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EC number: 200-579-1 | CAS number: 64-18-6
- 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
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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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- Sodium formate
- EC Number:
- 205-488-0
- EC Name:
- Sodium formate
- Cas Number:
- 141-53-7
- Molecular formula:
- CHO2Na
- IUPAC Name:
- sodium formate
- Details on test material:
- - Name of test material (as cited in study report): Sodium formate
- Analytical purity: 100%
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- - Species: rabbit
- Strain: Himalayan
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH (former Charles River Laboratories, Germany)
- Sex: female
- Number: 25 per group
- Age: 13-21 weeks at study initiation
- Body weight (group mean): 2560 g
- Mating: Insemination; day of insemination designated day 0 of the study
Administration / exposure
- Route of administration:
- oral: gavage
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
For the preparation of the solutions, an appropriate amount of the test substance was weighed in a graduated measuring flask depending
on the dose group, topped up with doubly distilled water and subsequently thoroughly mixed until it was completely dissolved.
VEHICLE
- Amount of vehicle (if gavage): dose volume: 10 mL/kg bw - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- HPLC with external calibration. Column Synergi 4µ Hydro-RP 80 A, 250 x 3 mm. Eluant: phsophate buffer pH 2.9. UV-detection at 200 nm (report, page 229 onwards).
- Details on mating procedure:
- Artificial insemination:
After an acclimatization period of at least 5 days, the does were fertilized by means of artificial insemination.
This implied that 0.2 ml of a synthetic hormone which releases LH and FSH from the anterior pituitary lobe (Receptal®) were
injected intramuscularly to the female rabbits about 1 hour before insemination. The ejaculate samples used for the artificial insemination
were derived from male Himalayan rabbits of the same breed as the females. Each female was inseminated with the sperm of a defined male donor as documented in the raw data. The male donors were kept under conditions (air conditioning, diet, water) comparable to those of
the females participating in this study.
The day of insemination was designated as day 0 (beginning of the study) and the following day as day 1 post insemination (p.i.). - Duration of treatment / exposure:
- days 6-28 post implantation
- Frequency of treatment:
- daily
- Duration of test:
- 22 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 100, 300 and 1000 mg/kg body weight/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 25 females
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Sex: female
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Clinical signs: checked each day
- Mortality: checked twice daily on working days, once on Saturday, Sunday, at public holidays
DETAILED CLINICAL OBSERVATIONS: Yes / No / No data
- Time schedule:
BODY WEIGHT: Yes
- Time schedule for examinations: recorded regularly throughout the entire study period, i.e. on days 0, 2, 4, 6, 9, 11, 14, 16, 19, 21, 23, 25, 28 and 29 p.i.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes.
Food consumption was recorded daily throughout the entire study period.
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day # 29
- Organs examined: all females were sacrificed and assessed by gross pathology (including weight determinations of the unopened uterus and the placentae). For each doe, corpora lutea were counted and number and distribution of implantation sites (differentiated by resorptions, live and dead fetuses) were determined. Number and distribution of implantations sites were classified as live fetuses and dead implantations. Dead implantations comprised early resorptions, late resorptions and dead fetuses. - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Placenta weight: yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: all per litter
- Skeletal examinations: Yes: all per litter
- Head examinations: Yes: half per litter - Statistics:
- Simultaneous comparison of all dose groups with the control group using the DUNNETT-test (twosided) for the hypothesis of equal means * for p < 0.05, ** for p < 0.01: Food consumption, body weight, body weight change, corrected, body weight gain (net maternal, body weight change), carcass, weight, weight of unopened, uterus, number of corpora lutea, number of implantations, number of resorptions, number of live fetuses, proportions of preimplantation loss, proportions of postimplantation loss, proportions of resorptions, proportion of live fetuses in each litter, litter mean fetal body weight, litter mean placental weight.
Pairwise comparison of each dose group with the control group using FISHER'S EXACT test (one-sided) for the hypothesis of equal proportions * for p < 0.05, ** for p < 0.01: Female mortality, females pregnant at terminal sacrifice, number of litters with fetal findings.
Pairwise comparison of each dose group with the control group using the WILCOXON-test (onesided) for the hypothesis of equal medians * for p < 0.05, ** for p < 0.01: Proportions of fetuses with malformations, variations and/or unclassified observations in each litter. - Indices:
- Conception rate, pre- and postimplantation loss
- Historical control data:
- Included in Part III of the report
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
No clinical signs of toxicity, no treatement-related mortalities. Food consumption, body weights, necropsy findings not affected.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
Fetal weight, sex distribution, placenta weight not affected. Pre- and postimplantation loss not affected. External, soft tissue and skeletal malformations not affected by treatment.
Effect levels (fetuses)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: embryotoxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- 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
Analysis of Test Substance
By various analyses, the stability of the test substance
solutions over a period of 13 days at room temperature was
demonstrated, and the correctness of the prepared
concentrations was shown.
EFFECTS
1 - Parental animals
Mortalities: none in any of the groups.
Clinical signs: none in any of the groups (Report, p. 34)
Food consumption: comparable across all groups, no relevant
difference in treated groups compared to the control group
(Report, p. 35).
Body weights: comparable across all groups, no difference in
treated groups compared to the control group ((Report p.
36).
