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EC number: 939-487-8 | CAS number: -
- 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:
- 22 January 1996 to 25 July 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- temperature 20-26°C and humidity 27-73% (19-25°C and 30-70% recommended), guideline recommends treatment until the day before caesarean section
- Principles of method if other than guideline:
- A developmental toxicity study to investigate the effects of oral gavage treatment during days 6 to 15 of gestation on pregnant rats and their foetuses, as evaluated on gestation day 20.
- GLP compliance:
- yes
- Limit test:
- no
Test material
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: deleted from report
- Age at study initiation: about 10-12 weeks
- Weight at study initiation: approximately 220 g
- Fasting period before study: no data
- Housing: singly in suspended polycarbonate cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): municipal water ad libitum
- Acclimation period: approximately 2 weeks (prior to mating)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 26
- Humidity (%): 27 to 73
- Air changes (per hr): minimum of 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 11 April 1996 To: 13-17 May 1996
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Dose formulations of 10, 100 and 200 mg/ml were prepared by weighing out an appropriate amount of Dow Corning(R) 556 Cosmetic Grade Fluid into a calibrated Erlenmeyer flask and bringing it to volume with corn oil. The formulations were heated until warm while stirring, with stirring continuing for at least half an hour. Solutions were prepared on 29 April and 6 May 1996, and stored at room temperature (with stirring prior to dispensation into dosing vials and during dosing).
VEHICLE
- Justification for use and choice of vehicle (if other than water): no data
- Concentration in vehicle: 10, 100 or 200 mg/ml
- Amount of vehicle (if gavage): 5 ml/kg bw
- Lot/batch no. (if required): no data
- Purity: no data - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Samples of the dosing formulations were sent to the Sponsor for confirmation of test material concentration. Stability and homogeneity were also determined by the Sponsor.
- Details on mating procedure:
- - Impregnation procedure: cohoused
- M/F ratio per cage: 1:1 or 1:2
- Length of cohabitation: no data
- Further matings after two unsuccessful attempts: no data
- Verification of same strain and source of both sexes: no data
- Proof of pregnancy: sperm in vaginal smear referred to as day 0 of pregnancy - Duration of treatment / exposure:
- 10 days (gestation days 6 through 15)
- Frequency of treatment:
- daily
- Duration of test:
- 15 days (untreated on days 0-5 of gestation, treated from days 6 to 15 of gestation, sacrifice at day 20 of gestation)
Doses / concentrationsopen allclose all
- Dose / conc.:
- 50 mg/kg bw/day
- Dose / conc.:
- 500 mg/kg bw/day
- Dose / conc.:
- 1 000 mg/kg bw/day
- No. of animals per sex per dose:
- 25 females
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: range-finding study
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily on weekdays and once daily on weekends for morbidity/mortality. Animals were observed for signs of toxicity once daily 0-3 hours after dose administration, and once daily on non-dosing days.
- No data on which specific cage side observations were performed
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: physical examinations on gestation days 0 and 20
BODY WEIGHT: Yes
- Time schedule for examinations: dams weighed on gestation days 0, 6, 11, 16 and 20
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes (gestation days 0-6, 6-11, 11-16 and 16-20)
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day #20
- Organs examined: uterus, ovaries, liver - Ovaries and uterine content:
- 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: all per litter
- Skeletal examinations: Yes: half per litter
- Head examinations: Yes: half per litter
See "Any other information on materials and methods incl. tables" for details on foetal examinations. - Statistics:
- Means and standard deviations were calculated for all measured parameters.
ANOVA (analysis of variance) was used to evaluate dam body weight, body weight gain, food consumption, uterus weight, liver weight, corrected body weight, corrected body weight gain, and foetal weight.
Analyses were performed using LABCAT (IPA, Inc. Princeton, N.J., version 4.64) for dam body weight, body weight gain, and food consumption; and Systat (SPSS, Inc., Chicago, IL, version 5.0) for uterus weight, liver weight, corrected body weight, corrected body weight gain, and foetal weights.
A one-factor ANOVA was used for viability data on corpora lutea, total implants, live implants, non-live implants (resorptions and deaths), the percent live implants, the percent non-live (resorptions and death) implants and percent preimplantation loss.
Dunnett's test was used for post-hoc comparisons between treatment and control groups in the presence of significant main effects.
