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EC number: 701-308-4 | 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
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- Nanomaterial pour density
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- 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

Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
The extended one generation reproductive toxicity study (EOGRTS) is waived in accordance with Annex XI, section 3.2(a) of the REACH Regulation. The study is waived on the following basis:
i) An exposure assessment covering all relevant exposures throughout the life cycle of the substance demonstrates the absence of or no significant exposure in all scenarios of the manufacture and all identified uses as referred to in Annex VI section 3.5 (see CSR)
ii) A DNEL has been derived from a recently conducted, reliable 90 day sub-chronic study (Envigo study number 41501041). It should be noted that the 90 day study did not demonstrate any adverse effects on reproductive organs or tissues or reveal other concerns in relation with reproductive toxicity.
iii) A comparison of the DNEL with the predicted exposures demonstrates that exposures are always well below the derived DNEL (see CSR).
Link to relevant study records
- Endpoint:
- extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)
- Data waiving:
- exposure considerations
- Justification for data waiving:
- the study does not need to be conducted because relevant human exposure can be excluded as demonstrated in the relevant exposure assessment
- Reproductive effects observed:
- not specified
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
In a subchronic toxicity study the test material was administered to 10 Wistar rats/sex/dose by oral gavage at dose levels of 0, 100, 300 or 1000 mg/kg bw/day. There were no compound-related effects on mortality, clinical signs, body weight, food consumption, hematology, clinical chemistry, organ weights or gross or histopathology. The NOAEL is reported to be 1000 mg/kg bw/day, the highest dose tested. It should be noted that the 90 day study did not demonstrate any adverse effects on reproductive organs or tissues or reveal other concerns in relation with reproductive toxicity.
Effects on developmental toxicity
Description of key information
In a developmental study the test material was administered to Sprage-Dawley rats 24/sex/dose by gavage at dose levels of 0, 100, 300 or 1000 mg/kg bw/day. There were no compound related effects in the dams or the offspring for the parameters monitored.The NOEL is 1000 mg/kg bw/day (the highest dose employed).
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23rd October 2015 to 11th November 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- The Study Plan target range for relative humidity (RH) was 50 ± 20%. This target range was exceeded for one short period during the study, with a maximum humidity of 74% RH being reached.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.31 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- Crl:CD® (SD) IGS BR
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Limited
- Weight at study initiation: 179g to 301g
- Housing: Solid-floor polypropylene cages with stainless steel mesh lids furnished with softwood flakes
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 ºC
- Humidity (%): 50 ± 20%
- Air changes (per hr): at least fifteen air changes per hour
- Photoperiod (hrs dark / hrs light): twelve hours continuous light and twelve hours darkness
IN-LIFE DATES: From: To: 23 October 2015 (first day of treatment) and 11 November 2015 (final day of necropsy) - Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on exposure:
- Polyethylene glycol (PEG 400) was successfully used as the vehicle in the preliminary study, it was also used for this main pre-natal study, utilizing a dosage volume of 4 ml/kg body weight.
- Duration of treatment / exposure:
- Day 3 (pre-implantation) to Day 19 of gestation, inclusive.
- Frequency of treatment:
- Daily.
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Remarks:
- Control - animals were treated in an identical manner with the vehicle alone
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Dose / conc.:
- 300 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 24 animals per dose.
- Control animals:
- yes, concurrent vehicle
- Maternal examinations:
- DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Following arrival, all animals were examined for overt signs of toxicity, ill-health or behavioral changes once daily during the gestation period. Additionally, during the dosing period, observations were performed immediately before and soon after dosing and one hour post dosing.
BODY WEIGHT: Yes
- Time schedule for examinations: Individual body weights were recorded on Day 3 (before the start of treatment) and on Days 5, 6, 7, 8, 11, 14 and 17 of gestation. Body weights were also recorded for animals at terminal kill (Day 20).
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day # 20
- Organs examined: The ovaries and uteri of pregnant females were removed, examined and the following data recorded:
i) Number of corpora lutea
ii) Number, position and type of intrauterine implantation
iii) Fetal sex
iv) External fetal appearance
v) Fetal weight
vi) Placental weight
vii) Gravid uterus weight - Ovaries and uterine content:
- i) Number of corpora lutea
ii) Number, position and type of intrauterine implantation
iii) Fetal sex
iv) External fetal appearance
v) Fetal weight
vi) Placental weight
vii) Gravid uterus weight - Fetal examinations:
- Skeletal alterations and soft tissue alterations, visceral anomalies and skeletal development and anomalies.