Corrected body weight gain: did not reveal statistically
significant differences between the test substance-treated
groups and the control group (Report p. 36)
Uterus weight: no effect; the mean uterus weights were
comparable between all groups (Report p. 37)
Necropsy findings: no test-substance related effect noted
(Report p. 37)
Table1:
Selected results for does in test groups 0 - 3,
i.e. at 0, 100, 300, or 1000 mg/kg bw per day
===========================================================
Parameter Group 0 Group 1 Group 2 Group 3
-----------------------------------------------------------
Females mated/
pregnant/ 25/24/24 25/23/23 25/22/22 25/23/23
with viable
fetuses
Food con-
sumtion (g) 100.5 97.8 94.5 94.6
day 0-29 (97%) (94%) (94%)
Body weight 306.0 323.5 260.5 297.7
gain (g) (106%) (85%) (97%)
day 0-29
Necropsy - - No treatment-related findings - -
findings
in dams
Conception 96 92 88 92
rate (%)
Abortions 0 0 0 0
Corpora lutea 201/24 196/23 193/22 185/23
total/number
of dams
Implantations 176/24 185/23 156/22 161/23
total/number
of dams
Resorptions 13/24 16/23 19/22 22/23
total/number
of dams
total number 163 169 137 139
of fetuses
total number 24 23 22 23
of litters
pre-implantation 12.5(19.1) 6.7(11.9) 18.4(24.9) 13.3(16.1)
loss (+/- SD) %
post-implantation 7.3(10.1) 7.9(9.3) 13.0(16.4) 13.9(16.2)
loss (+/- SD) %
fetuses/litter 6.8(2.25) 7.3(1.7) 6.2(2.5) 6.0(2.0)
(+/- SD)
live fetuses/ 92.7(10.1) 92.1(9.3) 87.0(16.4) 86.1(16.2)
litter (+/- SD) %
placenta weight 4.7 4.5 4.6 4.3
(mean) [g] (96%) (98%) (92%)
fetus weight 37.8 36.4 36.7 35.2
(mean) [g] (96%) (97%) (93%)
Fetal sex ratio 38.7:61.3 50.9:49.1 54.0:46.0 51.1:48.9
[ratio m : f]
===========================================================
SD = Standard Deviation
2 - Fetuses
There were no test substance-related effects in any of the
test groups at 100, 300, and 1000 mg/kg bw/day.
Table 2: Selected results for fetuses in test groups 0 - 3,
i.e. from does at 0, 100, 300, or 1000 mg/kg bw per day:
===========================================================
Parameter Group 0 Group 1 Group 2 Group 3
-----------------------------------------------------------
Total external malformations [%]
Fetuses 0.0 0.0 0.7 0.7
Litter 0.0 0.0 4.5 4.3
Affect. fetuses 0.0 0.0 0.6 0.5
per litter
Total external variations [%]
Fetuses 4.3 0.6 2.2 1.4
Litter 13 4.3 9.1 8.7
Affect. fetuses 2.3 0.9 2.0 1.4
per litter
Skeletal malformations [%]
Fetuses 1.8 1.8 1.5 3.6
Litter 13 13 9.1 22
Affect. fetuses 2.3 2.0 1.0 3.4
per litter
Skeletal variations [%]
Fetuses 52 65 60 65
Litter 100 91 95 96
Affect. fetuses 53.5 61.8 62.2 65.7
per litter
Soft tissue malformations [%]
Fetuses 1.2 0.6 2.2 4.3
Litter 8.3 4.3 14 26
Affect. fetuses 1.5 0.5 2.1 4.5
per litter
Soft tissue variations [%]
Fetuses 4.3 11 11 10
Litter 21 48 41 39
Affect. fetuses 4.2 10.9 9.4 8.9
per litter
===========================================================
Applicant's summary and conclusion
- Conclusions:
- Result: negative; no maternal and prenatal developmental toxicity, no teratogenicity at any tested dose level.
- Executive summary:
In a developmental toxicity study sodium formate was administered to 25 female Himalayan rabbits in water by gavage at dose levels of 0, 100, 300, and 1000 mg/kg bw/day from days 6 through 28 of gestation.
There were no treatment-related effects in mortality, clinical signs, body weight, food consumption,cesareanparameters, and terminal necropsy in the does. The maternal NOAEL is therefore 1000 mg sodium formate/kg bw/day.
There were no treatment-related effects in developmental parameters.Fetal weight at birth, sex distribution, placenta weight, pre- and postimplantation loss was not affected. There were no unusual or increased incidences of external, soft tissue or skeletal malformations attributable to the treatment. The developmental NOAEL is therefore 1000 sodium formate mg/kg bw/day.The NOAEL for teratogenicity is also 1000 sodium formate mg/kg bw/day, the highest dose tested.
The developmental toxicity study in the rabbit is classified acceptableand satisfies the guideline requirement for a developmental toxicity study (OECD 414) in rabbits.
Generally, formate salts are used as test material in studies requiring repeated dosing, due to the corrosivity of formic acid. NOAEL values obtained in such studies may be used to calculate the NOAEL for the formate anion which may be read across to other salts or formic acid, taking into account stoichiometry and formula weights. For the ease of the reader, this is tabulated below (calculation in brackets).
Table: calculation of NOAEL values
Formula
weight
NOAEL
maternal toxicityNOAEL
developmental toxicityNOAEL
teratogenicity(mg/kg bw/day)
Sodium formate
69
1000
1000
1000
Formate anion
45
652
(1000/69x45)652
(1000/69x45)652
(1000/69x45)Formic acid
46
667
(1000/69x46)667
(1000/69x46)667
(1000/69x46)
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