Skeletal, visceral, cephalic, and gross external malformation data were statistically analysed by Chi-square or Fisher Exact tests when the incidence in the treated groups was higher than controls (i.e. difference in absolute number of affected fetuses of 3 or greater).
A minimum significance level of p ≤ 0.05 was used in the comparisons. - Indices:
- female:male ratio
- Historical control data:
- no data
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
No clinical signs of maternal toxicity were evident during the study, or were apparent from gross necropsy observations. Mean body weights, body weight gains, food consumption, uterus weights and liver weights showed no test article-related effects. No significant adverse findings were noted following Caesarean section (see table 1).
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: overall effects - no adverse effects on dams at any dose
Maternal abnormalities
- Abnormalities:
- no effects observed
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
Statistically significant increases in foetal body weights for the low dose group compared to vehicles for males (mean 4.29 vs 4.07 g) and combined sexes (mean 4.20 vs 3.99 g) were not considered biologically significant.
Visceral and skeletal abnormalities observed (see tables 2 and 3) were low in incidence, sporadic and not considered to be related to treatment as there was no dose response relationship, and a similar incidences of most of the abnormalities occurred in the control group.
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: overall effects - no adverse effects on foetuses at any dose
Fetal abnormalities
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Developmental effects observed:
- no
Any other information on results incl. tables
Table 1: Caesarean Section Observations
Observation |
Dose (mg/kg bw/day) |
|||
0 |
50 |
500 |
1000 |
|
# Animals Assigned (Mated) |
25 |
25 |
25 |
25 |
# Animals Pregnant Pregnancy Rate (%) |
23 92% |
22 88% |
22 88% |
23 92% |
Maternal Wastage # Died |
0 0 0 0 0 |
0 0 0 0 0 |
0 0 0 0 0 |
0 0 0 1 0 |
Total # Corpora Lutea |
312 (13.57 ± 2.61) |
247 (11.23 ± 3.07) |
267 (12.14 ± 3.56) |
267 (12.71 ± 1.76) |
Total # Implantations |
294 (12.78 ± 3.67) |
229 (10.41 ± 3.61) |
253 (11.5 ± 3.71) |
271 (11.78 ± 3.1) |
Total # Litters |
23 |
22 |
22 |
22 |
Total # Live Male Foetuses |
139 (6.04 ± 1.99) |
115 (5.23 ± 2.65) |
129 (5.86 ± 3) |
135 (6.14 ± 1.75) |
Total # Live Female Foetuses |
143 (6.22 ± 2.7) |
106 (4.82 ± 1.87) |
119 (5.41 ± 2.63) |
130 (5.91 ± 1.95) |
Total # Resorptions (Mean Resorptions/Dam) |
12 (0.52 ± 0.79) |
8 (0.36 ± 0.79) |
5 (0.23 ± 0.43) |
6 (0.26 ± 0.45) |
Sex Ratio (% Male) |
50% |
52% |
52% |
50% |
Preimplantation Loss (%) |
7.83 ± 17.71 |
8.84 ± 13.54 |
6.63 ± 11.94 |
4.13 ± 8.16 |
Table 2: Visceral Examinations
Observations+ |
Dose (mg/kg bw/day) |
|||
0 |
50 |
500 |
1000 |
|
#Fetuses (litters) examined |
282 (23) |
221 (22) |
248 (22) |
252 (21b) |
#Fetuses (litters) affected |
3 (3) |
3 (2) |
5 (2) |
7 (6) |
Hydroureter |
0 (0)a |
0 (0) |
1 (1) |
1 (1) |
Hydronephrosis |
0 (0) |
1 (1) |
0 (0) |
0 (0) |
Hyroureter/hydronephrosis Slight/mild Moderate/severe |
3 (3) 3 (3) 0 (0) |
2 (2) 3 (2) 0 (0) |
2 (2) 1 (1) 2 (2) |
4 (3) 5 (4) 0 (0) |
Heart, minor vessel defect |
0 (0) |
0 (0) |
4 (1) |
1 (1) |
Lung, lobe missing |
0 (0) |
0 (0) |
0 (0) |
1 (1) |
+Some observations may be grouped together
aFetal (litter) incidence
bData for all foetuses from one dam not included due to premature fixation in 70% ethanol
Table 3: Skeletal Examinations
Observations+ |
Dose (mg/kg bw/day) |
