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Diss Factsheets
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EC number: - | 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant guideline study
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:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 83-3 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4900 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Details on test material:
- - Test article: CGA65047 SG 100 (A-5787 A)
- Physical state: granules
- Lot/batch No.: P.201845
- Storage condition of test material: room temperature
- Analytical purity: 100 % (UVCB)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Sprague-Dawley derived; Tif:RAIf (SPF); hybrids of RII/1 x RII/2
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Animal Production, WST-455, CIBA-GEIGY Limited, 4332 Stein, Switzerland
- Age at mating: minimum 8 weeks
- Weight range on gestation day 0: 176.8-231.5 g (females)
- Diet: pelleted, certified standard diet (Nafag No. 890, tox; Nafag, Nähr- und Futtermittel AG, Gossau, Switzerland), provided ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 50 ± 20 %
- Air changes: about 16 air changes/hour
- Photoperiod: 12 hours dark / 12 hours light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 0.5 % (w/w) aqueous solution
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS
Test substance-vehicle mixtures were prepared with a high speed homogeniser. Homogeneity of the mixtures during administration was maintained with a magnetic stirrer.
VEHICLE
A 0.5 % (w/w) aqueous solution of sodium carboxymethyl cellulose (CMC) was used
- Concentration in vehicle: 0, 0.5, 10.0 and 50.0 mg/mL mixture
- Amount of mixture: 10 mL/kg bw - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Samples of test substance-vehicle mixtures were taken once before (samples taken from top, middle and bottom of the container) and once after dosing (sample taken from middle of the container) and analysed for content, homogeneity and stability of the test item in the vehicle.
- Details on mating procedure:
- - Impregnation procedure: cohoused
- M/F ratio per cage: 1/3
- Length of cohabitation: 3-6 hours
- The mating procedure was repeated for non-pregnant females
- Verification of same strain and source of both sexes: yes
- Proof of pregnancy: vaginal plug or sperm in vaginal smear referred to as day 0 of pregnancy - Duration of treatment / exposure:
- from day 6 to day 15 of gestation
- Frequency of treatment:
- 1x/day
- Duration of test:
- 21 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 5, 100 and 500 mg/kg bw/day
Basis:
nominal conc.
- No. of animals per sex per dose:
- 24 rats
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale:
Dose levels were selected based on the results of a previous range finding study no. 941104 in pregnant rat.
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS:
- Time schedule: daily (incl. mortality)
BODY WEIGHT:
- Time schedule for examinations: daily
FOOD CONSUMPTION
- Time schedule for examinations: days 6, 11, 16 and 21
POST-MORTEM EXAMINATIONS:
- Sacrifice on gestation day 21
- Organs examined: main organs of the thoracic and abdominal cavities, in particular the genitals - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination.
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: uterine content assessment (live and dead foetuses, early and late losses) - Fetal examinations:
- - External examinations: Yes: [all per litter]
- Soft tissue examinations: Yes: [approximately half per litter]
- Skeletal examinations: Yes: [approximately half per litter]
- Head examinations: Yes: [all per litter] - Statistics:
- Statistical analysis of continuous data was performed using the Analysis of Variance Procedure (ANOVA) followed by Dunnett's t-test in case of a significant result in the ANOVA. Categorical data were analysed using Chi-Square test followed by Fisher's Exact test in case of a significant result in the Chi Square test. Non-parametric data were analysed during the Kruskal-Wallis non-parametric analysis of variance test followed by Mann-Whitney U-test.
- Indices:
- No indices were calculated
- Historical control data:
- Historical control data were included in the report.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
There was a reduction in mean food consumption and body weight gain during the second half of the dosing period at 500 mg/kg bw/day.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOEL
- Effect level:
- 100 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOEL
- Effect level:
- 500 mg/kg bw/day
- 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:
There was no indication for test item related embryotoxicity or teratogenic effects under the conditions of this study.
Effect levels (fetuses)
- Dose descriptor:
- NOEL
- Effect level:
- 500 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Chemical Analysis
Administration / Treatment 1:
The mean concentrations of the test item in the vehicle were 88.1 % (0.5 mg/mL) , 94.0 % (10 mg/mL) and 93.3 % (50 mg/mL) of the nominal concentrations for the low mid and high dose groups, respectively. The homogeneity varied in the range from -2 % to 4 % of the mean concentration. The test item was stable in the vehicle.
Administration / Treatment 2:
The mean concentrations of the test item in the vehicle were 94.9 % (0.5 mg/mL) , 93.9 % (10 mg/mL) and 94.1 % (50 mg/mL) of the nominal concentrations for the low mid and high dose groups, respectively. The homogeneity varied in the range from -1 % to 1 % of the mean concentration. The test item was stable in the vehicle.
Applicant's summary and conclusion
- Executive summary:
In a developmental toxicity study (CIBA-GEIGY, 1995), FeNa-EDDHA was administered once daily to groups of 24 mated female Sprague-Dawley derived rats by oral gavage at dose levels of 5, 100 or 500 mg/kg bw/day (10 mL/kg bw) from day 6 through day 15 of gestation. Control group females received the vehicle, 0.5 % (w/w) CMC in distilled water, only. The nominal concentrations, homogeneity and stability of the test item in the vehicle were confirmed by chemical analysis of dose formulations. All dams were sacrificed on day 21 of the gestation period and foetuses removed for examination. In dams, there were no treatment-related clinical signs or incidences of mortality. The body weight gain was reduced at 500 mg/kg bw/day for the period from days 6 -16 of gestation, and reduced food consumption was also noted at this dose level. No adverse effects on pregnancy and no embryo-/foetotoxic effects were observed. There was no indication of teratogenic potential. On the basis of these results, the NOEL was 100 mg/kg bw/day for maternal toxicity and 500 mg/kg bw/day for develomental toxicity and teratogenicity.
The developmental toxicity study in the rat is classified as acceptabel and satisfies the requirements of test guideline OECD 414.
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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