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EC number: 203-721-0 | CAS number: 109-94-4
- 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
Key value for chemical safety assessment
- Toxic effect type:
- concentration-driven
Effects on fertility
Description of key information
Toxicity to reproduction
Based on the experimental studies on test hemical ,No Observed Effect Level (NOEL) was considered to be 1000mg/kg/day in rats for reproductive toxicity as no effects on reproductive organ was observed .Thus, comparing this value with the criteria of CLP regulation test chemical cannot be classified as reproductive toxicant.
Link to relevant study records
- Endpoint:
- reproductive toxicity, other
- Remarks:
- chronic toxicity study
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data from peer reviewed journal
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: As mention below
- Principles of method if other than guideline:
- Reproductive toxicity study of test material was performed on Osborne-Mendel rats.
- GLP compliance:
- not specified
- Limit test:
- yes
- Justification for study design:
- No data available
- Species:
- rat
- Strain:
- Osborne-Mendel
- Details on species / strain selection:
- No data available
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Housing:The animals were housed individually in wire cages
- Use of restrainers for preventing ingestion (if dermal): yes/no
- Diet (e.g. ad libitum):ad libitum
- Water (e.g. ad libitum):ad libitum - Route of administration:
- oral: feed
- Vehicle:
- other: feed
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: The test chemical was mixed with feed at dose level of 0, 1000, 2500 or 10000 ppm (0, 100, 250 or 1000 mg/Kg/day).
DIET PREPARATION
- Rate of preparation of diet (frequency): Weekly
- Mixing appropriate amounts with (Type of food): Details not specified
- Storage temperature of food: No data available
VEHICLE
- Justification for use and choice of vehicle (if other than water): Food
- Concentration in vehicle: 0, 5000, 10000 or 20000 ppm (0, 250, 500 or 1000 mg/Kg/day)
- Amount of vehicle (if gavage): No data available
- Lot/batch no. (if required): No data available
- Purity: No data available - Details on mating procedure:
- No data available
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 17 weeks
- Frequency of treatment:
- Daily
- Details on study schedule:
- No data available
- Remarks:
- 0, 1000, 2500 or 10000 ppm (0, 100, 250 or 1000 mg/Kg bw)
- No. of animals per sex per dose:
- Total: 80
0 mg/kg bw: 10 males and 10 females
100 mg/kg bw: 10 males and 10 females
250 mg/kg bw: 10 males and 10 females
1000 mg/kg bw: 10 males and 10 females - Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data available
- Positive control:
- No data available
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Weekly
- Cage side observations checked in table [No.?] were included. General condition
DETAILED CLINICAL OBSERVATIONS: No data
- Time schedule: No data
BODY WEIGHT: Yes
- Time schedule for examinations: Weekly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes, weekly
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
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
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
- Time schedule for examinations: - Oestrous cyclicity (parental animals):
- No data available
- Sperm parameters (parental animals):
- No data available
- Litter observations:
- No data available
- Postmortem examinations (parental animals):
- GROSS PATHOLOGY: Yes, The tissues of all the rats were examined macroscopically at the time of sacrifice. The viscera were removed and the liver, kidneys, spleen, heart, and testes were weighed.
- Postmortem examinations (offspring):
- No data available
- Statistics:
- No data available
- Reproductive indices:
- No data available
- Offspring viability indices:
- No data available
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- Hematologic findings were normal.
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- not specified
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
- body weight and weight gain
- organ weights and organ / body weight ratios
- gross pathology
- histopathology: non-neoplastic
- Remarks on result:
- other: No effects on reproductive organ
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- not specified
- Behaviour (functional findings):
- not specified
- Developmental immunotoxicity:
- not specified
- Dose descriptor:
- other: not specified
- Generation:
- other: not specified
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: not specified
- Remarks on result:
- not measured/tested
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Description (incidence and severity):
- The animals were housed individually in wire cages
- Reproductive effects observed:
- not specified
- Treatment related:
- not specified
- Conclusions:
- The no observed Adverse Effect Level (NOAEL) for the test chemical using Osborne-Mendel rats for a duration of 17 weeks was considered to be 1000 mg/Kg bw.
