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EC number: 700-978-5 | 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
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Sodium ethylenesulphonate
- EC Number:
- 221-242-5
- EC Name:
- Sodium ethylenesulphonate
- Cas Number:
- 3039-83-6
- Molecular formula:
- C2H4O3S.Na
- IUPAC Name:
- sodium ethenesulfonate
- Test material form:
- liquid
- Details on test material:
- 25% solution in water
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Procured from Charles River, USA and bred at IIBAT animal house facility.
- Age at study initiation: Young adult rats, between 12 and 14 weeks old. Females were virgin.
- Weight at study initiation: Males: 326-407g; Females: 241-287g. The weight variation in animals involved in the study were not exceeded ± 20 % of the mean weight of each sex.
- Fasting period before study: no data
- Housing: Females were housed in groups in cages, each cage containing five animals in pre mating period. Males were housed individually during pre mating. One male and one female kept together in a cage until the confirmation of mating occurs. After confirmation of mating females were caged individually.
- Diet (e.g. ad libitum): Animals received ad libitum standard gamma irradiated pelleted food supplied by M/s. Tetragon Chemie Pvt. Ltd., Bangalore, India.
- Water (e.g. ad libitum): Reverse osmosis water was provided to animals ad libitum.
- Acclimation period: Five days prior to experiment in the test room.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): between 19.6 – 22.0°C
- Humidity (%): relative humidity between 50 – 59%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12h light and 12h dark
IN-LIFE DATES: From: To:78
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Distilled water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
DIET PREPARATION
- Rate of preparation of diet (frequency): no data
- Mixing appropriate amounts with (Type of food): no data
- Storage temperature of food: no data
VEHICLE
distilled water - Details on mating procedure:
- 1:1 (one male to one female) The females were housed with the same males until pregnancy occurs. Each morning the females were examined for the presence of sperm and/or vaginal plug. Day 0 of pregnancy is defined as the day on which vaginal plug or sperm is observed
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Quantification was done by HPLC-UV method. Stability study showed that 87 % recovery was observed for all concentrations tested, i.e. 500; 1000; 2000 mg/kg bw
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- The test substance was administered daily. Dosing of both the sexes began 2 weeks prior to mating, after acclimatization. Dosing was continued in both sexes during the mating period. Males were further dosed after the mating period until the minimum dosing period of 28 days has been completed and then sacrificed.
Dosing of mating confirmed females was continued throughout gestation and including day 3 post partum.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 2 000 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Dose / conc.:
- 500 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- Eighty animals were randomized into four groups, each consisting of 10/sex.
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: based on results of range finding study
- Rationale for animal assignment (if not random): random
- Rationale for selecting satellite groups: no data
- Post-exposure recovery period in satellite groups: no data
- Section schedule rationale (if not random): - Positive control:
- no data
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: no data
- Time schedule: Males were observed for 28 days and females were observed during premating (14 days), mating (1-6 days), and gestation (22-23 days), parturition and till day 4 post partum.
- Cage side observations checked in table [No.?] were included.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule:Once before the first exposure and once a week thereafter, detailed clinical observations will be made in all animals. These observations will be made in the home cage, handling observations and in a standard arena (open field), preferably at the same time, each day.
BODY WEIGHT: Yes
- Time schedule for examinations: Body weight of individual male and female were recorded prior to the administration of the test substance (day 0) and weekly thereafter. During pregnancy, females were weighed on days 0, 7, 14 and 20 of pregnancy and within 24 hours of parturition (day 0 or 1 post-partum) and day 4 post-partum.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Feed consumption was recorded daily during pre-mating (cage wise), pregnancy and lactation in females. The Feed consumption was not recorded during mating period. In males, feed consumption was recorded daily only during pre-mating.
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
OPHTHALMOSCOPIC EXAMINATION: No data
HAEMATOLOGY: Yes
- Time schedule for collection of blood:Blood was collected from orbital sinus in heparinised vials (for biochemistry) as well as in vials containing EDTA (for hematology). In males, it was done at the end of the pre-mating period and just prior to, the procedure for killing the animals. In females, it was done at the end of the pre-mating period and just prior to, the procedure for killing the animals.
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: females and males but not specified how many
- Parameters checked in table [No.?] were examined.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: see haematology
URINALYSIS: No data
NEUROBEHAVIOURAL EXAMINATION: No data
OTHER: - Sperm parameters (parental animals):
- parameters examined in parent generations: testes weight, an depididymus weigt
- Litter observations:
- the duration of gestation was recorded and is calculated from day 0 of pregnancy to the day of parturition. each litter was examined as earliest after delivery to establish the numbers and sex of pups,still births,live births,runts and the presence of gross abnormalities. live pups were counted and sexed,litters were weighed within 24 hours of parturition ( day 0post postpartum) and day 4 post partum.sex ratio (m/f) was calculated
- Postmortem examinations (parental animals):
- All surviving animals were sacrificed by CO2.
Parent animals were examined microscopically for any abnormality or pathological change special attention was paid to the organs of the reproductive system.
All gross pathological changes were recorded individually for each animal.
the number of implantation sites were recorded,and the counting of corpora lutea was done - Postmortem examinations (offspring):
- the pups will be euthanized by injection of 0.12 ml Thiopenal sodium solution on day 4 post partum, and were carefully examined externally for gross abnormalities.
Histopathology/organ weight: not conducted. - Statistics:
- Body weight, food consumption, detail signs of toxicity, FOB, hematology, biochemistry and organ weight, corpora lutea, implantations, litter data of rats belonging to the experimental groups assured for homogeneity. When the data is homogenies then it was analysed using ANOVA. (Student’s Newman – Keul’s Test was employed for post - hoc comparison). When the data is not homogeneous it was analysed with Kruskal-Wallis One-Way ANOVA on Rank basis.
