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EC number: 500-020-4 | CAS number: 9005-67-8 1 - 6.5 moles ethoxylated
- 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:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from publication.
Data source
Reference
- Reference Type:
- publication
- Title:
- TERATOLOGY STUDY OF TEST CHEMICAL IN RATS
- Author:
- Ema, M. et al
- Year:
- 1 988
- Bibliographic source:
- Drug Chem. Toxicol. (1977) 1988, 11(3), 249-260
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Principles of method if other than guideline:
- To examine the teratogenic potential of test chemical given to pregnant rats during the organogenetic period.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Sorbitan monostearate, ethoxylated
- EC Number:
- 500-020-4
- EC Name:
- Sorbitan monostearate, ethoxylated
- Cas Number:
- 9005-67-8
- Molecular formula:
- C64-H126-O26 Unspecified
- IUPAC Name:
- Sorbitan monostearate, ethoxylated
- Details on test material:
- - Name of test material (as cited in study report): Sorbitan monostearate, ethoxylated
- Substance type: Organic
- Physical state: Liquid
Constituent 1
- Specific details on test material used for the study:
- - Substance type: Organic
- Physical state: Liquid
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- Details on test animals and env. conditions
TEST ANIMALS
- Source: No Data Available
- Age at study initiation: 12 weeks of age
- Weight at study initiation: (P) No Data
- Fasting period before study: No Data Available
- Housing: No Data Available
- Use of restrainers for preventing ingestion (if dermal): No
- Diet (e.g. ad libitum): basal diet (CE-2, Drug Clea Japan Inc., Tokyo) and tap water ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24+/- 1 oC
- Humidity (%): 55+/- 5 %.
- Air changes (per hr): No data Available
- Photoperiod (hrs dark / hrs light): No Data Available
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: feed
- Details on exposure:
- Pregnant rats were given test chemical at a dose of 0, 0.1 (99 mg/kg), 1.0 (960 mg/kg) or 10% (7693 mg/kg)of test chemical in the diet from day 7 to day 14 of pregnancy.
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data available
- Details on mating procedure:
- Virgin female rats of about 12 weeks of age were mated for 15 hours with male rats of same strain. The day when the spermatozoa in the vagina was detected was considered to be day 0 of pregnancy.
- Duration of treatment / exposure:
- Days 7-14 of gestation
- Frequency of treatment:
- Daily
- Duration of test:
- No data
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 0.1, 1.0 or 10%
Basis:
0.1% (99 mg/kg), 1.0% (960 mg/kg) or 10% (7693 mg/kg)
- No. of animals per sex per dose:
- No data
- Control animals:
- yes, plain diet
- Details on study design:
- No data available
Examinations
- Maternal examinations:
- The pregnant rats were observed for evidence of clinical signs of toxicity and weighed daily.
- Ovaries and uterine content:
- The peritoneal cavity and uterus were opened, and the numbers and positions of live and dead fetuses and resorptions were recorded.23
- Fetal examinations:
- The live fetuses removed from the uterus by cesarean section were sexed, weighed and inspected for external anomalies and anomalies within
the oral cavity.
About half of the fetuses in each litter were fixed in alcohol, cleared in KOH solution, stained with Alizarin Red S14 and examined for skeletal anomalies.
The remaining half of the fetuses in each litter were fixed in Bouin's solution, sectioned with a razor blade and examined for internal anomalies - Statistics:
- Statistical analysis of the data was carried out using the litter as a unit.Student's t-test, Wilcoxon's rank sum test, chi-square test with Yates' correction or Fisher's exact probability test was used. The level of significance chosen was p < 0.05.
- Indices:
- No data available
- Historical control data:
- No data available
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No significant difference was noted in the maternal body weight gain during the treatment period between the treated and control groups.
- Food consumption and compound intake (if feeding study):
- no effects observed
- 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
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Maternal developmental toxicity
- Number of abortions:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The incidences of intrauterine death in the 1.0 % (960mg/kg) group were significantly higher than that of the control group
- Pre- and post-implantation loss:
- effects observed, non-treatment-related
- Description (incidence and severity):
- In the 99 mg/kg group, the number of implantations per litter was significantly higher than that of the control group.
- Total litter losses by resorption:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The incidences of resorptions in the 1.0 % (960mg/kg) group were significantly higher than that of the control group. No significant effect on number of resorptions were observed in treated and control animals.
