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EC number: 500-046-6 | CAS number: 26183-52-8 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
- Study period:
- 14 JUN 1982 - 22 JUL 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD 416
- Deviations:
- yes
- Remarks:
- Only 3 applications per week; no or only partial examination of oestrous cycle and spermatogenicity performed, no analytical purity reported
- Principles of method if other than guideline:
- The study was conducted similar to OECD TG 416 (2-generation reproductive toxicity study). Therefore, no continous exposure with the test material was performed during gestation. No fetal examinations are available since pups were used for further mating to produce F2 generation.
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Reference substance 001
- EC Number:
- 614-482-0
- Cas Number:
- 68439-46-3
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Portage, Michigan, USA
- Age at study initiation: (P) 6 - 7 weeks; (F1) 4 - 7 weeks
- Weight at study initiation: (P) Males: 119.5 - 142.8 g; Females: 104.4 - 137.4 g; (F1) Males: 57.2 - 162.1 g; Females: 52.8 - 112.7 g
- Housing: animals were housed individually in wire-mesh bottom, polycarbonate cages
- Use of restrainers for preventing ingestion: no data
- Diet: Purina Formulab Chow (#5008), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 19 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): 40 - 65
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 14 Jun 1982 To: 22 Jul 1983
Administration / exposure
- Route of administration:
- dermal
- Vehicle:
- water
- Details on exposure:
- TEST SITE
- Area of exposure: The test material was applied on the back of each animal.
- Time intervals for shavings or clippings: The back hair was shaved each week prior to initial weekly application and when necessary throughout the week to ensure adequate dermal exposure.
TEST MATERIAL
- Amount(s) applied: 1 mL/kg bw
- Concentration (if solution): 1, 10 and 25% (w/v)
- Constant volume or concentration used: yes
VEHICLE
- Amount(s) applied: 1 mL/kg bw
USE OF RESTRAINERS FOR PREVENTING INGESTION: no data - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Since dosing solutions were analysed by a combination of high performance liquid chromatographic method and gas chromatographic method, and were stable for at least 7 weeks, separate batches of dosing solutions were prepared approximately every four weeks. Rats were treated with a new batch of the appropriate dosing solution within 7 weeks. Each dosing solution was analysed prior to its use for verification of the test material´s concentration. The maximum observed deviation from the nominal concentration was 10%.
- Details on mating procedure:
- - M/F ratio per cage: 1/1
- Length of cohabitation: up to 3 weeks
- Proof of pregnancy: vaginal plug / sperm in vaginal smear referred to as day 0 of pregnancy
- After successful mating each pregnant female was caged (how): individually in a polycarbonate cage with Absorb-dri (nestwood chips) as nesting material - Duration of treatment / exposure:
- (P) Males: 102 days before mating.
(P) Females: 170 days from the initiation of the study until the F1 generation was weaned
(F1) Males: 123 days at weaning, during growth into adulthood, mating and production of an F2 generation
(F1) Females: 221 days at weaning, during growth into adulthood, mating and production of an F2 generation, 30 days after the last litter was weaned - Frequency of treatment:
- 3/week (except during mating)
- Duration of test:
- Day 0 of Gestation until weaning
Doses / concentrationsopen allclose all
- Dose / conc.:
- 10 mg/kg bw/day
- Remarks:
- nominal in water, corresponding to 1% (w/v)
- Dose / conc.:
- 100 mg/kg bw/day
- Remarks:
- nominal in water, corresponding to 10% (w/v)
- Dose / conc.:
- 250 mg/kg bw/day
- Remarks:
- nominal in water, corresponding to 25% (w/v)
- No. of animals per sex per dose:
- 30 P males, 30 P females
20 F1 males, 40 F1 females - Control animals:
- yes, concurrent vehicle
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Observations were made once daily during treatment and mating periods for morbidity, mortality, general physical appearance, and clinical signs of toxicity. During gestation and lactation periods rats were observed in the morning and afternoon.
DETAILED CLINICAL OBSERVATIONS: No
BODY WEIGHT: Yes
- Time schedule for examinations: Male and female body weights were taken weekly up to the time of mating. Females were weighed on days 0, 7, 14, and 20 of gestation and on days 1, 4, 7, 21 and 28 of lactation. Pups were weighed as a litter on days 1, 4, 7, 21 and 28 of lactation, and were also weighed individually on day 28 of lactation.
