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EC number: 209-151-9 | CAS number: 557-05-1
- 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:
- reproductive toxicity, other
- Remarks:
- repeated dose 28-days oral toxicity study
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Justification for type of information:
- Data from an experimental study report.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD guideline No. 407
- Principles of method if other than guideline:
- Repeated Dose 28-Days Oral Toxicity Study of test chemical in Sprague Dawley (SD) rats to determine toxicity to reproductive organ.
- GLP compliance:
- not specified
- Limit test:
- no
- Justification for study design:
- No data available
Test material
- Reference substance name:
- Zinc distearate
- EC Number:
- 209-151-9
- EC Name:
- Zinc distearate
- Cas Number:
- 557-05-1
- Molecular formula:
- C18H36O2.1/2Zn
- IUPAC Name:
- zinc distearate
- Details on test material:
- - Name of test material (as cited in study report):Zinc Distearate
- Molecular formula :C18H36O2.1/2Zn
- Molecular weight :632.3476 g/mol
- Substance type:Organic
- Physical state:Solid (Powder)
- Impurities (identity and concentrations):0.14 %
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on species / strain selection:
- No data available
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Details on test animal
TEST ANIMALS
- Source: Central Animal Facility (CAF), NIPER, Sector-67, S.A.S. Nagar, 160 062, Punjab, India.
- Age at study initiation: 7 to 8 weeks old
- Weight at study initiation: Male: 205.78-247.70 g, Female : 185.58-235.40 g
- Fasting period before study: No data available
- Housing: Animals were housed in sterilized solid bottom polypropylene cages with stainless steel grill tops with facilities for food, water bottles and bedding of clean paddy husk. The cages were suspended on stainless steel racks. Animals were identified by assigning a unique identification (ID) number written on the tail, also specified on individual cage tag.
- Diet (e.g. ad libitum): Standard laboratory sterile extruded pelleted rodent feed (Batch No. 0001642169) manufactured by Provimi Animal Nutrition India Pvt. Ltd., Bangalore, ad libitum.
- Water (e.g. ad libitum): Potable tap water filtered through Reviva Reverse Osmosis System (water filter cum purifier) of Eureka Forbes in polypropylene bottles with stainless steel sipper tubes. ad libitum.
- Acclimation period: Five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%):30-70 %,
- Air changes (per hr): 25 ± 5 air changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- Details on oral exposure
PREPARATION OF DOSING SOLUTIONS: Dose was freshly prepared prior to dosing on each day. Corn oil was used as a vehicle for this study.Test chemical was administered to each rat at the dose levels of 250, 500 and 1000 mg/kg in the dose volume of 5 ml/kg body weight. The chemical was weighed on a weighing balance. Then, it was transferred to calibrated falcon tube. Some quantity of the corn oil was added initially and vortexed. The sufficient quantity of vehicle was added to make up the required volume of dose.
DIET PREPARATION
- Rate of preparation of diet (frequency): No data available
- Mixing appropriate amounts with (Type of food): No data available
- Storage temperature of food: No data available
VEHICLE
- Justification for use and choice of vehicle (if other than water): Chemical was insoluble in water, the corn oil was used as vehicle to deliver the desired dose levels as it is also recommended in the toxicological evaluation guidelines.
- Concentration in vehicle: 0, 250, 500 and 1000 mg/kg/day
- Amount of vehicle (if gavage): 5 ml of corn oil
- Lot/batch no. (if required): Batch no. 51
- Purity: No data available - Details on mating procedure:
- No data available
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The tet chemical (250, 500 and 1000 mg) was weighed on balance and dissolved in 5 ml of corn oil. An aliquot (5µl) was taken from three different layers of the dose preparations and was mixed in toluene to make the final volume 1ml. The concentration of the substence in each layer was calculated using the calibration curve of standard (5 mg / ml toluene) by UV - Visible spectroscopy using Flex Station at 600 nm.
- Duration of treatment / exposure:
- 28 days.
- Frequency of treatment:
- Daily
- Details on study schedule:
- No data available
Doses / concentrations
- Remarks:
- 0, 250, 500 and 1000 mg/kg/body weight/day
- No. of animals per sex per dose:
- Total: 56
0 mg/kg/day: 7 male, 7 female
250 mg/kg/day: 7 male, 7 female
500 mg/kg/day: 7 male, 7 female
1000 mg/kg/day: 7 male, 7 female - Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data available
- Positive control:
- No data available
Examinations
- Parental animals: Observations and examinations:
- Observations and examinations performed & frequency
CAGE SIDE OBSERVATIONS: Yes
- Time schedule : Twice daily (morning and evening)
- Cage side observations checked in table [No.?] were included. : Viaibility or moribund
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Daily for behavioral changes or reaction to treatment and detailed clinical signs were recorded weekly.