- Statistics:
- Body weight and body weight change (including adjustment for the contribution of the gravid uterus), food consumption, gravid uterus weight, litter data and fetal, litter and placental weights and external, visceral and skeletal observations were statitically analysed.
Data were first analysed using Shapiro Wilk normality test and Bartlett’s test for homogeneity of variance. Where there was no significance, parametric methodology was applied using one way analysis of variance and, if significant, Dunnett’s multiple comparison test. Where statistical significance was observed, non parametric methodology was applied using Kruskal-Wallis nonparametric analysis of variance; and, if significant, pairwise analysis of control values against treated values using the Mann-Whitney ‘U’ test. Due to the non-normal distribution of the data, externa , visceral and skeletal observations were generally analyzed using non-parametric methodology.
Probability values (p) are presented as follows:
p<0.01 **
p<0.05 *
p≥0.05 (not significant) - Indices:
- Percentage pre- and post-implantation loss and sex ratio (% male fetuses).
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food efficiency:
- 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):
- Other than generalized fur loss for one female receiving 300 mg/kg bw/day, no macroscopic abnormalities were apparent for females at Day 20 of gestation.
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- 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
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): no effects observed - Changes in number of pregnant:
- no effects observed
- Description (incidence and severity):
- One animal in each of control group and top dose group was found to be non- pregnant.
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- clinical signs
- dead fetuses
- food consumption and compound intake
- mortality
- necropsy findings
- number of abortions
- pre and post implantation loss
- total litter losses by resorption
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Key result
- Abnormalities:
- no effects observed
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): 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
- External malformations:
- no effects observed
- Skeletal malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- At all dosages the incidence of fetuses with costal cartilage not fused to sternebra was higher than control with statistical significance being reached at 100 and 1000 mg/kg bw/day. However there was no dosage-relationship and this isolated finding was considered to be incidental and unrelated to maternal treatment.
- Visceral malformations:
- effects observed, treatment-related
- Description (incidence and severity):
- At 1000 mg/kg bw/day the overall incidence of fetuses showing visceral findings was slightly higher than control but there was no statistically significant increase in any fetal parameter that indicated any clear effect of maternal treatment. This increased incidence was considered most likely to be incidental and unrelated to maternal treatment.
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- changes in sex ratio
- fetal/pup body weight changes
- external malformations
- visceral malformations
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Abnormalities:
- not specified
- Developmental effects observed:
- not specified
- Conclusions:
- The administration off the test material to pregnant rats did not result in any adverse effects on the dams or on the survival, growth and development of the offspring. Therefore the NOEL is considered to be 1000 mg/kg bw/day (highest dose tested).
- Executive summary:
In a developmental study the substance was administered to Sprage-Dawley rats 24/sex/dose by gavage at dose levels of 0, 100, 300 or 1000 mg/kg bw/day. Clinical symptoms, body weight and food consumption were recorded, and the uterus of females (number of corpora lutea, number, position and type of intrauterine implantation, placental weight, gravid uterus weight) and fetuses (total number, sex, weight and external, visceral-one-half and skeletal-one-half defects) were examined.There were no compound related effects in the dams or the offspring for the parameters monitored. The NOEL is 1000 mg/kg bw/day (the highest dose employed).
Reference
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Sufficent to address requirements
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Toxicity to reproduction: other studies
Additional information
The constituents of Small Vinyl Ester do not contain sub-structures that are correlated to teratogenic potential in the MultiCASE human teratogenicity model (bisGMA, dihydroxy-monoGMA and polymeric reaction products) or are outside the model's domain (epoxy-monoGMA). However, the PASS system developed for drugs indicates potential of the constituents for teratogenicity and embryotoxicity. The residual monomer methacrylic acid is assessed by the EU not to be toxic to reproduction.
Justification for classification or non-classification
Based on the findings of the available reproductive toxicity data, classification of the substance is not justified.
Additional information
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.

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