FOOD CONSUMPTION AND COMPOUND INTAKE: No
WATER CONSUMPTION AND COMPOUND INTAKE: No - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: No
- Fetal examinations:
- - External examinations: No
- Soft tissue examinations: No
- Skeletal examinations: No
- Head examinations: No - Statistics:
- Organ weight, organ weight/body weight ratio, LDH-X enzyme activity and litter size, sex ratio, survival index and gestational length were analysed by analysis of variance. Treatment groups were compared to the control group by one-tailed Dunnett´s t-test at p=0.05. Body weights were analysed by analysis of covariance. Body weights in all dose groups were adjusted for body weight on the first day of dosing due to differences in initial weights among the treatment groups. Gestational weights were adjusted to the common body weight on gestational day 0, and lactational weights were adjusted to that on lactational day 1. Pup weights and number of live and dead pups were adjusted for the differences in litter size among all dose groups. The analysis of covariance was used to adjust the treatment means for the differences in the covariates among the treatment groups. Subsequent treatment comparisons against the control were then made on the adjusted treatment means. The adjusted treatment means represent the means of the treatment groups if they were to have the same mean value in the covariate. Fertility indices were analysed by one-tailed Fisher´s exact test. Mating indices were analysed by Chi-square with continuity correction. Sperm counts and survival indices were analysed by non-parametric method, Kruskal-Wallis test. Treatment groups were compared to the control by one tailed Dunnett´s t-test at p=0.05 on the ranked data.
- Indices:
- Mating Index (%) = (No. of females mated / No. of females housed with males) x 100
Fertility Index (%) = (No. of females pregnant / No. of females mated) x 100
Survival Index (%) = (pups alive at day 1 / total born pups) x 100
Lactation Index (%) = (pups alive at day 28 / pups alive day 4 after culling) x 100 - Historical control data:
- no data
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes. Remark: non-adverse
Details on maternal toxic effects:
In the F0 adults, body weights of the 1% and 10% dose groups were not affected by the treatment. However, significantly lower (p<0.05) body weights of the 25% dose group were observed during certain intervals when compared to the control. There were statistically significantly lower body weights in the 25% dose group males between days 35-105 during the dosing period; in females, body weights were only significantly lower at day 49, but were slightly lower than the control during the rest of the dosing period. In the F1 adults, body weights of the 1% and 10% dose groups were not affected by the treatment when compared to the control group. However, body weights of the 25% dose group males were lower but only statistically significant (p<0.5) at days 21, 28 and 35 during the dosing period; body weights of the 25% dose group females were lower from days 14-119 during the dosing period when compared to the controls. There were no compound-related effects on maternal body weights of all dose groups during the gestational and lactational periods in the F0 and F1 generations when compared to the controls. On lactational day 14, maternal body weights of the 1%, 10% and 25% dose groups were statistically significantly higher than the control. These increases were of no toxicological significance. In the F1 adult females, significantly higher absolute and relative weights of liver, heart and kidney and the relative lung weight of the 25% dose group, higher absolute and relative heart weights and relative liver weights of the 10% dose group were noted.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOEL
- Remarks:
- maternal
- Effect level:
- 100 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Remarks:
- corresponding to 10% (w/v)
- Basis for effect level:
- other: No treatment-related effects observed.
- Dose descriptor:
- NOAEL
- Remarks:
- maternal
- Effect level:
- >= 250 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Remarks:
- corresponding to 25% (w/v)
- Basis for effect level:
- other: Changes in body weight and organ weights without associated pathological findings.
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes. Remark: non-adverse
Details on embryotoxic / teratogenic effects:
Two pups, one male from a litter of the F1 10% dose group and one female from another litter of the F2 25% dose group were found dead, and they appeared to have been dehydrated. No pathologic finding was noted in these pups. One female pup (F2 1% dose group) in a litter was born with a short right forelimb and the left hindlimb and was reported missing on day 4 postnatally. Presumably it was canabalised by its mother. Another female pup in a litter (F2 25% dose group) was born dead with a short forelimb and small eyes. The left ocular zone contained a small piece of ocular tissue, the optic cup without a lens; the right eye was smaller than usual. The low incidence of these findings in rats is apparently due to spontaneous occurrence of developmental anomalies. There was no compound related effect on the pup weights of any dose group in either the F1 or F2 generations when compared to the controls. There was no compound-related effect on the development of the pups. All observed effects were considered to be non-adverse.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Remarks:
- developmental
- Effect level:
- >= 250 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Remarks:
- corresponding to 25% (w/v)
- Sex:
- male/female
- Basis for effect level:
- other: No treatment-related effects observed.
