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EC number: 500-234-8 | CAS number: 68891-38-3 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
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- Flash point
- Auto flammability
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- Endpoint summary
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- Environmental data
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- 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
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- Toxicological Summary
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- Acute Toxicity
- Irritation / corrosion
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- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
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- Additional toxicological data

Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 8 June - 15 July 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- Administration comprised only period of organogenesis.
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Alcohols, C12-14, ethoxylated, sulfates, sodium salts
- EC Number:
- 500-234-8
- EC Name:
- Alcohols, C12-14, ethoxylated, sulfates, sodium salts
- Cas Number:
- 68891-38-3
- Molecular formula:
- not applicable, UVCB
- IUPAC Name:
- Alcohols, C12-14(even numbered), ethoxylated < 2.5 EO, sulfates, sodium salts
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- CD
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Wiga Sulzfeld, Germany
- Age at study initiation: 7 - 8 weeks
- Weight at study initiation: approx. 204 g
- Number of animals: 96, primiparous time-mated females
- Housing: Individually in Makrolon Type M3 cage (Ebeco, 44579 Castrop-Rauxel, Germany) with standard softwood bedding (ARWI-Center, 45307 Essen, Germany)
- Diet: Pelleted Altromin Maintenance Diet 1324, ad libitum
- Water: Community tap water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 23
- Humidity (%): 42 - 66
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 8 June 1993 To: 15 July 1993
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
Dosing solutions were prepared daily by dissolving appropriate amounts of the test material in water yielding a final concentration of 1, 3, and 10% corresponding to 100, 300 and 1000 mg/kg bw/day, respectively.
VEHICLE:
- Concentration in vehicle: 1, 3 and 10%
- Amount of vehicle: 10 mL/kg bw - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The formulation was analysed by "Henkel TTA-Zentrale Analytik" in the time from 21 - 30 June 1993 (study number TTA 93-6431). The concentrations of the test substance in aqua dest. based upon the results of the determination of the dry sediment confirmed the active content of 70.1% of the test substance.
- Details on mating procedure:
- - Impregnation procedure: purchased timed pregnant
The females were mated at the supplier with an accurate day of mating. They were received at the testing facility on day 0 of gestation.
The mated animals (number) were delivered:
June 08, 1993 (24)*
June 09, 1993 (24)
June 23, 1993 (24)
June 24, 1993 (18)
June 25, 1993 (16)**
*: on delivery 3 animals dead, 1 animal died one day later
**: 15 females used in study - Duration of treatment / exposure:
- Day 6-15 (incl.), post coitum
- Frequency of treatment:
- daily, 7 days/week
- Duration of test:
- Until Day 20 post coitum
Doses / concentrationsopen allclose all
- Dose / conc.:
- 100 mg/kg bw/day (actual dose received)
- Remarks:
- corrected for a.i. content of test material
- Dose / conc.:
- 300 mg/kg bw/day (actual dose received)
- Remarks:
- corrected for a.i. content of test material
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- Remarks:
- corrected for a.i. content of test material
- No. of animals per sex per dose:
- 24 females
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale:
The dose selection is based on the results of an earlier toxicoligical investigation. Rats (10 animals/dose/sex) were orally exposed to 100, 500 and 1000 mg/kg bw/day for 28 days (BASF, 1985, TBD870334). Adverse effects (lesions in the mucosa of the forestomach) were observed at 500 and 1000 mg/kg bw/day. In addition, alterations in hematology and clinical chemistry parameters were observed in the mid- and high-dose group animals when compared to the controls. Therefore, 100, 300 and 1000 mg/kg bw/day were selected as the dose levels for the pre-natal developmental toxicity study since the females in this study were dosed on only 10 consecutive days (Day 6 - 15, inclsive, post coitum).
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS AND MORTALITY: Yes
- Time schedule: twice daily
- Cage side observations included: mortality, signs of reaction to treatment and symptoms of illness
DETAILED CLINICAL OBSERVATIONS: No
BODY WEIGHT: Yes
- Time schedule for examinations: Days 0, 6, 16 and 20 post coitum
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on Day 20 post coitum by an overdose of ether
- Organs examined: all maternal organs - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included: Gravid uterus weight, number of corpora lutea, implantations and early/late resorptions
The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes - Fetal examinations:
- - External examinations: Yes, all per litter
- Soft tissue examinations: Yes, half per litter
- Skeletal examinations: Yes, half per litter
- Head examinations: No - Statistics:
- If the variables could be assumed to follow a normal distribution, the Dunnett-Test, based on a pooled variance, was applied for the comparison between the treated groups and the control group.
The Steel-Test was applied when the data could not be assumed to follow a normal distribution.
Fisher's Exact test for 2x2 tables was applied if the variables could be dichotomised without loss of information (Bonferroni-Holm-corrected).
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No test substance-related symptoms were observed in any animal at any dose level.
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- no mortality observed
- Description (incidence):
- No deaths occured in any dams of the control and treatment groups.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- Body weights and body weight gains were essentially similar in all groups and comparable with the controls.
- Food consumption and compound intake (if feeding study):
- not examined
- 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:
- no effects observed
- Description (incidence and severity):
- No macroscopic changes were noted in the dams of the control and treatment groups.
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- effects observed, non-treatment-related
- Description (incidence and severity):
- In the mid-dose group (300 mg/kg bw/day), the mean value of the pre-implantation loss was decreased (level 5%). The finding was considered incidental and in the normal range.
- Total litter losses by resorption:
- no effects observed
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- no effects observed
- Changes in number of pregnant:
- no effects observed
- Other effects:
- no effects observed
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day (actual dose received)
- Based on:
- act. ingr.
- Remarks:
- corrected for a.i. content of test material
- Basis for effect level:
- other: No treatment-related effects observed.
Maternal abnormalities
- Key result
- Abnormalities:
- no effects observed
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Reduction in number of live offspring:
- effects observed, non-treatment-related
- Description (incidence and severity):
- In the high-dose group (1000 mg/kg bw/day), the mean value of the total males was increased (level 5%) and that of the total females decreased (level 5%). These findings were considered to be incidental and in the normal range.
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- no effects observed
- Changes in postnatal survival:
- not examined
- External malformations:
- no effects observed
- Skeletal malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The statistically significant differences were considered to be incidental. The finding "two sternebrae, non ossified" is not a negative effect of the substance because a decrease indicate a more developed embryonic stage than in the other fetuses. The retardation effect of the "hyoid, incomplete ossified" is also incidental and not dose-related. Only singular litters were affected. The incidental character of this variation is emphasised by the fact the values were within the normal range of variation of this strain.
- Visceral malformations:
- no effects observed
- Other effects:
- no effects observed
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day (actual dose received)
- Based on:
- act. ingr.
- Remarks:
- corrected for a.i. content of test material
- Sex:
- male/female
- Basis for effect level:
- other: No treatment-related effects observed.
Fetal abnormalities
- Key result
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- The results of this study showed that repeated oral administration (Day 6-15 post coitum) of the test substance to pregnant rats caused no symptoms of cumulative toxicity and does not reveal any embryotoxic or teratogenic potential up to a dose level of 1000 mg/kg body weight/day.
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