BODY WEIGHT: Yes
- Time schedule for examinations: On day 1, 8, 15, 22, 28, and day 29 (before schedule sacrifice)
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): No data available
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data available
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data available
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 available
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes
- Time schedule for examinations: Weekly once during 28 days of treatment. - Oestrous cyclicity (parental animals):
- No data available
- Sperm parameters (parental animals):
- No data available
- Litter observations:
- No data available
- Postmortem examinations (parental animals):
- Sacrifice and pathology
GROSS PATHOLOGY: Yes
All animals were sacrificed by CO2 asphyxiation. Complete necropsy was carried out on all the animals to score the gross lesions. Tissues were collected from all animals and preserved in 10% formal saline. However, testes, ovaries and uterus were first fixed in Bouin’s fixative for short duration then transferred to 10% formal saline.
HISTOPATHOLOGY: Yes
The required tissues for histology slide preparations were embedded in paraffin wax, five micrometers tissue sections were cut and stained with haematoxylin and eosin and examined for histopathological changes.
Organ examined: Brain, Stomach, Large intestine Small intestine, Liver, Kidneys, Adrenal gland(s), Spleen, Heart, Thymus, Lungs, Testis / Ovary, Uterus, Sciatic nerve Lymph nodes, Peripheral nerve (Sciatic) and Bone marrow were examined. - Postmortem examinations (offspring):
- No data available
- Statistics:
- Statistical analysis was carried out by using Microsoft Excel and IBM SPSS statistics version-20.0. All analyses and comparisons were evaluated at the 5 % level, statistically significant differences (p ≤0.05) indicated by appropriate notation. The focus was to examine the mean differences and their significance between control and low dose group, control and mid dose group and control and high dose group. The statistical decision was taken by preparing the univariant GLM MODEL procedure was used to check the significance between above mentioned groups. For multiple comparisons Turkey’s HSD test was applied.
- Reproductive indices:
- No data available
- Offspring viability indices:
- No data available
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Soft stool, nasal discharge was observed in all male and female treated animals.
When treated with 250 mg/kg, crust around nostrils in male and perineum soiled with fecal matter in female were observed.
In 1000 mg/kg/dose, red crust around nostrils, perineum soiled and soft feces were observed in female rats. - Dermal irritation (if dermal study):
- not specified
- Mortality:
- no mortality observed
- Description (incidence):
- No mortality was observed in treated animals.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- When treated with 500 and 1000 mg/kg/day, In male rat, significant increase were observed. In female rats, significant increase in body weight were observed in 1000 mg/kg/day as compare to control.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- No change was observed in food consumption of male and female rat of treated groups.
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Description (incidence and severity):
- No change was observed among all treated male rat but in female rat significant decreased was observed on 4th week of 1000 mg/kg/day dose treatment
- Ophthalmological findings:
- no effects observed
- Description (incidence and severity):
- No abnormalities were observed in all treated dose groups rat.
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- In male rats, when treated with 1000 mg/kg/day testosterone, sodium, total proteins and total cholesterol level were significantly increased and SGOT, SGPT were significantly reduced in treated rats.
Creatinine level was significantly reduced in 500 mg/kg/day treated male rats.
Potassium level was significantly increased in 250 mg/kg/day treated male rat.
When treaed with 1000 mg/kg/day, In female rats, significant reduction were observed in sodium, albumin and glucose level and Total Bile Acids, Potassium and SGPT were significant ly increased as compared to control.
When treated with 500 mg/kg/day, Potassium and SGPT significantly increased and glucose, blood urea nitrogen (BUN) and creatinine were significantly decreased in female treated rat.
When treated with 250 mg/kg/day, Potassium, SGPT and estrogen was significantly increased and SGOT were significantly decreased in female treated rat. - Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, non-treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Minimal increased were observed in eosinophils of small intestine, collapsed lung, minimal focal fatty change in liver were observed in 1000 mg/kg/day male rats. In female, minimal focal fatty change in liver, minimal reactive spleen and minimal increased in eosinophils of small intestine and mild changes were observed in liver with focal fatty change and reactive spleen was observed in 1000 mg/kg/day dose animals.However, the biological significance of these findings are not related to test chemical.
