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EC number: 221-242-5 | CAS number: 3039-83-6
- 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
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- Flash point
- Auto flammability
- Flammability
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- 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
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
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- Endpoint summary
- Stability
- Biodegradation
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- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010-02-23 to 2010-04-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented and reliable GLP compliant study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 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 ethylenesulphonate
- Reference substance name:
- The used aqueous test solution contained 25.4% Sodium ethylenesulphonate (CAS no. 3039-83-6)
- IUPAC Name:
- The used aqueous test solution contained 25.4% Sodium ethylenesulphonate (CAS no. 3039-83-6)
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material: Sodium ethylenesulphonate (Sodium vinylsulphonate)
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- Wistar
- 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
- Housing: In standard polypropylene cages with stainless stell top grill; females were housed in groups of 5 animals during pre mating period. Males were housed individually during pre mating and post mating. One male and one female were kept together in a cage until the confirmation of mating. After confirmation of mating females were caged individually.
- Diet: ad libitum,
- Water: reverse osmosis water, ad libitum
- Acclimation period: Five days prior to experiment in the test room.
ENVIRONMENTAL CONDITIONS
- Temperature: between 19.6 and 22.0°C
- Humidity: between 50 and 59%
- Photoperiod: 12 light and 12 dark conditions
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION ON ORAL EXPOSURE:
The test substance was suspended in distilled water to achieve the nominal concentrations for each dose level. The dose formulations were prepared daily. The stability of sodium ethylenesulphonate in the vehicle was determined.
VEHICLE:
- Sodium ethylenesulphonate concentration in vehicle: 12.5, 25, 50 mg/mL
- Amount of vehicle: 10 mL/kg bw (dose volume) - Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- Range Finding Study
- 7 days
Main Study
- at least 28 days
Dosing of both 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 was completed and then sacrificed. Dosing of mating confirmed females was continued throughout gestation until day 4 post partum. - Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 500 mg/kg bw/day
- Remarks:
- Based on a 25% Sodium ethylenesulfonate solution
Basis: actual ingested
- Dose / conc.:
- 1 000 mg/kg bw/day
- Remarks:
- Based on a 25% Sodium ethylenesulfonate solution
Basis: actual ingested
- Dose / conc.:
- 2 000 mg/kg bw/day
- Remarks:
- Based on a 25% Sodium ethylenesulfonate solution
Basis: actual ingested
- No. of animals per sex per dose:
- Range Finding Study
- 3 rats
Main Study
- 10 rats - Control animals:
- yes, concurrent vehicle
- Details on study design:
- DOSE SELECTION RATIONALE:
The dose levels for the main study were selected based in the results of a 7 day range-finding study which revealed no test substance-related finding (viability, clinical signs, macroscopical examination) up to and including the highest dose level of 2000 mg/kg bw, corresponding to 500 mg/kg bw/day in terms of pure Sodium etyhlenesulphonate.
MATING PROCEDURE
1:1 (one male to one female) mating was followed in this study. The females were housed with the same males until pregnancy occured.
Examinations
- Maternal examinations:
- OBSERVATION PERIOD
Males were observed for 28 days and females were observed during premating (14 days), mating (1-6 days), and gestation (20-23 days), parturition and till day 4 post partum.
MORBIDITY/MORTALITY
All animals were observed twice daily for morbidity/mortality during the entire observation period.
DETAILED CLINICAL OBSERVATIONS
All animals were observed for toxicity signs once daily, preferably after dosing in the morning.
NEUROBEHAVIOURAL EXAMINATION
Functional observation battery (FOB) including auditory function, grip strength and locomotor activity assessment was conducted in selected 5 males and 5 females from each group. In males, FOB was conducted shortly before scheduled kill but before blood sampling for hematology or biochemistry. Females were tested for FOB during lactation, shortly before scheduled kill.
BODY WEIGHT
Body weight of individual male and female rats were recorded prior to the administration of the test substance (day 0) and weekly thereafter. During pregnancy, females were weighed on day 0, 7, 14 and 20 of pregnancy and within 24 hours of parturition (day 0 or 1 post-partum) and on day 4 post-partum.
FOOD CONSUMPTION
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.
