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EC number: 203-197-3 | CAS number: 104-38-1
- 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:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 2,2'-p-phenylenedioxydiethanol
- EC Number:
- 203-197-3
- EC Name:
- 2,2'-p-phenylenedioxydiethanol
- Cas Number:
- 104-38-1
- Molecular formula:
- C10H14O4
- IUPAC Name:
- 2,2'-[1,4-phenylenebis(oxy)]diethanol
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Analysis of dosing formulations was undertaken with regard to concentration and homogeniety on Weeks 1,3 and 6 of the study.
- Duration of treatment / exposure:
- The males were treated for 2 weeks prior to mating, through mating and until necropsy after 4 weeks of treatment.
The females were treated for 2 weeks prior to mating, throughout mating, gestation and until termination on ca. Day 4 of lactation. - Frequency of treatment:
- Once daily, 7 days per week
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
100 mg/kg
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
300 mg/kg
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
1000 mg/kg
Basis:
actual ingested
- No. of animals per sex per dose:
- 10 males and 10 females
- Control animals:
- yes, concurrent vehicle
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Twice daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Weekly
BODY WEIGHT: Yes
- Time schedule for examinations: Daily, commencing one week prior to treatment until termination
FOOD CONSUMPTION: Yes
- Time schedule: Weekly
WATER CONSUMPTION: Yes
- Time schedule: Weekly - Litter observations:
- PARAMETERS EXAMINED
The following parameters were examined in offspring: the number of live pups and number found dead were recorded as soon as possible after completion of parturition. The live pups were sexed, counted, examined for the precense of milk in the stomach and for any externally visible abnormalities daily until Day 4 of lactation. - Postmortem examinations (parental animals):
- GROSS NECROPSY: the cranial, thoracic and abdominal contents were examined macroscopically
ORGAN WEIGHTS: For males the testes and epididymides.
HISTOPATHOLOGY: For males each of the testes and epididymides. For females each of the ovaries.
Both for top dose and control animals only. - Statistics:
- Body weight and food comsumption data were subjected to analysis of variance or the Kruskal-Wallis non-parametric analysis as appropriate.
Organ weight data were analysed by analysis of variance and analysis of covariance.
Histology data were analysed by Fischers Exact Probability test - Reproductive indices:
- The following fertility indices were evaluated for each group: Fertility index (male), Fertility index (female), Gestation Index.
- Offspring viability indices:
- The following fertility indices were evaluated for each group: Birth Index, Live Birth Index, Viability Index
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
Reproductive function / performance (P0)
- Reproductive performance:
- no effects observed
Effect levels (P0)
- Dose descriptor:
- NOEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Absence of treatment-related effects
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
Effect levels (F1)
- Dose descriptor:
- NOEL
- Generation:
- F1
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Absence of treatment-related effects
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- There were no obvious effects on parental toxicity, nor were there any obvious effects of treatment on fertility, pregnancy performance or pup development. The NOEL was 1000 mg/kg for both adults and pups.
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