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EC number: 500-094-8 | CAS number: 37208-53-0 1 - 6.5 moles propoxylated
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February – March, 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Details on test material:
- Polyether V 579 supplied by Bayer material Sciences,
2,2',2''-Nitrilotriethanol, propoxylated.
average molecular weight (not specified in the report but provided by manufacturer in separate communication): 280 g/mol
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain: Hsd Cpb:WU
- Source: Harlan-Winkelmann GmbH, Borchen Germany
- Age at start of treatment: males: 11-12 weeks, females: 12-13 weeks
- Weight at study initiation: males: 321-348g; females: 181-206g
- Housing: individual
- Diet (e.g. ad libitum): ad libitum(Provimi Kliba maintenance Diet)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 13 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1°C
- Humidity (%): 50
- Air changes (per hr): ≥ 10 passages/hour
- Photoperiod (hrs dark / hrs light): 12 hours rhythm
IN-LIFE DATES: From: January 31st to May 10, 2005
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- Amount of vehicle (if gavage): 10 ml/kg bw
- Details on mating procedure:
- MATING PROCEDURES: Pairing was performed overnight by placing one F0 female animal together with one F0 male rat. If sperm was detected in the vaginal smear taken on the morning following mating, this day was regarded as day 0 of gestation. Animals were paired daily during the 2-week mating and one week remating period. Females in which insemination had not been detected by the end of the 2-week mating period, were mated for another week with another male of the respective dose group which had successfully inseminated a female paired with it. F0 females found sperm-positive after the first matings but where body weight gain did not indicate pregnancy by the end of the 2-week mating period were paired again for 7 days during the remating period.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Liquid chromatography.
- Frequency of treatment:
- Daily
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0
Basis:
nominal in water
- Remarks:
- Doses / Concentrations:
100
Basis:
nominal in water
- Remarks:
- Doses / Concentrations:
300
Basis:
nominal in water
- Remarks:
- Doses / Concentrations:
1000
Basis:
nominal in water
- No. of animals per sex per dose:
- 12 animals per sex per dose
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Doses were selected according to a preceding subacute rat study were the same doses were applied over 4 weeks by gavage.
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: The experimental animals were inspected twice a day for morbidity and mortality (once on weekends and public holidays). General clinical examinations (in the home cage) were made daily (especially findings occurring during littering e.g. prolonged parturition) some time (about 30 to 60 minutes) after the administration and recorded, if any.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: F0-Males: Prior to the treatment and then weekly up to necropsy.
F0-Females: Prior to the treatment and then weekly during premating and mating
period. Additionally, during pregnancy and lactation period daily.
BODY WEIGHT: Yes
- Time schedule for examinations: The individual body weights of all parental animals were determined just prior before the first treatment of animals and then daily thereafter.
FOOD CONSUMPTION: Yes
- Time schedule for examinations: The food intake of F0 males was measured weekly during the premating period on a seven day basis.
In F0 females food intake was measured in the same way during the premating period. During gestation period determination of food intake was done on post-coital days 0-7, 7-14 and 14-20. During lactation period determination of food intake was done on day 0-4 p.p.
WATER CONSUMPTION : No - Litter observations:
- -The numbers of live and dead pups as well as the sex of the pups (including those of dead pups, if possible) were determined shortly after birth (on postpartum day 0) and on day 4 p.p. At these time points individual body weights and clinical signs were recorded as well. Note was taken of any apparent malformations.
- Postmortem examinations (parental animals):
- Gross pathological examination:
- Gross pathological examination was performed for all females and males at necrosy. In F0 females the number of implantation sites was counted and the number of corpora lutea was determined.
HISTOPATHOLOGY / ORGAN WEIGHTS
- Organ weights: testes, epididymides,
- Abnormalities and the following organs were preserved: testes, epididymides, prostate, seminal vesicles with coagulating glands, uterus with vagina, ovaries with oviducts.
Histopathological examination of reproductive organs (testes, epididymides, ovaries) from control and 1000 mg/kg (highest dose) group. - Statistics:
- Analysis of Variance (ANOVA) and in case of significant results Dunnett test as post hoc test 2*N CHi2 test; in case of significant differences Fisher's exact test with Bonferroni correction CHi2 test and Fisher’s Exact test.
- Reproductive indices:
- Reproductive indices:
- mating performance
- insemination index
- fertility index
- gestation index
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Other effects:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- no effects observed
Details on results (P0)
Gross pathology: Findings in one animal found in moribund condition an immediately sacrificed - not considered test material related.
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOEL
- Effect level:
- 300 mg/kg bw/day (nominal)
- Sex:
- male
- Basis for effect level:
- other: based on salivation - as concluded in the report.
- Dose descriptor:
- NOEL
- Effect level:
- 100 mg/kg bw/day (nominal)
- Sex:
- female
- Basis for effect level:
- other: based on salivation - as concluded in the report.
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
- Dose descriptor:
- NOAEL
- Effect level:
- 300 mg/kg bw (total dose)
- Sex:
- female
- Basis for effect level:
- other: NOAEL as concluded in the report based on general toxicity (loss of body weight during lactation) as a potential relation to dosing could not be ruled out by the author.
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day
- Sex:
- male
- Basis for effect level:
- other: NOAEL as concluded in the report. No adverse effects observed with males in the Study.
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Histopathological findings:
- not examined
Details on results (F1)
Sex ratio in F1: not affected by treatment.
Not considered test material related. Other singular findings all not considered treatment related.
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The registrant considers the mild bodyweight loss observed with females at the highest dose group (1000 mg/kg bw/day) as non adverse treatment related effect as it follows a statistically significant increased body weight gain, as compared to control, in the premating phase.
The No Adverse Effect Level is therefore concluded to be >=1000 mg/kg bw/day.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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