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Diss Factsheets
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EC number: 476-900-6 | CAS number: -
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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:
- key study
- Study period:
- 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented, according to accepted guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.3700 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- MPI Research 54943 North Main Street Mattawan, Ml 49071-9399 U.S.A.
- Limit test:
- no
Test material
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Portage, Michigan
- Age at study initiation: 8 weeks
- Weight at study initiation: 170 to 223 g
- Fasting period before study: None
- Housing: Animals were individually housed in suspended, stainless steel, wire-mesh cages
- Diet (e.g. ad libitum): Certified Rodent Chow #5002, PMI Feeds, Inc., St. Louis, Missouri; available ad libitum
- Water (e.g. ad libitum): Tap water; available ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 68 to 72°F (20 to 22.2°C)
- Humidity (%): 48 to 71%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on exposure:
- The test article was added to the vehicle to achieve the required concentrations, and mixed using a magnetic stir bar. The prepared test article solutions were transferred to amber glass containers by syringe and stored under refrigerated conditions.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The test article was characterized using a combination of HPLC and 1H and 13C NMR
- Details on mating procedure:
- - Impregnation procedure: [purchased timed pregnant] Females were time mated upon delivery, and the day on which evidence of copulation was observed was designated gestational day 0
- Proof of pregnancy: Not reported - Duration of treatment / exposure:
- From gestational day 6 to 19
- Frequency of treatment:
- Once/day
- Duration of test:
- day 6 of gestation until day 20 of gestation
Doses / concentrations
- Remarks:
- Doses / Concentrations:
100, 400, and 1000 mg/kg bw
Basis:
actual ingested
- No. of animals per sex per dose:
- 30 females/group
- Control animals:
- yes, concurrent vehicle
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: At least twice per day during the study period
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Once daily from gestational day 6 through 20
BODY WEIGHT: Yes
- Time schedule for examinations: Body weights recorded on gestational days 0, 6, 9, 12, 15, 18, and 20. Body weight change was recorded for gestational days 0 to 6, 6 to 9, 9 to 12, 12 to 15, 15 to 18, 18 to 20, 6 to 20, and 0 to 20.
FOOD CONSUMPTION: Yes
- Food consumption reported as g food consumed/animal/day for gestational days 0 to 6, 6 to 9, 9 to 12, 12 to 15, 15 to 18, 18 to 20, 6 to 20, and 0 to 20.
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 20
- Organs examined: Uterus, any other organ showing 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
- Other: Position of cervix, gross examination of placentae, location of viable and non-viable fetuses, and location of early and late resorptions - Fetal examinations:
- - External examinations: Yes: [all per litter]
- Soft tissue examinations: Yes: [all per litter]
- Skeletal examinations: Yes: [all per litter]
- Head examinations: No - Statistics:
- Differences between groups were assessed using Levene’s test, Dunnett’s test, Welch’s test with a Bonferroni correction, Fischer’s exact test with a Bonferroni correction, Chi-square test, Kruskal-Wallis test, Mann-Whitney U-test, and Pearson Chi-square test.
- Indices:
- None reported
- Historical control data:
- Yes
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
Discoloured feces was observed in 77 and 100% of the animals in the 400 and 1000 mg/kg groups, respectively. Although this observation was considered to be treatment-related, it was likely due to the presence of the test article in the feces, and its toxicological significance is unknown.
One dam in the 1000 mg/kg group had a liver adhesion and a nodule on the right kidney, and 1 dam in the 100 mg/kg group had granular material on the surface of the right kidney. These findings were considered to be spontaneous and not treatment-related.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOEL
- Effect level:
- 1 000 mg/kg bw (total dose)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOEL
- Effect level:
- 1 000 mg/kg bw (total dose)
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
One fetus in the 1000 mg/kg group had omphalocele, and another fetus in the 1000 mg/kg group (from a different litter) had an absent tail and anal atresia. These findings were considered to be spontaneous and not treatment-related.
Vertebral malformation was observed in 7.1% of fetuses in the 1000 mg/kg group, compared to 0% in the control group. Slight increases in the incidence of rudimentary ribs and misaligned sternebra were noted in the 100 and 1000 mg/kg groups compared to the control. The incidence of misaligned sternebra and vertebral malformations were considered to be within historical control ranges, and were therefore not considered biologically relevant or treatment-related. Although the incidence of rudimentary ribs was slightly above the historical control range, a dose-related pattern was not observed, and there was no significant difference in incidence compared to the control group. Thus, the incidence of rudimentary ribs was not considered to be biologically relevant or treatment-related.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
As no adverse maternal or fetal effects were observed following the administration of 100, 400, or 1000 mg/kg/day to rats between gestational days 6 and 19, the results of this study indicate that test substance is not teratogenic to rats.
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.
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.
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