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EC number: 635-156-4 | CAS number: 109293-98-3
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 1994-02-09 to 1994-09-30
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted under the regulations of GLP and the respective guideline. A read-across approach was used. For justification please refer to IUCLID Section 13.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: U.S. Environmental Protection Agency Pesticide Assessment Guidelines Subdivision F, 83-3
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- treatment from GD 6 to GD 15
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.31 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- treatment from GD 6 to GD 15
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 109293-97-2
- EC Number:
- 600-910-3
- Cas Number:
- 109293-97-2
- IUPAC Name:
- 109293-97-2
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: HRP, Inc., Denver, Pennsylvania
- Age at study initiation: 11 month
- Weight at study initiation: 2.8 to 5 kg
- Fasting period before study: no
- Housing: individual
- Diet: Certified Rabbit Diet #5322, ad libitum
- Water: R.O. water incl. chlorine, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 61-72
- Humidity (%): 40-60
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Aqueous 0.5% methylcellulose
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Suspensions of the test substance were prepared daily
VEHICLE
- Justification for use and choice of vehicle: common vehicle
- Concentration in vehicle: 3, 10 and 30 mg/mL
- Amount of vehicle: 10 mL/kg
- Lot/batch no.: 922148 - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Method: HPLC-UV
Column: Supelcosil LC-18, 5µm 15 cm x 4.6 mm or equivalent
Mobile phase: ACN / 0.05 M trifluoroacetic acid in water (1/1, v/v)
Detector Wavelength: 280 nm
Injection Volume: 5 µL
Flow rate: 0.6 mL/min
Results of analyses of suspensions of the test substance demonstrated that homogeneous suspensions could be achieved for the range of dosages administered for this study. Concentrations prepared for the first and last day of dosage for this study averaged within +/- 10 % of the target value. - Details on mating procedure:
- Timed-pregnant female rabbits were used.
- Duration of treatment / exposure:
- GD 6 to GD 19
- Frequency of treatment:
- Once a day
- Duration of test:
- 24 days (up to GD 29)
Doses / concentrations
- Remarks:
- Doses / Concentrations:
30,100, 300 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 20 females/dose
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Dosages were selected on the basis of two dosage-range studies
- Rationale for animal assignment: random
- Route of administration rationale: The oral route (via gavage) was selected for use because- 1) in comparison with the dietary route, the exact dosage can be accurately administered and 2) it is one possible route of human exposure.
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice each day
- Cage side observations: viability.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: immediately before and one hour after dosage from GD6 to GD19 and once from GD20 to GD29
BODY WEIGHT: Yes
- Time schedule for examinations: daily during dosage period and on GD20, GD24 and GD29
FOOD CONSUMPTION: Yes
- Time schedule for examinations: daily during dosage and post-dosage period
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 29
- Organs examined: tissues with gross lesions - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes
- Head examinations: Yes - Fetal examinations:
- - External examinations: Yes, all per litter
- Soft tissue examinations: Yes, all per litter
- Skeletal examinations: Yes, all per litter - Statistics:
- I. Parametric:
Bartlett's Test - Analysis of Variance - Dunnet's Test
II: Nonparametric:
A: Kruskal-Wallis Test (<75% ties) - Dunn's Test
B: Fisher's Exact Test
III. Test for Proportion Data:
Variance Test for Homogeneity of the Binomial Distribution - Indices:
- no data
- Historical control data:
- Historical control data from 105 studies are available.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Details on maternal toxic effects:
The increase mortality and abortion incidences in Group IV were considered effects of the 300 mg/kg bw/day dosage of the test substance because these does generally had abnormal feces, persistent weight loss and reduced feed consumption from the beginning of the dosage period. Necropsy of five of these Group IV does that died or aborted revealed a gastric trichobezoar, an observation probably associated with altered gastric motality and emtying as the result of the high viscosity of the test substance suspension; a gastric trichobezoar also occurred in one Group IV doe that survived to scheduled sacrifice.
