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EC number: 701-410-9 | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997-04-14 to 1997-05-01
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4900 (Prenatal Developmental Toxicity Study)
- Version / remarks:
- (Similar to OECD 414)
- GLP compliance:
- yes
- Limit test:
- no
Test material
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Charles River Crl:CD VAF/Plus
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Labs, Portage, MI, USA
- Age at study initiation: not stated
- Weight at study initiation: 235-240 g (day 0 of study)
- Housing: 1/suspended stainless steel cage
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: 10 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 72-75 deg F
- Humidity (%): 44-56
- Photoperiod (hrs dark / hrs light): 12 h/12 h
IN-LIFE DATES: From: 1997-04-14 To: 1997-04-28
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- peanut oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: 0.3, 1.5 or 9 g of TS were added to 30 ml vehicle (peanut oil), mixed with magnetic stir bar. Solution said to be stable for 12 h; prepared daily. A constant volume of 2 ml/kg bw of these solutions or the vehicle were administered daily. No tests were conducted on the on homogeneity or stability of prepared solutions.
DIET PREPARATION
no details given
VEHICLE
- Justification for use and choice of vehicle (if other than water): None given (TS hydrolyses in water)
- Concentration in vehicle: 0.3, 1.5 or 9 g of TS in 30 ml vehicle
- Amount of vehicle (if gavage): 2 ml/kg bw
- Lot/batch no.: Sigma Peanut Oil (P-2144); lot 83H0848
- Purity: not stated - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- doses: 20, 100 and 600 mg/kg bw/day
target concentrations: 10, 50, 300 mg/ml
measured average concentration: 9.34, 51.2, 299 mg/ml - Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 1:1
- Length of cohabitation: until copulatory plug or vaginal smear was present.
- Proof of pregnancy: copulatory plug or vaginal smear confirmed mating - Duration of treatment / exposure:
- Day 6 of gestation to day 17 of gestation [NB the SIAR (2003) report of this study notes treatment from GD 6 to 20]
- Frequency of treatment:
- once per day
- Duration of test:
- Observations from gestation day (GD) 6 to GD 20.
- No. of animals per sex per dose:
- 30 females
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Sex: female
Duration of test: Through day 20 of gestation
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily GD 6-20
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: GDs 0, 6, 9, 12, 15, 18, 20
FOOD CONSUMPTION : Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg bw/day: Yes. determined on GDs 0, 6, 9, 12, 15, 18, 20
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on GD 20
- Organs examined: laparaohysterectomic examination and necropsy
- Ovaries and uterine content:
- The ovaries and uterine content were 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 of the fetuses from 0 and 600 mg/kg bw /day groups
- Skeletal examinations: Yes: half per litter from all dose groups
- Head examinations: yes
Other: weight and sex determination - Statistics:
- One-way analysis of variance (ANOVA) was used to analyze mean maternal gestation body weights, body weight changes, and food consumption, mean number of corpora lutea, implantation sites, live foetuses(male and female), postimplantation losses, resorptions (early and late), mean fetal weights (male and female), gravid uterine weights, carcass weights, and net weight change from day 0. If the ANOVA was significant, pairwise comparisons to the vehicle control were performed using Dunnett's test. Pairwise comparison with vehicle control (Dunnet, 1964) if ANOVA significant.
A Kruskal-Wallis test was used to analyze mean percent preimplantation losses and live fetuses (male and female) per animal, mean percent postimplantation losses, dead fetuses, and resorptions (early and late) expressed as percentages of implantations per animal, mean percent affected fetuses per litter for external, visceral, and skeletal malformations and developmental variations, and mean percent affected fetuses per liter for external, visceral, and skeletal malformations and developmental variations. If the Kruskal-Wallis test was significant, pairwise comparisons to the vehicle control were made using a Mann-Whitney U test.
A Pearson chi-square test was used to analyze fetal and litter incidence of fetal external, visceral and skeletal malformations and developmental variations, as well as litter incidence of total fetal external, visceral and skeletal malformations and developmental variations. If the chi-square test was significant, pairwise comparisons to the vehicle control were performed using a Fischer's exact test. - Indices:
- No data given as indices (see REMARKS ON RESULTS INCLUDING TABLES AND FIGURES for details of reproductive/developmental findings).
- Historical control data:
- Full historical control data given (Charles River CD).
