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Diss Factsheets
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EC number: 221-950-4 | CAS number: 3290-92-4
- 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://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From July 05 to 08, 2005
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 24 April 2002
- Deviations:
- yes
- Remarks:
- systemic effects not followed; animals not weighed at the end of the study
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Propylidynetrimethyl trimethacrylate
- EC Number:
- 221-950-4
- EC Name:
- Propylidynetrimethyl trimethacrylate
- Cas Number:
- 3290-92-4
- Molecular formula:
- C18H26O6
- IUPAC Name:
- 2,2-bis[(methacryloyloxy)methyl]butyl methacrylate (non-preferred name)
- Test material form:
- other: Clear colourless liquid
- Details on test material:
- - Name of test material (as cited in study report): TMPTMA
- Physical state: Clear colourless liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd, Moston, UK
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.0-3.5 kg
- Housing: Individually housed in suspended cages
- Diet (e.g. ad libitum): Certified Rabbit Diet (Code 5322) (BCM IPS Limited, London, UK), ad libitum
- Water (e.g. ad libitum): Mains drinking water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C
- Humidity (%): 30-70%
- Air changes (per hour): 15/hour
- Photoperiod (hours dark / hours light): 12 hours dark / 12 hours light
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- Three males
- Details on study design:
- TEST SITE
- Area of exposure: Dorsal flank area
- Type of wrap if used: Test material (0.5 mL) was applied beneath a gauze (2.5 cm X 2.5 cm), placed directly on the test sites and then secured in position with surgical adhesive tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test material was removed by gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24H
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24h
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- - Very slight erythema was observed at the application sites which subsided within 24 hours
- See table 1 for individual animal scores - Other effects:
- No
Any other information on results incl. tables
Table 1: Individual skin reactions
Rabbits No. |
62 Male |
63 Male |
64 Male |
|
Erythema/Eschar |
1 hour |
1 |
1 |
1 |
24 hours |
0 |
0 |
0 |
|
48 hours |
0 |
0 |
0 |
|
72 hours |
0 |
0 |
0 |
|
Mean (24 hours + 48 hours + 72 hours) |
0 |
0 |
0 |
|
Oedema |
1 hour |
0 |
0 |
0 |
24 hours |
0 |
0 |
0 |
|
48 hours |
0 |
0 |
0 |
|
72 hours |
0 |
0 |
0 |
|
Mean (24 hours + 48 hours + 72 hours) |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- not skin irritating
- Conclusions:
- Under the test conditions, TMPTMA is not classified as irritating to the skin according to the CLP Regulation (EC) N° (1272-2008).
- Executive summary:
In a primary dermal irritation GLP study performed according to OECD guideline 404, three New-Zealand white male rabbits were dermally exposed to 0.5 mL of TMPTMA, under a semi-occlusive bandage (25 cm X 25 cm) for 4 hours to clipped skin of dorsal flank area. Animals then were observed for 72 hours. Irritation was scored by the method of Draize (1959).
Very slight erythema was observed at the application sites which subsided within 24 hours. Mean individual scores at 24, 48 and 72 hours after removal of the test material for the 3 animals were 0, 0, 0 for erythema/oedema score. In this study, TMPTMA is not a dermal irritant on male rabbits.
Under the test conditions, TMPTMA is not classified as irritating to the skin according to the criteria of the CLP Regulation (EC) N° 1272-2008.
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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