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- not specified
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
- body weight and weight gain
- food consumption and compound intake
- water consumption and compound intake
- ophthalmological examination
- clinical biochemistry
- organ weights and organ / body weight ratios
- gross pathology
- histopathology: non-neoplastic
- Remarks on result:
- other: No toxic effects on reproductive organ was observed
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- not specified
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Effect levels (F1)
- Dose descriptor:
- other: not specified
- Generation:
- other: not specified
- Based on:
- not specified
- Sex:
- not specified
- Basis for effect level:
- other: not specified
- Remarks on result:
- not measured/tested
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
- Treatment related:
- not specified
- Relation to other toxic effects:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Any other information on results incl. tables
Table: Summary of Body Weights
Treatment group |
Time (Days) |
|||||
1 |
8 |
15 |
22 |
28 |
Terminal day |
|
Males |
||||||
Control |
217.79 |
247.35 |
269.99 |
290.96 |
304.89 |
300.87 |
250 mg/Kg |
224.64 |
254.35 |
279.94 |
305.36 |
318.22 |
313.79 |
500 mg/Kg |
228.39 |
256.96 |
282.73 |
312.63 |
327.08 |
322.00 |
1000 mg/Kg |
233.18* |
261.44* |
284.33* |
312.10* |
322.86 |
319.86 |
Females |
||||||
Control |
194.50 |
206.76 |
217.21 |
231.38 |
234.65 |
231.10 |
250 mg/Kg |
195.28 |
206.89 |
215.12 |
225.92 |
232.35 |
229.71 |
500 mg/Kg |
199.97 |
214.31 |
224.03 |
235.82 |
241.54 |
238.41 |
1000 mg/Kg |
217.27* |
233.49* |
241.12* |
254.07* |
261.27* |
257.44* |
* Significant at p < 0.05 in comparison to control group
Table: Summary of Histopathology findings
Gross findings |
Dose groups |
|||||||
Males |
Females |
|||||||
G1 |
G2 |
G3 |
G4 |
G5 |
G6 |
G7 |
G8 |
|
Incidence (No. of Animals with Findings/ No. of Animals Examined) |
|
|
||||||
|
1/7 |
- |
- |
3/7 |
2/7 |
- |
- |
3/7 |
Lung |
|
|
||||||
Lung Collapsed |
- |
- |
- |
1/7 |
- |
- |
- |
- |
Liver |
|
|
||||||
Focal Fatty change |
- |
- |
- |
3/7 |
1/7 |
- |
- |
1/7 |
Small intestine |
|
|
||||||
Excess Lymphocyetes |
1/7 |
- |
- |
- |
- |
- |
- |
1/7 |
Spleen |
|
|
||||||
Reactive |
- |
- |
- |
- |
1/7 |
- |
- |
1/7 |
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 1000 mg/kg/bw/ day in male and female rats when exposed to test chemical for 28 days.
- Executive summary:
In 28 days repeated dose toxicity study, the effect of test chemical was evaluated in male and female Sprague Dawley rats. The test chemical was administered by oral gavage in the concentration of 0, 250, 500 and 1000 mg/kg/ body weight/day. The results showed no effect on mortality, no changes were in food consumption and ophthalmology. Changes were observed in clinical signs like soft stool, nasal discharge, red crust around nostrils, perineum soiled with fecal matter. Significant decreased were observed in water consumption and locomotor activity of female rat in1000 mg/kg dose group. Body weight was increased significantly in male and female rats. Significant changes were observed in the level of testosterone, sodium, total proteins, total cholesterol, SGOT, SGPT, albumin, Blood urea nitrogen (BUN) and Creatinine when treated with 500 and 1000 mg/kg/day. Significant changes were observed in absolute and relative weight of brain, adrenals, spleen, thymus, epididymides, heart, kidneys, ovaries, uterus and liver in 500 and 1000 mg/kg/day. In addition, minimal to mild gross pathological and histopathological changes were observed in liver, spleen and intestine. However, the biological significance of these findings are not related to test chemical. Therefore, NOAEL was considered to be 1000 mg/kg/day when Sprague-Dawley rat exposed to test chemical orally.
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