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EC number: 203-311-1 | CAS number: 105-58-8
- 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
Effects on fertility
Link to relevant study records
- Endpoint:
- multi-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1966
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Older study described in sufficient detail, but not all endpoints according to recent standard protocols examined
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- see below
- GLP compliance:
- no
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Weight at study initiation: 145-160 g
Housing: individually caging
Diet: ad libitum
Water: ad libitum
ENVIRONMENTAL CONDITIONS
Temperature (°C): 26-28 - Route of administration:
- oral: drinking water
- Vehicle:
- water
- Details on exposure:
- Drinking water solutions were prepared daily
Concentration in vehicle: 0, 0.015, 0.075 or 0.3 % (w/v) - Details on mating procedure:
- the animals were mated for 20 days with daily changes of partner
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- breeding was done until F3 generation
- Frequency of treatment:
- continuously via drinking water
- Details on study schedule:
- After 9 weeks of treatment, 10 male and 10 female rats dosed with 0 or 0.015 % were mated for 20 days (daily changes of partner). After 27 weeks of treatment, groups of 10 rats dosed with 0.075 and 0.3 % were mated in the same way. For the F1 generation a comparable dosage/treatment regimen was used and at an appropriate age and weight they were used for breeding the F2-generation. The F3-generation was bred from the F2-generation in the same way.
- Remarks:
- Doses / Concentrations:
0, 0.015, 0.075 or 0.3 % (ca. 0, 4, 22 or 90 mg/rat/day)
Basis:
nominal in water - No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
- Positive control:
- no
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS / CLINICAL OBSERVATIONS: Yes (not further specified)
BODY WEIGHT: Yes (not further specified)
HAEMATOLOGY: Yes (blood glucose) - Oestrous cyclicity (parental animals):
- no data
- Sperm parameters (parental animals):
- not examined
- Litter observations:
- PARAMETERS EXAMINED: number of pups, stillbirths, live births, postnatal mortality, presence of gross anomalies, weight gain
GROSS EXAMINATION OF DEAD PUPS: abnormalities - Postmortem examinations (parental animals):
- SACRIFICE: up to 10 m and 10 f from each generation
GROSS NECROPSY: yes
HISTOPATHOLOGY: yes (not described in detail)
ORGAN WEIGHTS: yes (pituitary, thyroid, adrenals, ovaries) - Postmortem examinations (offspring):
- not described in detail
- Statistics:
- no data
- Reproductive indices:
- not described in detail
- Offspring viability indices:
- not described in detail
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Other effects:
- not specified
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- no effects observed
- Dose descriptor:
- NOAEL
- Effect level:
- 90 other: mg/animal/day
- Sex:
- male/female
- Remarks on result:
- other: Generation: P to F3 generation (migrated information)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Sexual maturation:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- no effects observed
- Reproductive effects observed:
- not specified
- Conclusions:
- In a multi-generation study, groups of 10 male and 10 female Wistar rats were dosed with 0 - 0.3 % (up to 90 mg/rat/day) via drinking water. In none of the different generations (P to F3) adverse effects were seen and the dosing had no adverse effects on fertility or on foetal development.
- Executive summary:
In a multi-generation study, groups of 10 male and 10 female Wistar rats were dosed with 0 - 0.3 % (up to 90 mg/rat/day) via drinking water. In none of the different generations (P to F3) adverse effects were seen and the dosing had no adverse effects on fertility or on foetal development.
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- NOAEL: 90 mg/rat/day
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
In a multi-generation study, male and female Wistar rats were dosed with 0 - 0.3 % (up to 90 mg/rat/day) via drinking water. In none of the different generations (P to F3) adverse effects were seen and the dosing had no adverse effects on fertility or on foetal development.
Effects on developmental toxicity
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1969
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Unpublished data cited in a peer-reviewed publication
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- see below
- GLP compliance:
- no
- Limit test:
- no
- Species:
- rat
- Strain:
- other: FB30
- Details on test animals or test system and environmental conditions:
- Age at study initiation: 10-14 weeks
Weight at study initiation: 200-250 g - Route of administration:
- oral: drinking water
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- no
- Details on mating procedure:
- not further specified
- Duration of treatment / exposure:
- days 6-15 of gestation
- Frequency of treatment:
- continuously via drinking water
- Duration of test:
- not further specified
- Remarks:
- Doses / Concentrations:
0.01, 0.1 and 1 % in drinking water (ca. 34, 351 and 3204 mg/rat/day)
Basis: - No. of animals per sex per dose:
- 10 f
- Control animals:
- yes
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: No data
WATER CONSUMPTION AND COMPOUND INTAKE: Yes
POST-MORTEM EXAMINATIONS: Yes - Ovaries and uterine content:
- not further specified
- Fetal examinations:
- not further specified
- Statistics:
- no data
- Indices:
- not further specified
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
- Dose descriptor:
- NOAEL
- Effect level:
- 3 204 other: mg/rat/day
- Basis for effect level:
- other: maternal toxicity
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
- Dose descriptor:
- NOAEL
- Effect level:
- 3 204 other: mg/rat/day
- Basis for effect level:
- other: teratogenicity
- Dose descriptor:
- NOAEL
- Effect level:
- 3 204 other: mg/rat/day
- Basis for effect level:
- other: embryotoxicity
- Abnormalities:
- not specified
- Developmental effects observed:
- not specified
- Conclusions:
- In this study with female FB30 rats, the dosing with up to 3204 mg/rat/day via drinking water from day 6-15 of gestation caused no maternal toxicity or embryotoxic and teratogenic effects.
- Executive summary:
In this study with female FB30 rats, the dosing with up to 3204 mg/rat/day via drinking water from day 6-15 of gestation caused no maternal toxicity or embryotoxic and teratogenic effects.
Reference
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- NOAEL: 3204 mg/rat/day
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
In a study with female rats, the dosing with up to 3204 mg/rat/day via drinking water from day 6-15 of gestation caused no maternal toxicity or embryotoxic and teratogenic effects.
Justification for classification or non-classification
Based on the negative results obtained, no classification according to EU and GHS criteria is required.
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.
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