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EC number: 500-209-1 | CAS number: 68412-54-4 1 - 2.5 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:
- other: Study meets generally accepted scientific principles, acceptable for assessment.
Data source
Reference
- Reference Type:
- publication
- Title:
- Teratogenicity and in vitro mutagenicity studies on nonoxyl-9 and -30
- Author:
- Meyer O, Anderson PH, Hansen EV and Larsen JC
- Year:
- 1 988
- Bibliographic source:
- Parmacol. Toxicol. 62:236-238
Materials and methods
- Principles of method if other than guideline:
- Mol:WIST rats, 11 weeks of age, were mated. Mated females received NPE-9 (commercial formulation with an average ethoxylation grade of 9) by gavage or skin application from Gestation Day 6 - 15 or 1 -20 (only 500 mg/kg bw/day per oral). On Day 21, the rats were weighed, sacrificed and necropsied. The following parameters were recorded: weight of the intact uterus and ovaries, number of corpora lutae, implantation and fetuses, live and dead. The fetuses were weighed, their sex determined and they were examined for gross external malformations. Half of the fetuses were examined for skeletal abnormalities. The remaining fetuses were fixed in Bouins solution and sectioned. Weight of dams, sex ration of fetuses and pre- and post-implantation losses were calculated.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- NPE-9
- IUPAC Name:
- NPE-9
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Mol: WIST
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Molle-gards Breeding Center Ltd., Denmark
- Age at study initiation: 11 weeks
- Housing: stainless steel wire cages
- Diet (e.g. ad libitum): powdered chow (Chow 101)
- Water (e.g. ad libitum): acidified water, citric acid, pH 3.5, ad libitum
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1°C
- Humidity (%): 60 +/-5°C
- Air changes (per hr): 6-8
- Photoperiod (hrs dark / hrs light): 12:12
Administration / exposure
- Route of administration:
- other: oral and dermal
- Vehicle:
- water
- Details on exposure:
- ORAL
Application by gavage of the substance diluted in water.
DERMAL
The substance was injected into a porous dressing placed on shaved skin (3 x 6 cm) and covered by tape (Fixomul). - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- Gestation Day 6 to 15
- Frequency of treatment:
- Daily
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0, 50, 250, and 500 mg/kg bw/day
Basis:
nominal conc.
oral application
- Remarks:
- Doses / Concentrations:
0, 50 and 500 mg/kg bw/day
Basis:
nominal conc.
dermal application
- No. of animals per sex per dose:
- 19-25
Examinations
- Maternal examinations:
- Bodyweight of mated females on Days 1, 6, 9, 12, 15 and 21.
- Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes / No / No data
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Other: Number of fetuses, live and dead; ovary weight - Fetal examinations:
- - Fetus weight and sex
- External examinations: Yes: [all per litter]
- Soft tissue examinations: Yes: [half per litter]
- Skeletal examinations: Yes: [half per litter] - Statistics:
- Student's t-test was performed on bodyweight F0, weight gain F0, litter size, sex ratio, bodyweight F1, mean implantation weight of the intact uteri (inclusive ovaries), pre-and post-implantation loss.
The 'Qiock tes-chi-square" was used for special parameters in the teratogenicity test (Mainland 1963). - Indices:
- Weight of dams, sex ration of fetuses and pre- and post-implantation losses were calculated.
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- The dams given 250 mg NPE-9/kg bw/day orally on Days 6-15 and 500 mg/kg bw/day on Days 6-15 and 1-20 exhibited a statistically significant decrease in weight gain. All rats given epicutaneous doses, including controls, exhibited a marked decrease in bodyweight and weight gain during the treatment.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- A concomitant decrease in food consumption was observed in dams exposed to 500 mg/kg bw/day as compared to control.
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not specified
- Details on results:
- The dams given 250 mg NPE-9/kg bw/day orally on Days 6-15 and 500 mg/kg bw/day on Days 6-15 and 1-20 exhibited a statistically significant decrease in weight gain. A concomitant decrease in food consumption was observed in dams exposed to 500 mg/kg bw/day as compared to controls. All rats given epicutaneous doses, including controls, exhibited a marked decrease in bodyweight and weight gain during the treatment.
Maternal developmental toxicity
- Number of abortions:
- not specified
- Pre- and post-implantation loss:
- effects observed, treatment-related
- Description (incidence and severity):
- A slight, but statistically significant, lower average litter size was observed at 250 mg/kg bw/day and an increase in pre-implantation loss at 250 and 500 (Days 6-15) mg/kg bw/day. The animals given the highest epicutaneous dose exhibited higher reproduction as compared to controls (increased litter size and decreased post-implantation loss).
- Total litter losses by resorption:
- effects observed, treatment-related
- Description (incidence and severity):
- A slight, but statistically significant, lower average litter size was observed at 250 mg/kg bw/day and an increase in pre-implantation loss at 250 and 500 (Days 6-15) mg/kg bw/day. The animals given the highest epicutaneous dose exhibited higher reproduction as compared to controls (increased litter size and decreased post-implantation loss).