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Clinical signs although not restricted to the animals that died, were predominantly observed in these animals exposed to 600 mg/kg/day and included hypoactivity, cold to the touch, body surface stained and material around the mouth and nose. Additionally, respiratory signs including laboured breathing, gasping and rales in the 600 mg/kg/day dose group. No signs were observed in the two lower dose (100 and 20 mg/kg bw/day) groups.
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- At 600 mg/kg bw/day, 5/30 deaths occurred. Furthermore, 2 rats were found dead on gestation day 7, one rat died on gestation days 13, 15 and 17 respectively.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- At 600 mg/kg/day, a slight decrease (not statistically significant) in the body weight gain was observed during gestation days 6 to 9. Since this decrease was consistent with significant decreases in the food consumption, it was considered to be treatment-related observations. No other significant treatment-related effects on the body weight gain were observed at any dose level.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- At 600 mg/kg/day dose level, a statistically significant decrease occurred in the food consumption during gestation days 6 to 9.
A statistically significant decrease in the food consumption were observed at gestation day 19 to 20 at 100 mg/kg/day. However, since no effect was observed at the 600 mg/kg/day dose level in the latter incidence, it was considered to be not treatment-related. No other significant treatment-related effects on the food consumption were observed at any dose level during the treatment period. - Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- not specified
Maternal developmental toxicity
- Number of abortions:
- not specified
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- no effects observed
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- not specified
- Changes in number of pregnant:
- no effects observed
- Other effects:
- no effects observed
- Description (incidence and severity):
- A statistically significant increase in the mean number of corpora lutea was observed at 600 mg/kg/day, however, it was considered to not be treatment related as ovulation and corpora lutea formation occurred prior to exposure to the test article.
Effect levels (maternal animals)
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- 600 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- 600 mg/kg bw/day
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- no effects observed
- Changes in postnatal survival:
- not specified
- External malformations:
- no effects observed
- Skeletal malformations:
- effects observed, treatment-related
- Description (incidence and severity):
- At 600 mg/kg/day, statistically significant increases in the incidences of the variations 27 presacral vertebrae and sternebrae unossified were observed.
- Visceral malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- At 100 mg/kg/day, a statistically significant increase in the incidence of the variation extra pair of full ribs was observed, however, since no effects were observed at the 600 mg/kg/day, it was considered to not be treatment-related indices.
- Other effects:
- not specified
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- effects observed, treatment-related
- Localisation:
- skeletal: sternum
- skeletal: vertebra
- Description (incidence and severity):
- At 600 mg/kg/day, statistically significant increases in the incidences of the variations 27 presacral vertebrae and sternebrae unossified were observed
Overall developmental toxicity
- Developmental effects observed:
- yes
- Lowest effective dose / conc.:
- 600 mg/kg bw/day
- Treatment related:
- yes
- Relation to maternal toxicity:
- not specified
- Dose response relationship:
- yes
- Relevant for humans:
- not specified
Any other information on results incl. tables
Mortality and day of death:
Dose (mg/kg bw/day) No. Dead Day of Death (gestation day)
0 0/30 -
20 0/30 -
100 0/30 -
600 5/30 7,7,13,15,17
Number pregnant per dose level:
Dose (mg/kg bw/day) No. Pregnant
0 29/30
20 25/30
100 26/30
600 22/30
Number aborting: none
Number of resorptions:
Dose (mg/kg bw/day) No. Resorptions (early + late)
0 34
20 25
100 38
500 25
Number of implantations:
Dose (mg/kg
bw/day) No. Implantations
0 437
20 368
100 361
600 358
Pre and post implantation loss:
Dose (mg/kg bw/day) Preimplantation loss Postimplantation loss
0 50 34
20 67 25
100 74 38
600 60 25
Number of corpora lutea:
Dose (mg/kg bw/day) No. Corpora lutea
0 487
20 435
100 435
600 418
Duration of Pregnancy: 20 days
Dose (mg/kg bw/day) Mean body weight, grams (GD 20)
0 404.7
20 405.1
100 390.4
600 407.4
Applicant's summary and conclusion
- Conclusions:
- A well reported study conducted according to generally accepted scientific standards and in compliance with GLP reported maternal toxicity (increased incidences of mortality, clinical observations, and slight decreases in body weight gain and food consumption) at 600 mg/kg bw/day. The occurrence of maternal toxicity was accompanied by slight fetal toxicity (increased minor skeletal variations). No significant maternal or developmental effects were observed at 20 or 100 mg/kg bw/day. The maternal and developmental NOAEL was 100 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.
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