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EC number: 816-285-7 | CAS number: 1263133-33-0
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.3700 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.31 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: MAFF Japan Test Guidelines for Agricultural Chemicals 12-Nousan-8147 (2000)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Reference substance 002
- Cas Number:
- 1263133-33-0
- Test material form:
- solid
- Details on test material:
- Purity: 99.4%
Impurities: Not reported
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD(SD)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% methylcellulose with 0.1% Tween 80
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- GD 6-20
- Frequency of treatment:
- Once daily
- Duration of test:
- 15 days
Doses / concentrationsopen allclose all
- Dose / conc.:
- 25 mg/kg bw/day (nominal)
- Dose / conc.:
- 50 mg/kg bw/day (nominal)
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Dose / conc.:
- 200 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 20 females/dose
- Control animals:
- yes, concurrent vehicle
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- effects observed, non-treatment-related
- Mortality:
- mortality observed, non-treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Mean maternal body weights were statistically significantly reduced (4-5%) at 200 mg/kg/day from gestation days 18 through 21, compared to the control group. Overall body weight gains were 15% lower (statistically significant) than control group means and corresponded to reduced weight gains observed during the treatment period. These reductions were most pronounced during the first two days of dosing when the reduction was 77% lower than control group. At this same level, adjusted (minus products of conception) final body weight and overall body weight gains were 3% (not statistically significant) and 27% lower (statistically significant) than control group, respectively.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- At 200 mg/kg/day, mean maternal food consumption was lower than control group during treatment resulting in an 11% overall (days 6-21G) reduction (statistically significant) in food consumption compared to the control group.
- Gross pathological findings:
- effects observed, non-treatment-related
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- no effects observed
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day (nominal)
- Basis for effect level:
- body weight and weight gain
- food consumption and compound intake
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): no effects observed - Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- no effects observed
- External malformations:
- effects observed, non-treatment-related
- Skeletal malformations:
- effects observed, treatment-related
- Description (incidence and severity):
- There was a statistically significant increased incidence of short (primarily 13th) ribs at 100 and 200 mg/kg/day. The increased incidence of short ribs was not considered adverse since there was no correlative vertebral findings (i.e vertebral ossification delays) observed at this level and delays in ossification of the 13th rib are expected to resolve postnatally.
- Visceral malformations:
- effects observed, non-treatment-related
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- Developmental toxicity
- Effect level:
- > 200 mg/kg bw/day (nominal)
- Sex:
- male/female
- Remarks on result:
- other: Highest concentration tested
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- NOAEL (Maternal toxicity): 100 mg/kg bw/d (Body weight and food consumption)
NOAEL (Developmental toxicity): >200 mg/kg bw/d (Highest concentration tested) - Executive summary:
The study was conducted according to guidelines, U.S. EPA OPPTS 870.3700 and OECD 414 to evaluate the potential maternal and developmental toxicity of the test substance in pregnant rats. Formulations of the test substance in 0.5% methylcellulose with Tween 80 were administered to presumed pregnant rats once daily by gavage on gestation days (GD) 6-20. The day of mating was defined as gestation day 0.
The dose levels used in the current study were 0, 25, 50, 100, and 200 mg/kg/day; control group animals were administered the vehicle. The dose volume was 10 mL/kg for all groups. Samples of the dosing formulations were collected and analyzed near the beginning and end of the dosing period. The results of these analyses confirmed that the formulations were at targeted concentrations, uniformly mixed, and stable under the experimental conditions used during the study.
During the in-life portion of the study, body weights, food consumption, and clinical observations before and after dosing were collected on a daily basis. All dams were euthanized on GD 21 and the gross necropsy included an examination and description of uterine contents including counts of corpora lutea, implantation sites, resorptions, and live and dead fetuses. All live fetuses were examined externally and euthanized; following euthanasia, fresh visceral and head examinations were performed on selected fetuses. The fetal carcasses were then processed and examined for skeletal alterations.
Under the conditions of this study, maternal toxicity was observed at 200 mg/kg/day as evidenced by treatment-related adverse effects on body weight and food consumption parameters when compared with current control group values. There was no early mortality or adverse treatment-related clinical signs of toxicity at any level tested. Additionally, there were no gross pathological findings associated with treatment on this study. Intrauterine growth and survival were unaffected by maternal treatment. There were no treatment-related increases in external, visceral, or skeletal malformations. Non-adverse, treatment-related fetal findings were limited to an increased incidence of short (primarily 13th) ribs at 100 and 200 mg/kg/day. This fetal anomaly was classified as a developmental variation and was considered non-adverse, as ossification was expected to be completed shortly after birth and was, therefore, not a reflection of developmental toxicity.
Based on the results of this study, the no-observed-adverse-effect level (NOAEL) for maternal toxicity was 100 mg/kg/day based on effects on body weight and food consumption parameters at 200 mg/kg/day. The NOAEL for developmental toxicity was considered to be greater than 200 mg/kg/day.
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