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EC number: 221-220-5 | CAS number: 3033-62-3
- 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
Description of key information
A key, reliable prenatal development study (K2, equivalent to OECD guideline 414; BRRC, 1985) is available. Therefore, no screening reproduction/developmental toxicity study is performed, according to the REACH Regulation column 2, annex IX, section 8.7.2.
A test proposal for an extended one-generation reproductive toxicity study is included in the dossier. This study will be performed according to OECD guideline 443, with a basic study design (rat, oral gavage, no additional cohorts).
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no adverse effect observed
Additional information
Data from repeated dose toxicity studies
No significant effects on reproductive organs were observed in a 90 -day (13 week) repeated dose dermal study nor in a 14 -week vapor inhalation study. In addition no data indicating developmental toxicity at doses that did not cause maternal toxicity were reported in a pre-natal development toxicity study as described below.
In the 90-day dermal repeated dose study, conducted using protocols equivalent to OECD Guideline 411 (Subchronic Dermal Toxicity: 90-Day Study) NZW rabbits were dosed with 0%, 0.2%, 0.7% or 2% [equivalent to 0, 0.74, 2.8 or 8 mg/kg bw/day, respectively] for 6 hrs/day, 5 days/wk for 13 weeks (90 days). No treatment-related effects were seen in any reproductive organs in either males or females at any dose level. Some signs of irritation were observed at the site of contact but no systemic toxicity was reported. The NOAEL was >=8 mg/kg bw/day.
In a vapor inhalation study, Sprague-Dawley rats were exposed to 0, 0.23, 1.25, or 5.8 ppm [0, 1.51, 8.2, or 38.0 mg/m3, respectively] via whole body exposure for 6 hours/day, 5 days/week for 14 weeks. No significant treatment-related effects were seen in any reproductive organs in either males or females at any dose level. Exposure-related increases in relative organ weights were observed for the adrenals and testes of males from the 38.0 mg/m3 group at the 14-week time point, but not after the 6-week recovery period and these organs showed no histologic abnormalities. The NOAEL was 8.2 mg/m3 based on non-systemic toxicity observed at 38.0 mg/m3. Local toxicity was reported at 1.51 mg/m3 including eye and respiratory tract irritation.
Prenatal developmental toxicity study
In addition to
the repeated dose studies described above, a
dermal Prenatal Developmental Toxicity Study was
carried out in NZW rabbits conducted using protocols equivalent to OECD
Guideline 414. Rabbits were exposed to 0, 1, 5 and 10 % [ca 2.4, 12 and
24 mg/kg bw/day], resepectively for 6 hrs per day on gestatation day
6-18. Histopathological changes in the kidney with vacuolar swelling of
the collecting ducts were reported at 12 and 24 mg/kg bw/day in maternal
animals and a significant decrease in body weight gain occurred at 24
mg/kg bw/day. The NOAEL for maternal toxicity was >= 2.4 - 12 mg/kg
bw/day. In the foetus, a significant decrease in mean litter weight and
female fetal body weight per litter was observed at 24 mg/kg bw/day.
Male fetal body weights were also decreased although did not reach
statistical significance. The NOAEl for fetotoxicity was >= 12 - 24 mg/kg
bw/day. In terms of teratogenicity, no treatment-related effects on
number of ovarian corpora lutea of pregnancy, total implantations,
viable or non-viable implantations per litter, percent pre-implantation
loss, percent live fetuses per litter, or on sex ratio (% males) were
observed at any dose group studied. The NOAEL for embryotoxicity was
>=24 mg/kg bw/day. These
data suggest that any fetal effects that occur do so at doses that also
cause maternal toxicity hence may not be a direct chemical effect.
Results from the pre-natal development toxicity study indicated no
treatment-related effects on number of ovarian corpora lutea of
pregnancy, total implantations, viable or non-viable implantations per
litter, percent pre-implantation loss, percent live fetuses per litter,
or on sex ratio (% males). In addition, no significant treatment-related
effects on reproductive organs in males or females were observed in a
14-week vapor inhalation study in rats or in a 90-day dermal study in
rabbits.
Extended one-generation reproductive toxicity study
A test proposal for an extended one-generation reproductive toxicity study is included in the dossier. This study will be performed according to OECD guideline 443, with a basic study design (rat, oral gavage, no additional cohorts).
Effects on developmental toxicity
Description of key information
A key, reliable prenatal development study (K2, equivalent to OECD guideline 414; BRRC, 1985) is available. Therefore, no screening reproduction/developmental toxicity study is performed, accordign to the REACH Regulation column 2, Annex IX, section 8.7.2.
Administration of the test substance by dermal application to timed-pregnant New Zealand white rabbits during organogenesis (gestation days 6 -18) resulted in maternal toxicity at 10% and 5%, i.e., transient reduced weight gain during exposure at 10%, renal lesions at 5 and 10% and elevated kidney weight at 10%. There was no maternal toxicity at 1% except for transient irritation at the application site. Toxicity to the fetus (reduced fetal body weight per litter) was observed unaccompanied by any indication of reduced fetal ossification, only at 10%, a dose which also produced signs of maternal toxicity. There was no evidence for embryotoxicity or teratogenicity at any dose level employed.
A test proposal for a prenatal developmental toxicity study in a second species (the rat) is included to the dossier. This study will be performed according to OECD guideline 414.
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:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 12 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rabbit
- Quality of whole database:
- A single non GLP study is available following a protocol that is equivalent to OECD Guidelines (excepting that animals were only treated from gestation days 6-18). The study was well documented, sufficient number of animals and doses were employed, and a vehicle and untreated control group were included.
Additional information
A well documented study following a protocol equivalent to OECD Guideline 414 is available. Administration of the test item by dermal application to timed-pregnant New Zealand white rabbits during organogenesis (gestation days 6-18) resulted in maternal toxicity at 10% (ca. 24 mg/kg bw) and 5% (ca. 12 mg/kg bw), i.e., transient reduced weight gain during exposure at 10%, renal lesions at 5 and 10% and elevated relative kidney weight at 10%. There was no maternal toxicity at 1% (ca. 2.4 mg/kg bw) except for transient irritation at the application site. Toxicity to the fetus (reduced fetal body weight per litter) was observed unaccompanied by any indication of reduced fetal ossification, only at 10%, a dose which also produced signs of maternal toxicity. There was no evidence for embryotoxicity or teratogenicity at any dose level employed.
A test proposal for a prenatal developmental toxicity study in a second species (the rat) is included in the dossier. The study will be performed according to OECD guideline 414.
Justification for classification or non-classification
Based on the results, the test subtance does not meet the criteria for classification as reproductive or developmental toxicant according to CLP Regulation 1272/2008.
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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