Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 211-077-7 | CAS number: 629-15-2
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP-Guideline study, tested with the source substance Sodium formate (CAS No. 141-53-7). According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Sodium formate
- EC Number:
- 205-488-0
- EC Name:
- Sodium formate
- Cas Number:
- 141-53-7
- 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:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH (former Charles River Laboratories, Germany)
- Age at study initiation: 13-21 weeks
- Body weight: 2560 g
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: 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:
- - Impregnation procedure: artificial insemination, day of insemination designated Day 0 of the study
- Duration of treatment / exposure:
- Days 6-28 post implantation
- Frequency of treatment:
- daily, 7 days/week
- Duration of test:
- 22 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
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
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
- Time schedule: animals were observed daily or more often when clinical signs of toxicity were elicited.
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: 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 (two-sided) 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 and 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 were not affected. External, soft tissue and skeletal malformations were 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.
Food consumption: comparable across all groups, no relevant
difference in treated groups compared to the control group.
Body weights: comparable across all groups, no difference in
treated groups compared to the control group.
Corrected body weight gain: did not reveal statistically
significant differences between the test substance-treated
groups and the control group.
Uterus weight: no effect; the mean uterus weights were
comparable between all groups.
Necropsy findings: no test-substance related effect noted.
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
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.