- Executive summary:
Reproductive /chronic oral toxicity study of test chemical was performed on male and female Osborne-Mendel rats.10 male and 10female were used in each dose group.The test material was fed through the diet at a concentration of 0, 1000, 2500 or 10000 ppm (0, 100, 250 or 1000 mg/Kg/day)for 17 weeks.Animals were checked for clinical signs, Food consumption and body weight every week. At the termination of the experiments the rats were sacrificed and exsanguinated.The tissues of all the rats were examined macroscopically at the time of sacrifice. The viscera were removed and the liver, kidneys, spleen, heart, and testes were weighed. These organs, the remaining abdominal and thoracic viscera, and one hind leg, for bone, bone marrow, and muscle, were preserved in 10% buffered formalin-saline solution for histopathological examination. For routine histopathology, sections were embedded in paraffin wax and stained with haematoxylin and eosin.No treatment-related clinical signs and premature deaths were observed. No relevant necropsy findings were noted. No effects on testes weight was noted in treated rats at dose concentration 1000mg/kg bw, Based on the observations made, the no observed Adverse Effect Level (NOAEL) for the test chemical using Osborne-Mendel rats for a duration of 17 weeks is considered to be 1000 mg/Kg bw
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- Data is from peer reviewed journal
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Reproductive toxicity
The study on test chemical has been investigated for reproductive toxicity .The study is as mentioned below:
Reproductive /chronic oral toxicity study of test chemical was performed on male and female Osborne-Mendel rats.10 male and 10female were used in each dose group.The test material was fed through the diet at a concentration of 0, 1000, 2500 or 10000 ppm (0, 100, 250 or 1000 mg/Kg/day)for 17 weeks.Animals were checked for clinical signs, Food consumption and body weight every week. At the termination of the experiments the rats were sacrificed and exsanguinated.The tissues of all the rats were examined macroscopically at the time of sacrifice. The viscera were removed and the liver, kidneys, spleen, heart, and testes were weighed. These organs, the remaining abdominal and thoracic viscera, and one hind leg, for bone, bone marrow, and muscle, were preserved in 10% buffered formalin-saline solution for histopathological examination. For routine histopathology, sections were embedded in paraffin wax and stained with haematoxylin and eosin.No treatment-related clinical signs and premature deaths were observed. No relevant necropsy findings were noted. No effects on testes weight was noted in treated rats at dose concentration 1000mg/kg bw, Based on the observations made, the no observed Adverse Effect Level (NOAEL) for the Ethyl formate using Osborne-Mendel rats for a duration of 17 weeks is considered to be 1000 mg/Kg bw
Thus, based on the above experimental studies of test chemical , No Observed Effect Level (NOEL) was considered to be 1000mg/kg/day in rats for reproductive toxicity .Thus, comparing this value with the criteria of CLP regulation test chemical cannot be classified as reproductive toxicant.
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Toxicity to reproduction: other studies
Description of key information
No compound related effects were observed, the no observed adverse effect level ( NOAEL) value for teretogenicity of test chemical was considered to be 25 mg/egg in chicken embryo.
Link to relevant study records
- Endpoint:
- toxicity to reproduction: other studies
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data from peer reviewed journal
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- Teratogenicity of test Chemicals was performed in the Developing Chicken Embryo
- GLP compliance:
- not specified
- Type of method:
- in vitro
- Species:
- other: Chicken
- Strain:
- other: Single-Comb White Leghorn
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No data avilable
- Route of administration:
- other: Injection (Via Yolk and via air cell injection)
- Vehicle:
- not specified
- Details on exposure:
- No data avilable
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- At two stages of incubation: preincubation (0 hr) and at the fourth day (96 hr)
- Frequency of treatment:
- At 0h and 96 h
- Duration of test:
- 96 h
- Remarks:
- 0.50 to 75 mg/egg (5 dose level)
- No. of animals per sex per dose:
- 500 eggs (100 eggs per dose)
- Control animals:
- yes
- Statistics:
- No data avilable
- Dose descriptor:
- NOAEL
- Effect level:
- 25 other: mg/egg
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: No teratogenic effect were observed
- Remarks on result:
- other: No teratogenic effect were observed
- Conclusions:
- The NOAEL value for teretogenicity of test chemical was considered to be 25 mg/egg in chicken embryo.
- Executive summary:
Teretogenicity study of test chemical was conducted in Fresh fertile eggs from Single-Comb White LeghornChicken.Test chemical was administered by two routes, into tha yolk and through the air cell. For each enjection route, eggs were treated at0h and at 96 h. Five dose level tested range from 0.50 to 75 mg/egg and 100 embryos were treated per dose. Mortality, abnormalities included
all structural anomalies as well as toxic responses such as edema, hemorrhage, hypopigmentation of the down, significant growth retardation, cachexia, and other nerve disorders.Structural abnormality of the head, viscera, limbs, or body skeleton were examined. No teretogenic effect observed at dose level of 25 mg/egg. Hence,the NOAEL value for teretogenicity of test chemical was considered to be 25 mg/egg in chicken embryo.
Reference
Additional information
Teretogenicity study of test chemical was conducted in Fresh fertile eggs fromSingle-Comb White LeghornChicken. Test chemical was administered by two routes, into tha yolk and through the air cell. For each enjection route, eggs were treated at0h and at 96 h. Five dose level tested range from 0.50 to 75 mg/egg and 100 embryos were treated per dose. Mortality, abnormalities included all structural anomalies as well as toxic responses such as edema, hemorrhage, hypopigmentation of the down, significant growth retardation, cachexia, and other nerve disorders.Structural abnormality of the head, viscera, limbs, or body skeleton were examined. No teretogenic effect observed at dose level of 25 mg/egg. Hence,the NOAEL value for teretogenicity of test chemical was considered to be 25 mg/egg in chicken embryo.
Justification for classification or non-classification
Thus, comparing this value with the criteria of CLP regulation test chemical cannot be classified as reproductive toxicant.
Additional information
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.