BLOOD COLLECTION
Blood was collected from orbital sinus in heparinised vials (for biochemistry) as well as in vials containing EDTA (for hematology) from 5 males and 5 females from each group. 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.
HEMATOLOGY
The following parameters were determined:
Erythrocyte (RBC) count,
Hemoglobin (Hb) concentration,
Hematocrit (HCT),
Mean corpuscular volume (MCV),
Mean corpuscular hemoglobin (MCH),
Mean corpuscular hemoglobin concentration (MCHC),
Platelet count,
Total leucocyte (WBC) count,
Differential leucocyte count,
Clotting time.
CLINICAL CHEMISTRY
The following parameters were determined:
Glucose,
Urea,
Blood urea nitrogen (BUN),
Creatinine,
Total cholesterol,
Triglycerides,
Albumin,
Total protein,
Alanine aminotransferase (ALT),
Aspartate aminotransferase (AST),
Alkaline phosphatase (ALP),
Calcium,
Phosphorus,
Sodium,
Potassium
MATING CONFIRMATION/EVIDENCE OF COPULATION
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.
SACRIFICE
Dams with offspring were sacrificed on day 4 post partum. Females which failed to deliver were sacrificed 26 days after the last day of mating period. Pups were sacrificed at day 4 post partum.
GROSS PATHOLOGY
Adult animals were examined macroscopically for any abnormalities and pathological changes. The number of implantation sites was recorded and the counting of corpora lutea was done. Special attention was paid to the organs of the reproduction system. The ovaries, testes, epididymis, accessory sex organs and all organs showing macroscopic lesions of all adult animals were preserved. Of the selected five males and five females, the following tissues were preserved in 10% neutral buffered formalin and intended for subsequent histopathological examination: all gross lesions, brain (representative regions including cerebrum, cerebellum and pons), spinal cord, stomach, small and large intestines (including Peyer's patches), liver, kidneys, adrenals, spleen, heart, thymus, thyroid, trachea and lungs, uterus, urinary bladder, mesenteric lymph nodes, mandibular lymph nodes, peripheral nerve (sciatic), and a section of bone marrow. Bone marrow aspirate was collected for bone marrow cytology.
ORGAN WEIGHT
Weights of following organs of all male adult animals were recorded.
1. Testes
2. Epididymis
In addition, weights of following organs for 5 adult males and females selected from each group was determined: liver, kidneys, adrenals, thymus, spleen, mesenteric lymph nodes, mandibular lymph nodes, brain and heart.
BONE MARROW CYTOLOGY
Bone marrow aspirate was conducted in selected 5 males and 5 females from each group for bone marrow cytology during necropsy.
HISTOPATHOLOGY
Detailed histological examination was performed on all the animals of control and high dose group with special emphasis on stages of spermatogenesis and histopathology of interstitial testicular cell structure
1. Ovaries
2. Testes
3. Epididymis
In addition, full histopathological examination was carried out on the following tissues of the selected 5 males and 5 females of control and high dose group: all gross lesions, brain (representative regions including cerebrum, cerebellum and pons), spinal cord, stomach, small and large intestines (including Peyer's patches), liver, kidneys, adrenals, spleen, heart, thymus, thyroid, trachea, lungs, uterus, urinary bladder, mesenteric lymph nodes, mandibular lymph nodes, peripheral nerve (sciatic), and a section of bone marrow (sternum). - Fetal examinations:
- GESTATION LENGTH AND LITTER DATA
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. The duration of gestation length was recorded and was 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 0 post partum) and day 4 post partum. Sex ratio (m/f) was calculated using formula as below:
Sex ration (m/f)= (No. of male pups/No. of female pups) x 100 - Statistics:
- Body weight, food consumption, detailed 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 was homogeneous then it was analysed using ANOVA. (Student's Newman - Keufs Test was employed for post - hoc comparison). When the data was not homogeneous it was analysed with Kruskal-Wallis One-Way ANOVA on Rank basis.
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- no effects observed
Maternal developmental toxicity
- Details on maternal toxic effects:
- Details on maternal toxic effects:
MORTALITY
No morbidity/mortality was observed in any of the animals during the entire observation period.
SIGNS OF TOXICITY
Test substance related signs of toxicity were not observed in any of the treated group throughout the observation period. No abnormal behavior was observed in offsprings.