- Early or late resorptions:
- not examined
- Dead fetuses:
- not specified
- Changes in pregnancy duration:
- not specified
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): not specified - Changes in number of pregnant:
- not specified
- Other effects:
- not specified
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
The dams given 250 mg NPE-9/kg bw/day orally on Days 6-15 and 500 mg/kg bw/day on Days 6-15 and 1-20 exhibited a statistically significant decrease in weight gain. A concomitant decrease in food consumption was observed in dams exposed to 500 mg/kg bw/day as compared to controls. All rats given epicutaneous doses, including controls, exhibited a marked decrease in bodyweight and weight gain during the treatment.
Sporadic, not dose-related, changes in reproduction parameters were observed in the rats treated orally with NPE-9. A slight, but statistically significant, lower average litter size was observed at 250 mg/kg bw/day and an increase in pre-implantation loss at 250 and 500 (Days 6-15) mg/kg bw/day.
The animals given the highest epicutaneous dose exhibited higher reproduction as compared to controls (increased litter size and decreased post-implantation loss).
Effect levels (maternal animals)
- Dose descriptor:
- NOEL
- Effect level:
- 50 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
Maternal abnormalities
- Abnormalities:
- effects observed, treatment-related
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
In rats given NPE-9 orally, a statistically significant dose-related increase in extra ribs and rudiments of ribs was noted. In addition, an increased incidence in fetuses showing slightly dilated pelvic cavity was observed at 500 mg/kg bw/day (Day 1 - 20). When given epicutaneously, NPE-9 had no effects on skeletal and solt tissues. An increased incidence of extra ribs was seen at 50 mg/kg bw/day but not at 500 mg/kg bw/day (epicutaneous).
Effect levels (fetuses)
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 50 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Increase in extra ribs and rudiments of ribs, increased incidence in fetuses showing slightly dilated pelvic cavity (at 500 mg/kg bw/day)
- Remarks on result:
- other: following oral exposure
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 500 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No effects on skeletal and solt tissues
- Remarks on result:
- other: following epicutaneous exposure
Fetal abnormalities
open allclose all
- Key result
- Abnormalities:
- effects observed, non-treatment-related
- Localisation:
- other: skeletal: ribs and pelvic cavity
- Description (incidence and severity):
- Following oral exposure: Increase in extra ribs and rudiments of ribs, increased incidence in fetuses showing slightly dilated pelvic cavity (at 500 mg/kg bw/day)
- Key result
- Abnormalities:
- effects observed, non-treatment-related
- Localisation:
- skeletal: rib
- Description (incidence and severity):
- An increased incidence of extra ribs was seen at 50 mg/kg bw/day but not at 500 mg/kg bw/day (epicutaneous).
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Under the study conditions, the NOEL for NPE-9 was 50 mg/kg bw/day (Days 6 -15) when given orally. Higher doses exerted reproductive toxicity effects probably due to maternal toxicity. Epicutaneaius doses of NPE-9 had no effect.
- Executive summary:
Male and female Mol:WIST rats, 11 weeks of age, were mated. Mated females received NPE-9 (commercial formulation with an average ethoxylation grade of 9) by gavage (0, 50, 250 and 500 mg/kg bw/day) or skin application (0, 50 and 500 mg/kg bw/day) from Gestation Day 6 - 15 or 1 -20 (only 500 mg/kg bw/day per oral). Mated females were weighed on Days 1, 6, 9, 12, 15 and 21. On Day 21, the rats were sacrificed and necropsied. The following parameters were recorded: weight of the intact uterus and ovaries, number of corpora lutae, implantation and fetuses, live and dead. The fetuses were weighed, their sex determined and they were examined for gross external malformations. Half of the fetuses were examined for skeletal abnormalities. The remaining fetuses were fixed in Bouins solution and sectioned. Weight of dams, sex ration of fetuses and pre- and post-implantation losses were calculated.
The dams given 250 mg NPE-9/kg bw/day orally on Days 6-15 and 500 mg/kg bw/day on Days 6-15 and 1-20 exhibited a statistically significant decrease in weight gain. A concomitant decrease in food consumption was observed in dams exposed to 500 mg/kg bw/day as compared to controls. All rats given epicutaneous doses, including controls, exhibited a marked decrease in bodyweight and weight gain during the treatment. Sporadic, not dose-related, changes in reproduction parameters were observed in the rats treated orally with NPE-9. A slight, but statistically significant, lower average litter size was observed at 250 mg/kg bw/day and an increase in pre-implantation loss at 250 and 500 (Days 6-15) mg/kg bw/day. The animals given the highest epicutaneous dose exhibited higher reproduction as compared to controls (increased litter size and decreased post-implantation loss). In rats given NPE-9 orally, a statistically significant dose-related increase in extra ribs and rudiments of ribs was noted. In addition, an increased incidence in fetuses showing slightly dilated pelvic cavity was observed at 500 mg/kg bw/day (Day 1 - 20). When given epicutaneously, NPE-9 had no effects on skeletal and solt tissues. An increased incidence of extra ribs was seen at 50 mg/kg bw/day but not at 500 mg/kg bw/day (epicutaneous).
Under the study conditions, the NOEL for NPE-9 was 50 mg/kg bw/day (Days 6 -15) when given orally. Higher doses exerted reproductive toxicity effects probably due to maternal toxicity. Epicutaneous doses of NPE-9 had no effect (Meyer et al., 1988).
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