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Diss Factsheets
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EC number: 205-447-7 | CAS number: 141-01-5
- 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:
- dose-dependent
Effects on fertility
Description of key information
A pre-natal developmental toxicity study was performed to evaluate the possibility of placental transfer of the test chemical in rats. An oral trial in rats dosed with 2.0 to 200 mg/kg of the test chemical from the 6th to 15th day of gestation. The dosed rats were observed for pre-natal, post-natal and placental transfer of the test chemical. The test chemical did not result in embryotoxic or fetal effects or congenital malformations. Hence, the NOAEL value can be considered to be 200 mg/kg
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data is from authoritative database
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- A pre-natal developmental toxicity study was performed to evaluate the possibility of placental transfer of the test chemical in rats
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- no data available
- Route of administration:
- oral: unspecified
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- not specified
- Details on exposure:
- no data available
- Details on mating procedure:
- no data available
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- day 6 to day 15 of gestation
- Frequency of treatment:
- daily
- Details on study schedule:
- no data availabler
- Remarks:
- 2-200 mg/kg
- No. of animals per sex per dose:
- no data available
- Control animals:
- not specified
- Details on study design:
- no data available
- Mortality:
- 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
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- no effects observed
- Description (incidence and severity):
- did not result in embryotoxic or fetal effects or congenital malformations.
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- The test chemical did not result in embryotoxic or fetal effects or congenital malformations.
- Dose descriptor:
- NOAEL
- Effect level:
- 200 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: The test chemical did not result in embryotoxic or fetal effects or congenital malformations.
- Critical effects observed:
- no
- 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
- Anogenital distance (AGD):
- not specified
- Nipple retention in male pups:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- no effects observed
- Description (incidence and severity):
- The test chemical did not result in embryotoxic or fetal effects or congenital malformations.
- Behaviour (functional findings):
- not specified
- Developmental immunotoxicity:
- not specified
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 200 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: The test chemical did not result in embryotoxic or fetal effects or congenital malformations.
- Critical effects observed:
- no
- Reproductive effects observed:
- no
- Conclusions:
- The test chemical did not result in embryotoxic or fetal effects or congenital malformations. Hence, the NOAEL value can be considered to be 200 mg/kg
- Executive summary:
A pre-natal developmental toxicity study was performed to evaluate the possibility of placental transfer of the test chemical in rats. An oral trial in rats dosed with 2.0 to 200 mg/kg of the test chemical from the 6th to 15th day of gestation. The dosed rats were observed for pre-natal, post-natal and placental transfer of the test chemical. The test chemical did not result in embryotoxic or fetal effects or congenital malformations. Hence, the NOAEL value can be considered to be 200 mg/kg
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 200 mg/kg bw/day
- Study duration:
- subacute
- Experimental exposure time per week (hours/week):
- 168
- Species:
- rat
- Quality of whole database:
- Klimisch Rating 2
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Various studies have been reviewed to evaluate the reproductive toxicity potential of the test chemical. The results are mentioned below:
A pre-natal developmental toxicity study was performed to evaluate the possibility of placental transfer of the test chemical in rats. An oral trial in rats dosed with 2.0 to 200 mg/kg of the test chemical from the 6th to 15th day of gestation. The dosed rats were observed for pre-natal, post-natal and placental transfer of the test chemical. The test chemical did not result in embryotoxic or fetal effects or congenital malformations. Hence, the NOAEL value can be considered to be 200 mg/kg
This is supported by a similar pre-natal developmental toxicity study performed to evaluate the possibility of placental transfer of the test chemical in mice. An oral trial in mice dosed with 1.6 to 160 mg/kg of the test chemical from the 6th to 15th day of gestation. The dosed rats were observed for pre-natal, post-natal and placental transfer of the test chemical. The test chemical did not result in embryotoxic or fetal effects or congenital malformations. Hence, the NOAEL value can be considered to be 160 mg/kg
These results are further strengthened by study performed on guinea pigs to report whether exposure to the test chemical caused effect on reproduction and lactation. Groups of 12 male and female guinea pigs were dosed with 1% test chemical in diet (i.e approx 400 mg/kg/day). The exposure period was not reported.There were no detectable toxic effects on growth, reproduction or lactation of the test chemical treated guinea pigs. Hence, the NOAEL value can be considered to be 400 mg/kg/day.
Based on the available information, the test chemical can be regarded as safe during maternity and lactation. The NOAEL value can be considered to be 200 mg/kg/day.
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available information, the test chemical can be regarded as safe during maternity and lactation.
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.