All other deaths and abortions were considered unrelated to the test substance because they were sequelae of intubation accidents, there were no observations indicative of effects of the test substance and the incidences were not dosage-dependent.
One death in each Group I, II, III and IV appeared to be sequelae of an intubation accident. One Group II doe that died did not have adverse clinical or necropsy observations or remarkable weight losses or reductions in feed consumption.
The premature delivery of a litter by one Group I doe on GD 29 was a spontaneous event unrelated to the vehicle.
One doe died on GD 28 during abortion of a litter of four late resorptions. Necropsy of the doe revealed a gastric trichobezoar interrelated with clinical observations, no weight gain and essentially absent feed consumption on GD 8 to 27.
One doe was found dead in GD 13. The litter consisted of nine embryos and two early resorptions. Although no adverse clinical or necropsy observation occurred in this doe, other characteristic effects of the test substance, weight loss and reduced feed consumption an GD 6 to 12 were present.
One doe was found dead on GD 28. The litter sonsisted of 11 apparently normal fetuses. Necropsy of the doe revealed a gestric trichobezoar interrelated with abnormal feaces, persistent weight loss after GD 13 and reduced feed consumption on GD 6 to 27.
Abnormal feces were characteristic effects of the test substance in Groups III and IV. Increased numbers of Group III and IV dies had soft or liquid feces or dried feces; significant (p<0.01) numbers of Group IV does had absent feces or mocoid feces.
All other clinical observations were considered unrelated to the test substance.
Significant numbers (p< 0.01) of Group IV does had a gastric trichobezoar, an observation presumed to be related to effects on feed consumption and gastric motility associated with the thick consistency of the high dosage suspension. All does that had a gastric trichobezoar, regardless of dosage group, had an interval of severly reduced feed consumption.
Group III and IV lost weight for the entire dosage period (GD 6 to 20). Average maternal body weights were comparable among the four doseage groups throughout the study.
Group IV absolute and relative feed consumption values for the entire dosage period (GD 6 to 20) were reduced to 78.8% and 76.5% of the Group I values, respectively. The severity of these effects tended to increase during the dosage period.
After completion of the dosage period, absolute feed consumption values tended to increase in all groups given the test substance (rel. feed consumption values were unaffected), observations interrelated with the weight gains that also occurred in these groups after completion of the dosage period.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 30 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Details on embryotoxic / teratogenic effects:
Pregnancy occurred in 19, 16, 19 and 17 of the 20 naturally bred does in Group I through Group IV, respectively. 17, 15, 17 and 9 pregnant does in Groups I to IV, erspectively, were Caesarean-sectioned on GD 29. Caesarean-sectioning and litter parameters were unaffected by the test substance. The litter average for corpora lutea, implantations, litter sizes, live and dead fetuses, early and late resoptions, fetal body weight, percent male fetuses and percent dead or resorbed conceptuses were comparable among the four dosage groups.
Totals of 130, 111, 105 and 63 live, GD29 Caesarean-delivered fetuses in Group I through Group IV, respectively, were examined for gross external, soft tissue and skeletal alterations and average numbers of fetal ossification.
Combination of malformations and variations resulted in the following incidences for fetal alterations. In Groups I through IV, respectively, 14 (82.4%), 13 (92.8%), 12 (70.6%) and 8 (88.9%) litters had fetuses with any alterations observed. In these same respective dosage groups, the total numbers of fetuses with identified alterations were 45 (34.6%), 29 (26.1%) , 29 (27.6%) and 15 (23.8%).
Group IV had significant increases (P≤0.01) in the incidence of supernumerary thoracic ribs. This reversible fetal alteration is common at maternally toxic dosages, was evident as significant increases (P≤0.01) in the average numbers of pairs of ribs per fetus and related significant changes (P≤0.05) in the average numbers of thoracic and lumbar vertebrae (increases and decreases, respectively).
No other gross external, soft tissue or skeletal malformations or variations in the fetuses were considered effects of the test substance because: 1) the observations are frequent inthis strain of rabbit; 2) the incidences were within the ranges observed historically and/or 3) in the incidences were not dosage-dependent.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
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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