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EC number: 203-653-1 | CAS number: 109-17-1
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997-07-01 to 1997-07-04
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Remarks:
- limited documentation of test data and substance purity
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- (1981) and EEC guideline 84/449/EWG, B.4
- Deviations:
- no
- GLP compliance:
- yes
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:
- other: liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
Three healthy adult rabbits of the New Zealand Whte strain were obtained from Harlan Interfauna
(UK) Ltd., Huntingdon, Cambridgeshire, England.
They were in the weight range of 2.4 to 2.6 kg and approximately 10 to 11 weeks of age, prior to
treatment (Day 1). All rabbits were acclimatised to the experimental environrnent.
The rabbits were selected without conscious bias for the study. They were housed individually in meta1
cages with perforated floors in Building R 1 4 Room 5.
A standard laboratory diet SDS Stanrab (P) SQC Rabbit Diet and drinkmg water were provided ad
libitum.
The batch of diet used for the study was analysed for nutrients, contarninants and micro-organisms.
Results of routine physical and chemical examination of drinking water as conducted by the supplier,
are made available to Huntingdon Life Sciences Ltd as quarterly sumrnaries.
Amal room temperature was maintained at 16 to 20°C and relative hurnidity at 52 - 72%. These
environmental pararneters were recorded daily. Air exchange was maintained at approximately 19 air
changes per hour and lighting was controlled by means of a time switch to give 12 hours of artificial
light (0700 - 1900 hours) in each 24 hours period.
Each animal was identified by a numbered aluminium tag placed through the edge of one ear. This
nurnber was unique within the Huntingdon Life Sciences Acute Toxicology Departrnent throughout the
duration of the study. Each cage was identified by a coloured labe1 displayng the study schedule
number, animal number and initials of the Study Director and Home Office licensee.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Untreated skin areas of the test animals serve as the control (clipped).
- Amount / concentration applied:
- 0.5 mL undiluted test substance
- Duration of treatment / exposure:
- 72 hours
- Observation period:
- Examination of the treated skin was made on Day 1 (ie approximately 60 minutes after removal of the
dressings) and on Days 2, 3 and 4 (equivalent to 24, 48 and 72 hours after exposure). - Number of animals:
- 3
- Details on study design:
- TREATMENT PROCEDURE
Approximately 24 hours prior to application of the test substance, hair was removed with electric
clippers from the dorso-lumbar region of each rabbit exposing an area of skm approximately 100 mm x100 mm.
Approximately 0.5 ml of the test substance was applied under a 25 mrn x 25 mrn gauze pad to one
intact skin site on each animal.
Each treatment site was covered with "Elastoplast" elastic adhesive dressing for four hours. The
animals were not restrained during the exposure period and were retumed to their cages immediately
after treatment.
At the end of the exposure penod, the semi-occlusive dressing and gauze pad were removed and the
treatment site was washed with warm water (30' to 40°C) to remove any residual test substance. The
treated area was blotted dry with absorbent Paper.
OBSERVATIONS
Clinical signs
All animals were observed daily for signs of ill health or toxicity
Dermal responses
Examination of the treated skin was made on Day 1 (ie approximately 60 minutes after removal of the dressings) and on Days 2, 3 and 4 (equivalent to 24, 48 and 72 hours after exposure).
SCORING SYSTEM:
Erythema and Eschar Formation
No erythema: 0
Very slight erythema (barely perceptible): 1
Well defined erythema: 2
Moderate to severe erythema: 3
Very severe erythema (beef redness) to eschar formation preventing grading of erythema: 4
Maximum possible: 4
Edema Formation
No edema: 0
Very slight edema (barely perceptible) : 1
Slight edem (edges of area well defined by definite raising):2
Moderate edema (raised approximately 1mm): 3
Severe edema (raised more than 1mm and extending beyond area of exposure):4
Maximum possible: 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Other effects:
- not observed
Any other information on results incl. tables
Overall primary irritation score (PDII): 0.0 of 8 scores FDA (Draize), 1959, re-evaluated according to OECD 404
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Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- not skin irritating
- Conclusions:
- The results demonstrate that TREGDMA is not a dermal irritant
- Executive summary:
In a primary dermal irritation study according to OECD TG 404, New Zealand white rabbits were dermally exposed to 0.5 mL Ethylene glycol dimethacrylate (TREGDMA; CAS 109-16-0) for 72 hours. The mean erythema score was determined to be 0.00 out of 4 and, accordingly, the mean edema score 0.00 out of 4. Systemic toxic effects could not be detected as well.The results demonstrate that TREGDMA is not a dermal irritant.
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