Fetal abnormalities
- Abnormalities:
- effects observed, non-treatment-related
- Localisation:
- external: eye
- external: limb
Overall developmental toxicity
- Developmental effects observed:
- yes
- Lowest effective dose / conc.:
- 100 mg/kg bw/day (nominal)
- Treatment related:
- no
- Relation to maternal toxicity:
- developmental effects in the absence of maternal toxicity effects
- Dose response relationship:
- no
- Relevant for humans:
- no
Any other information on results incl. tables
Table 1: Mean litter size, mean number of live pups and sex ratios of F1 and F2 pups during lactation
Dose concentration in % (w/v) |
0 |
1 |
10 |
25 |
F1 pups |
||||
Day 0 - Litter size |
8.2 |
9.6 |
7.9 |
6.4 |
Day 0 Dead pups |
0.0 |
0.1 |
0.1 |
0.1 |
Day 0 Live pups |
8.2 |
9.5 |
7.8 |
6.3 |
Day 1 Live pups |
8.2 |
9.4 |
7.7 |
6.3 |
Day 4 Live pups |
8.2 |
9.4 |
7.7 |
6.3 |
Day 7 (a) Live pups |
7.6 |
8.6 |
7.0 |
5.9 |
Day 14 Live pups |
7.6 |
8.6 |
7.0 |
5.9 |
Day 21 Live pups |
7.6 |
8.6 |
6.9 |
5.9 |
Day 28 Live pups |
7.6 |
8.6 |
6.9 |
5.9 |
Sex ratio of pups % males/%females |
46/54 |
40/60 |
47/53 |
45/55 |
F2 pups |
||||
Day 0 - Litter size |
6.9 |
8.3 |
8.0 |
8.4 |
Day 0 Dead pups |
0.1 |
0.0 |
0.0 |
0.1 |
Day 0 Live pups |
6.8 |
8.3 |
8.0 |
8.3 |
Day 1 Live pups |
6.7 |
8.3 |
7.9 |
8.2 |
Day 4 Live pups |
6.7 |
8.2 |
7.9 |
8.1 |
Day 7 (a) Live pups |
6.7 |
7.9 (b) |
7.6 (b) |
7.8 |
Day 14 Live pups |
6.7 |
8.1 (b) |
7.6 |
7.6 |
Day 21 Live pups |
6.6 |
8.0 |
7.6 |
7.6 |
Day 28 Live pups |
6.6 |
8.0 |
7.4 |
7.6 |
Sex ratio of pups % males/%females |
46/54 |
44/56 |
52/48 |
50/50 |
(a): after culling
(b): one litter was excluded from the calculation because the number of live pups were not counted
Table 2: Mean pup body weights (adjusted for litter size) for F1 and F2 pups (a)
Dose concentration in % (w/v) |
0 |
1 |
10 |
25 |
Body weights (g) F1 pups |
||||
Day 1 |
5.40 |
5.43 |
5.41 |
5.62 |
Day 4 |
8.10 |
7.77 |
7.93 |
8.56 |
Day 7 |
11.75 |
11.64 |
11.30 |
12.35 |
Day 14 |
21.42 |
21.20 |
22.30 |
22.48 |
Day 21 |
33.72 |
33.67 |
32.36 |
35.33 |
Day 28 |
59.06 |
59.13 |
58.53 |
60.62 |
Body weights (g) F2 pups |
||||
Day 1 |
5.56 |
5.65 |
5.66 |
5.74 |
Day 4 |
8.18 |
8.50 |
8.68 |
8.70 |
Day 7 |
12.07 |
12.21 |
12.53 |
12.70 |
Day 14 |
20.47 |
21.24 |
21.52 |
21.67 |
Day 21 |
30.77 |
31.80 |
32.78* |
32.32 |
Day 28 |
55.89 |
57.76 |
59.34 |
57.81 |
(a): mean pups were calculated from litter weights divided by number of pups per litter
*: significantly different from the control group by using a one-tailed Dunnett´s t-test at p≤0.05
Applicant's summary and conclusion
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.
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