- Reproductive indices:
- reproductive indices: Sex ratio's were calculated
Reproductive parameters were mean gestation lenght , mean litter size,number of implantation losses,mean corpura lutea - Offspring viability indices:
- mean live litter size, mean litter weight
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Description (incidence):
- No morbidity/mortality was observed in any of the animals during the entire observation period
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No statistical , significant changes were observed in body weight of males and females of treated groups when compared to control group.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- Test substance related statistically changes were not observed in fed consumption of males and females of treated groups when compared with control group.
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- Statistically significant changes were not observed in hematology parameters of all dose groups when compared with control, except a slight decrease in MCV of G4 male at day 28, which is well within normal limit and considered of no biological significant.
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- Statistically significant changes were not observed in biochemistry parameters of all dose groups when compared with control.
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- no effects observed
- Description (incidence and severity):
- No test substance related effects were observed in functional observation battery parameters in treated groups of males and in the control group of males.However in G2 females auditory function (acoustic startle) parameter was increased when compared to control group female animals
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Description (incidence and severity):
- detailed histological examination was performed on all animals of the control and the HD group on the ovaries, no test substance related effects were observed
- Reproductive function: sperm measures:
- not specified
- Description (incidence and severity):
- detailed histological examination was performed on all animals of the control and the HD group on the testes and epididymis, no test substance related effects were observed
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- No test substance related effect were observed on mating/mating period of females treated groups , when compared to the control
There was also no test substance related effect on gestation length of dams in any of the treated groups , when, compared to the control.
no test substance related effect was observed on mean implantation in any of the treated groups of animals when compared to the control.
no test substance related effect was observed on mean litter size in any of the treated groups of animals when compared to the control at day 0 and day 4 post partum.
no test substance related effect was observed on mean litter weight in any of the treated groups of animals when compared to the control.
no test substance related effect was observed on the number of delivered with live pups in any of the treated groups of animals when compared to the control.
no test substance related effect was observed on loss offspring (pre implantation,post implantation, and post natal) of in any of the treated groups of animals when compared to the control.
no test substance related effect was observed on sex ratio of the pups in any of the treated groups of animals when compared to the control.
Details on results (P0)
Effect levels (P0)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 2 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other:
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Target system / organ toxicity (P0)
- Critical effects observed:
- no
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- Gross external examination of live pups sacrificed on day 4 post-partum did not reveal any abnormality that could be attributed to the treatment.
- Mortality / viability:
- no mortality observed
- Description (incidence and severity):
- No test substance related effect was observed on loss of offspring (pre implantation,post implantation, and post natal) in any of the treated groups when compared with the control group of anaimals
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- Gross external examination of live pups sacrificed on day 4 post partum did not reveal any abnormality that could be attributed to the treatment
- Histopathological findings:
- no effects observed
Details on results (F1)
Effect levels (F1)
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- >= 2 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other:
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Target system / organ toxicity (F1)
- Critical effects observed:
- no
Overall reproductive toxicity
- Reproductive effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Based on the above findings it can be concluded that the dose 2000 mg/kg b.w. of Sodium Vinyl Sulphonate Solution (Provichem 2202) is non-toxic to Wistar rats in respect to combined repeated dose and Reproduction/Developmental toxicity, therefore the NOAEL of the test substance is regarded as >=2000 mg/kg body weight.
- Executive summary:
In a combined Repeated Dose Toxicity study with the reproductive/developmental toxicity screening Test (OECD 422), performed to GLP potential toxicity of the test item was evaluated in the rat.
In a preliminary 7 days range finding study the test item was administrated orally to three dose groups with three males and three females. 500, 1000 and 2000 mg/kg Bw/day of the test item was administrated dally for 7 days, and observed for mortality and sings of toxicity daily. Control animals were treated similar but with distilled water. No test item related mortality , signs of toxicity or macroscopic observations were observed. Based on the results of the DRF study the same three doses ie 500, 1000, an 2000 mg/kg Bw/day were elected for the main study.
The test item was administrated gavage to the rats of both sexes two weeks prior to mating, after acclimatization. Dosing was continued in both sexes during mating period. Males were further dosed after the mating period until the minimum dosing period of 28 days has been completed and then sacrificed. Dosing of mating confirmed females was continued throughout gestation and including day 3 post-partum. All dams were allowed to litter naturally and the size, weight of litter and sex of litter-mates were recorded at parturition( day 0) and at day 4 post-partum.
Females which failed to deliver were sacrificed 26 days after day of mating period.
No animals died (table 13) in any test article group ,and no test article related changes were observed in clinical signs (Table 6,13 and 14), body weight( Table 1,2,3,15,16 and 17), feed consumption (Table 4,5,19 and 20) ,Heamatology (Table 7, and 22) ,Biochemistry( table 8 and 23), Functional observation battery (FOB) (Table 12 and 27), bone marrow cytology and reproduction performance like fertility, mating period (Table 11and 24), gestation length (table 11and 25), mean corpora lutea( table 26), mean implantation losses (table 10 and 26), mean litter size( table 10 and 26), mean litter weight ( table 10,11,26) and sex ratio of offspring.(table 11,26)
Absolute and relative weight changes of testis and epididymis and other organs of treated groups were not statistically different when compared to control. Gross and histopathological observations of parent animals did not reveal any test substance related lesion in any of treated group. No test substance related external observations of pups were observed.
From the above observations it can be concluded that 500, 1000, and 2000 mg/kg Bw/day of sodium vinyl sulphonate is non toxic to the parent and the pup born to them and therefore ,the NOAEL of the the test substance is arrived at 2000 mg/kg Bw
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