- Housing: In groups of 8, in plastic shoe-box type cages with heat-treated absorbent cedar cubed wood
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not indicated, quarters are air conditioned
- Humidity (%): Not indicated
- Air changes (per hr): Not indicated
- Photoperiod: Not indicated - Route of administration:
- subcutaneous
- Vehicle:
- other: tricaprylin
- Details on exposure:
- VEHICLE
- Concentration in vehicle: 20 mg/mL
- Amount of vehicle: 0.1 mL - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 4 weeks
- Frequency of treatment:
- 3 times/week
- Post exposure period:
- 18 months
- Dose / conc.:
- 34.3 mg/kg bw/day
- Remarks:
- 2 mg in 0.1 mL vehicle was injected 3 times/week. Assuming a mean rat body weight of 250 g, the dose was approx. 8 mg/kg bw and 3.4 mg/kg bw/day.
- No. of animals per sex per dose:
- 16 females per dose
- Control animals:
- yes, concurrent no treatment
- yes, concurrent vehicle
- Positive control:
- Not specified
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations: At the start of the experiment, at regular intervals throughout the ensuing period of observation
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data
OPHTHALMOSCOPIC EXAMINATION: No data
HAEMATOLOGY: No data
CLINICAL CHEMISTRY: No data
URINALYSIS: No data
NEUROBEHAVIOURAL EXAMINATION: No data - Sacrifice and pathology:
- GROSS PATHOLOGY: Not specified (animals with tumors or those in poor condition were killed and autopsied)
HISTOPATHOLOGY: Yes (suspected neoplasms and other grossly abnormal tissues were removed and fixed in buffered 10 % formalin. All diagnoses were based on histological examination of sections stained with hematoxylin and eosin) - Other examinations:
- Not specified
- Statistics:
- Not specified
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- effects observed, non-treatment-related
- Description (incidence and severity):
- In some instances, ulcerations developed at the sites of injection. However, as their number was low, no relation to the administered material could be established.
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- 3/16 mice died after 18 month of treatment which represents the normal mortality for mice of this age and is comparable to the mortality of conroll mice.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No excessive weight losses or gains were found as compared to the untreated control group.
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Endocrine findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- no effects observed
- Description (incidence and severity):
- No subcutaneous sarcomas, pulmonary tumors, breast cancers, lymphomas or other tumors were found after 18 months of observation.
- Other effects:
- not specified
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 3.4 mg/kg bw/day
- Based on:
- test mat.
- Remarks:
- 2 mg in 0.1 mL vehicle was injected 3 times/week. Assuming a mean rat body weight of 250 g, the dose was approx. 3.4 mg/kg bw/day.
- Sex:
- female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Key result
- Critical effects observed:
- no
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Classification, Labeling, 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. As the test substance showed no carcinogenic potential in any study, it is not considered to be classified for carcinogenity under Regulation (EC) No 1272/2008, as amended for fifteenth time in Regulation (EU) No 2020/217.
Additional information
Carcinogenicity, mouse, RL2
CFW Swiss-Webster mice (2 month of age) were randomly divided into a group of 16 animals after 1 week of quarantine. They were housed in plastic shoe-box type cages in air conditioned quarters, with heat-treated absorbent cedar cubed wood for bedding. The animals were fed Teklad mouse diet pellets and water ad libitum. Water bottles were treated weekly with a germicidal detergent, and the animals were transferred to clean cages twice a week. 16 mice were subcutaneously injected 2 mg of the test material in 0.1 mL tricaprylin to the inguinal region of the rats. Injections were made to approximately the same site, and repeated 2 –3 times each week, for a total of 10 – 114 injections. The control animals were untreated. All the animals were weighed at the start of the experiments and at regular intervals throughout the observation period of 18 months. They were observed twice weekly for the appearance of subcutaneous tumors. Animals with tumors or those in poor condition were sacrificed and necropsied. Suspected neoplasms and other grossly abnormal tissues were removed, fixed and histologically examined. After 18 months, 13/16 mice were alive. None of the mice developed subcutaneous sarcomas, pulmonary tumors, breast cancers, lymphomas or other tumor (Swern et al., 1970).
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.