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EC number: 203-652-6 | CAS number: 109-16-0
- 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
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- sub-chronic toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 003
Materials and methods
- Principles of method if other than guideline:
- subchronic study according to EPA Dermal Bioassay Workshops (April 28-29, 1987 and May 18-19, 1988).
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 2,2'-ethylenedioxydiethyl dimethacrylate
- EC Number:
- 203-652-6
- EC Name:
- 2,2'-ethylenedioxydiethyl dimethacrylate
- Cas Number:
- 109-16-0
- Molecular formula:
- C14H22O6
- IUPAC Name:
- ethane-1,2-diylbis(oxyethane-2,1-diyl) bis(2-methylacrylate)
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): triethylene glycol dimethacrylate
Test animals
- Species:
- mouse
- Strain:
- other: C3H/HeNHsd
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Sprague-Dawley (Indianapolis, IN)
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 2-3 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 65-77
- Humidity (%): 40-70%
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- open
- Vehicle:
- acetone
- Details on exposure:
- TEST SITE
applied to the clipped interscapular region of the back
- Type of wrap if used: no wrap
- Time intervals for shavings or clipplings: during the week prior to the first dose and as needed during the dosing period, the fur was clipped from the dorsal area of the trunk
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µL
- Concentration (if solution): 5, 25, 50, 100%
USE OF RESTRAINERS FOR PREVENTING INGESTION: no - Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- 5 d/week
Doses / concentrationsopen allclose all
- Dose / conc.:
- 100 mg/kg bw/day
- Remarks:
- = 5 %
- Dose / conc.:
- 500 mg/kg bw/day
- Remarks:
- = 25 %
- Dose / conc.:
- 1 000 mg/kg bw/day
- Remarks:
- = 50 %
- Dose / conc.:
- 2 000 mg/kg bw/day
- Remarks:
- = 100 %
- No. of animals per sex per dose:
- 10 males
- Control animals:
- yes, concurrent no treatment
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- DERMAL IRRITATION (if dermal study): Yes
- Time schedule for examinations: weekly starting 1 week before dosing
BODY WEIGHT: Yes
- Time schedule for examinations: weekly starting 1 week before dosing
HAEMATOLOGY: Yes
- Time schedule for collection of blood: prior to sacrifice
- How many animals: 5/group
NECROPSY: YES
ORGAN WEIGHTS: YES
-liver, kidneys, spleen, brain and testes were weighed.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: prior to sacrifice
- How many animals: 5/group
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: weekly starting 1 week before dosing
- Dose groups that were examined: all groups
- Battery of functions tested: observation in an open arena and the following endpoints were evaluated: stereotypy, arousal, approach response, startle response, tail pinch, salivation, Iacrimation, mouthbreathing, piloerection, gait, muscle tone, air righting reflex, convulsions, tremors, and diarrhea
OTHER: cutaneous cell proliferation evaluations using the PCNA procedure in 5/test group and 10/control group - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes (high dose group; Iungs, liver, kidneys, spleen, stomach, and gross lesions in all dose groups) - Other examinations:
- Proliferating cell nuclear antigen (PCNA) immunohistochemical analysis
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Dermal irritation:
- effects observed, treatment-related
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- 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:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- inreased liver weights in 50 and 100% groups, but no clinical or histopathological evidence of liver toxicity
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- no other than dermal effects
- Histopathological findings: neoplastic:
- not examined
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Remarks:
- local
- Effect level:
- 100 mg/kg bw/day
- Based on:
- act. ingr.
- Sex:
- male
- Basis for effect level:
- other: acanthosis, hyperkeratosis
- Remarks on result:
- other: = 5%
- Dose descriptor:
- NOAEL
- Remarks:
- systemic
- Effect level:
- 2 000 mg/kg bw/day
- Based on:
- act. ingr.
- Sex:
- male
- Remarks on result:
- other: = 100%; no relevant systemic effects observed
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
For TREGDMA-treated animals, exfoliation/desquamation was observed in all animals of the 25, 50 and 100% dose groups at some time during the study. Ulceration and excoriation also were seen in a few animals from these groups that resolved by day 35. No findings were recorded in the 5% dose group.
Hyperkeratosis was observed in all animals from the 25, 50, and 100% dose groups and acanthosis was observed in 80 or 100% of the animals from these groups. A single animal was diagnosed with dermatitis from the 100% group. Grading of these lesions generally correlated with dose. No microscopic changes of the skin were noted for the 5% dosage.
Skin basal cell proliferation (PCNA assay) was increased in the 25, 50, and 100% groups, but statistically significant only in the 100% group.
Applicant's summary and conclusion
- Conclusions:
- The 13 week-NOAEL of TREGDMA in mice for local effects (acanthosis, hyperkeratosis) was 5% in acetone (approx. 100 mg/kg bw/d). The 13 week-NOAEL for systemic effects was 100% (approx. 2000 mg/kg bw/d).
- Executive summary:
In a 13 weeks dermal toxicity study, TREGDMA (91% a.i.) was applied to the clipped interscapular region of the back of 10 maleC3H/HeNHsd mice/dose at dose levels of 0 (control), 5, 25, 50 and 100% TREGDMA in acetone, corresponding to approx. 100, 500, 1000 and 2000 mg/kg bw/d. The doses were applied in 50 µL/animal/day 5 days per week.
During the treatment phase of the study, no effects were observed except for skin lesions at the site of treatment. Exfoliation and desquamation was observed in all animals of the 25, 50 and 100% dose groups at some time during the study. Ulceration and excoriation also were seen in a few animals from these groups that resolved by day 35. No findings were recorded in the 5% dose group.
The only treatment-related finding at necropsy, other than for treated skin, was an increase in liver weight of approx. 7 and 10% compared with the control group in the 50 and 100% groups, respectively. There was no clinical or histopathological evidence of liver toxicity, thus the etiology and biological significance of the increased weight was uncertain.
Hyperkeratosis was observed in all animals from the 25, 50, and 100% dose groups and acanthosis was observed in 80 or 100% of the animals from these groups. A single animal of the 100% group was diagnosed with dermatitis. No microscopic changes of the skin were noted for the 5% dosage.
Skin basal cell proliferation (PCNA assay) was increased in the 25, 50, and 100% groups, but was statistically significant only in the 100% group.
In this study, the 13 week-NOAEL of TREGDMA for local effects (acanthosis, hyperkeratosis) was 5% (approx. 100 mg/kg bw/d). The 13 week-NOAEL for systemic effects was 100% (approx. 2000 mg/kg bw/d).
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