|||
0 |
50 |
500 |
1000 |
|
# Fetuses (litters) examined |
140 (23) |
110 (22) |
120 (22) |
134 (22) |
Sternebrae Any variation % Affected Malformations % Affected |
17 (9)a 12.1(39.1) 0 (0) 0 (0) |
8 (4) 7.3 (18.2) 0 (0) 0 (0) |
11 (8) 9.2 (36.4) 1 (1) 0.8 (4.5) |
3 (2) 2.2 (9.1) 0 (0) 0 (0) |
Centrae Any variation % Affected |
27 (13) 19.3(56.5) |
22 (13) 20 (59.1) |
31 (15) 25.8(68.2) |
22 (12) 16.4(54.5) |
Skull Any variation % Affected |
13 (6) 9.3 (26.1) |
10 (5) 9.1 (22.7) |
15 (8) 12.5(36.4) |
14 (6) 10.4(27.3) |
Body of Hyoid Any variation % Affected |
0 (0) 0 (0) |
0 (0) 0 (0) |
0 (0) 0 (0) |
0 (0) 0 (0) |
Ribs Wavy/bulbous 13th rib, any variation Rudimentary 14th Supernumary14th Cervical rib All rib abnormalities % Affected |
0 (0) 4 (2) 13 (7) 0 (0) 1 (1) 18 (9) 12.9 (39.1) |
2 (2) 0 (0) 7 (7) 0 (0) 6 (3) 15 (10) 13.6(45.5) |
1 (1) 0 (0) 8 (5) 0 (0) 3 (2) 10 (31.8) |
0 (0) 11 (5) 9 (6) 0 (0) 3 (3) 21 (12) 15.7(54.5) |
Pelvic girdle Pubis reduced % Affected |
1 (1) 0.7 (4.3) |
0 (0) 0 (0) |
0 (0) 0 (0) |
0 (0) 0 (0) |
Vertebral column Lumnar vertebrae Any variation % Affected Sacral vertebrae Incomplete ossification % Affected |
0 (0) 0 (0)
2 (2) 1.4 (8.7) |
0 (0) 0 (0)
1 (1) 0.9 (4.5) |
0 (0) 0 (0)
1 (1) 0.8 (4.5) |
0 (0) 0 (0)
0 (0) 0 (0) |
+Some observations may be grouped together
aFetal(litter)
incidence
Applicant's summary and conclusion
- Conclusions:
- In a developmental toxicity study, with a protocol similar to that decribed by OECD Test Guideline 414 and performed to GLP, no significant adverse effects were noted in the foetuses of pregnant rats treated orally with Dow Corning(R) 556 Cosmetic Grade Fluid at up to 1000 mg/kg bw/day from days 6 to 15 of gestation. Under the conditions of this study, the no-observed-adverse-effect level (NOAEL) for developmental toxicity and maternal toxicity was 1000 mg/kg bw/day (the highest dose tested).
- Executive summary:
In a GLP-compliant study, with a protocol similar to that described by OECD Test Guideline 414, Dow Corning Corporation® 556 Cosmetic Grade Fluid was tested for its potential developmental toxicity to Sprague-Dawley rats following oral administration.
Male and female rats were mated, with sperm-positive vaginal smears were taken as day 0 of gestation. Females were housed separately during gestation. Groups of 25 sperm-positive females were treated by daily gavage administration with the test material at 0, 50, 500 or 1000 mg/kg bw (in corn oil) on days 6 to 15 of gestation. Sacrifice and caesarean section took place on day 20 of gestation and a comprehensive range of developmental parameters were assessed. From each dam, the uterus and ovaries were removed and analysed and the liver was also removed and weighed. Foetuses were subject to necropsy to detect any gross macroscopic abnormalities.
All dams survived throughout the course of the study. Over the course of the study, there were no signs of maternal toxicity and gross necropsy of the dams did not reveal any significant adverse effects. Mean body weights, body weight gains, food consumption, uterus weights and liver weights showed no treatment-related effects. In the foetuses, there were no biologically significant differences in body weights. No statistically significant increases in foetal deaths, resorptions or malformations were observed in treatment-group foetuses relative to controls.
Under the conditions of this study, the no-observed-adverse-effect level (NOAEL) for developmental toxicity and maternal toxicity was 1000 mg/kg bw/day (the highest dose tested).
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