BODY WEIGHT
No statistically significant changes were observed in body weights of males and females of treated groups when compared with the control group.
FEED CONSUMPTION
Test substance related statistically significant changes were not observed in feed consumption of males and females of treated groups when compared with the control group.
HEMATOLOGY
Statistically significant changes were not observed in hematology parameters of the treated groups when compared with the control group, except a slight decrease in mean corpusular volume (MCV) in the blood of the high dose males at day 28, which was well within normal limit and considered of no biological significance.
BIOCHEMISTRY
Statistically significant changes were not observed in biochemistry parameters of low, mid and high dose group of animals when compared with the control group animals.
FUNCTIONAL OBSERVATION BATTERY
No test substance related effects were observed in functional observational battery (FOB) parameters in treated groups of males (low, mid and high dose groups) and in the control group male animals. However, in females (500 mg/kg bw) auditory function (acoustic startle) was increased when compared to control group female animals.
MATING PERIOD/EVIDENCE OF COPULATION
No test substance related effect were observed on mating/mating period duration of females in treated groups and in the control group.
GESTATION LENGTH
There was no test substance related effect on gestation length of dams in any of the treated groups when compared to the control group.
IMPLANTATIONS
No test substance related effect was observed on the mean number of implantation sites in any of the treated groups when compared with the control group.
MEAN LITTER SIZE
No test substance related effect was observed on mean litter size in any of the treated groups when compared to the control group at day 0 and day 4 post partum.
MEAN LITTER SIZE
No test substance related effect was observed in mean litter weight on day 0 and day 4 post partum in any of the treated groups when compared with control group.
DAM WITH LIVE PUPS
No test substance related effect was observed on the number of dams delivered with live pups in any of the treated groups as compared to control.
LOSS OF OFFSPRINGS
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.
ORGAN WEIGHT CHANGES
No statistically significant changes were observed in both absolute and relative organ weights in any of the treatment groups when compared with the control group.
BONE MARROW CYTOLOGY
No statistically significant changes were observed in bone marrow cytology in any of the treatment groups when compared with the control group.
GROSS PATHOLOGY
No test substance related gross pathological changes were observed in any of the treated and control group. All macroscopic findings were either related to agonal, spontaneous, or incidental lesion were of the type routinely observed in Wistar rats of this age.
HISTOPATHOLOGY
No test substance related adverse histopathological findings were observed in the high dose group. All microscopic findings were either related to agonal, spontaneous, or incidental lesions were of the type routinely observed in Wistar rats of this age.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- > 500 mg/kg bw/day (nominal)
- Based on:
- act. ingr.
- Basis for effect level:
- other: Effect type not specified.
- Remarks on result:
- other: No test substance related findings were noted up to and including the high dose level. Dose level given in terms of pure Sodium ethylenesulphonate (This dose level was reported as 2000 mg/kg bw/day of a 25 % solution).
Maternal abnormalities
- Abnormalities:
- no effects observed
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- no effects observed
- Changes in postnatal survival:
- no effects observed
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- no effects observed
- Other effects:
- no effects observed
- Details on embryotoxic / teratogenic effects:
- Details on embryotoxic / teratogenic effects:
SEX RATIO OF PUPS
No test substance related effect was observed on sex ratio of the pups in any of the treated groups when compared with the control group.
EXTERNAL ABNORMALITIES IN PUPS
Gross external examination of live pups sacrificed on day 4 post-partum did not reveal any abnormality that could be attributed to the treatment.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day
- Based on:
- act. ingr.
- Basis for effect level:
- other: No Effects observed
- Remarks on result:
- other: No test substance related findings were noted up to and including the high dose level. Dose level given in terms of pure Sodium ethylenesulphonate (This dose level was reported as 2000 mg/kg bw/day of a 25 % solution).
Fetal abnormalities
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Developmental effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the combined repeated dose toxicity study in male and female rat with the test item, containing 25% Sodium ethylenesulphonate, the obtained NOAEL was greater than 2000 mg/kg bw/day for the tested solution. Based on this study the derived NOAEL for developmental toxicity in the F1 progeny for 100% Sodium ethylenesulphonate was greater than 500 mg/kg bw/day.
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