- Early or late resorptions:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The incidences of resorptions in the 1.0 % (960mg/kg) group were significantly higher than that of the control group. No significant effect on number of resorptions were observed in treated and control animals.
- Dead fetuses:
- no effects observed
- Description (incidence and severity):
- No significant effect were observed in live and dead fetuses per litter in treated and control animals.
- Changes in pregnancy duration:
- not specified
- Changes in number of pregnant:
- not specified
- Other effects:
- not specified
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 960 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- dead fetuses
- early or late resorptions
- effects on pregnancy duration
- food consumption and compound intake
- maternal abnormalities
- number of abortions
- organ weights and organ / body weight ratios
- pre and post implantation loss
- total litter losses by resorption
- Remarks on result:
- other: Not Specified
Maternal abnormalities
- Abnormalities:
- not specified
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- No change in the fetal body weight of both sexes were seen in any group at 99, 960 and 7693mg/kg
- Reduction in number of live offspring:
- not specified
- Changes in sex ratio:
- no effects observed
- Description (incidence and severity):
- No change in the sex ratio of live fetuses of both sexes in any group at 99, 960 and 7693mg/kg
- Changes in litter size and weights:
- not specified
- Changes in postnatal survival:
- not specified
- External malformations:
- no effects observed
- Description (incidence and severity):
- Neither external anomalies were found in any group at 99, 960 and 7693mg/kg
- Skeletal malformations:
- no effects observed
- Description (incidence and severity):
- Neither skeletal anomalies were found in any group at 99, 960 and 7693mg/kg
- Visceral malformations:
- no effects observed
- Description (incidence and severity):
- No visceral abnirmalities were seen in any group at 99, 960 and 7693mg/kg
- Other effects:
- not specified
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 7 693 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: teratogenicity
- Remarks on result:
- other: not specified
Fetal abnormalities
- Abnormalities:
- not specified
- Localisation:
- other: not specified
- Description (incidence and severity):
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
- Treatment related:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Based on the observations the NOAEL for the test chemical was considered to be 7693mg/kg in Wistar rats
- Executive summary:
The present study aimed, to examine the teratogenic potential of test chemical given to pregnant rats during the organogenetic period. The mating was done by using Virgin female rats of about 12 weeks of age were mated for 15 hours with male rats of same strain. The day when the spermatozoa in the vagina was detected was considered to be day 0 of pregnancy. In this study the pregnant Wistar rats were given test chemical at a dose of 0, 0.1 (99 mg/kg), 1.0 (960 mg/kg) or 10% (7693 mg/kg) in the diet from day 7 to day 14 of pregnancy. The treated female rats observed for evidence of clinical signs of toxicity and weighed daily. On day 20 of pregnancy, the pregnant rats in each group were killed by cervical dislocation. The peritoneal cavity and uterus were opened, and the numbers and positions of live and dead fetuses and resorptions were recorded. The live fetuses removed from the uterus by cesarean section were sexed, weighed and inspected for external anomalies and anomalies within the oral cavity. About half of the fetuses in each litter were fixed in alcohol, cleared in KOH solution, stained with Alizarin Red S14 and examined for skeletal anomalies. The remaining half of the fetuses in each litter were fixed in Bouin's solution, sectioned with razor blade and examined for internal anomalies.The results of the study revealed, No significant difference in the maternal body weight gain during the treatment period between the treated and control groups. The maternal developmental toxicity results revealed, the incidences of intrauterine death in the 1.0 % (960mg/kg) group were significantly higher than that of the control group however no such effects were seen in treated group at 96 and 7693mg/kg. In the 99mg/kg group, the number of implantations per litter was significantly higher than that of the control group. The incidences of resorptions in the 1.0 % (960mg/kg) group were significantly higher than that of the control group. No significant effect on number of resorptions were observed in treated and control animals. No significant effect were observed in live and dead fetuses per litter in treated and control animals. No change in the sex ratio of live fetuses and the fetal body weight of both sexes. No other maternal toxicty effects were observed. When the fetuses toxicity examined no change in the sex ratio of live fetuses and the fetal body weight of both sexes weight were observed. Neither external, skeletal and vesceral anomalies were observed in any treated groups at 99, 960 and 7693mg/kg. Thus, based on the observations and results of the study, the NOAEL for the test chemical was considered to be 7693mg/kg in Wistar rats.
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