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EC number: 701-440-2 | 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From March 4 to 17, 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- no certificate of analysis of the test substance; individual animal weights not reported
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Esterification products of acrylic acid with reaction products of 2,2-dimethylpropane-1,3-diol and methyloxirane
- EC Number:
- 701-440-2
- Molecular formula:
- (C3H6O)x (C3H6O)y C11H16O4
- IUPAC Name:
- Esterification products of acrylic acid with reaction products of 2,2-dimethylpropane-1,3-diol and methyloxirane
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Highgate Farm, Market Rasen, England
- Age at study initiation: Approximately 9 weeks
- Weight at study initiation: 2.6-2.9 kg
- Housing: Housed individually in stainless steel cages
- Diet: Standard laboratory rabbit diet (Special Diet Services STANRAB (P) SQC pellet), ad libitum
- Water: Drinking water, ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature: Approximately 19 ± 2 °C
- Humidity: 30-70 %
- Photoperiod: 12 h dark / 12 h artificial 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 or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 14 days
- Day 1 (approximately 60 min after removal of the dressings) and Days 2, 3 and 4 (equivalent to approximately 24, 48 and 72 h after exposure).
- Additional observations were made for two animals on Day 5 and for one animal on Days 6 through 14. - Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: Dorso-lumbar region
- % coverage: Test substance was applied under a 2-ply 25 mm X 25 mm porous gauze pad to one intact skin site on each animal.
- Type of wrap if used: Treatment site was covered with "Elastoplast" elastic adhesive dressing.
REMOVAL OF TEST SUBSTANCE
- Washing: After 4 h of exposure period, the semi-occlusive dressing and gauze pad were removed and the treatment site was washed with warm water (36 °C) to remove any residual test substance.
SCORING SYSTEM:
- Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 11 days
- Irritant / corrosive response data:
- - Very slight to well defined erythema with very slight to slight oedema was seen in all animals from Day 2.
- In addition, desquamation (characterised by dryness), thickening of the skin and small scabs on dose site was observed in one rabbit from Day 5.
- Reactions had resolved completely in two animals by either Day 3 or 5, however, very slight erythema was still present in the remaining animal at study termination on Day 14. - Other effects:
- - No signs of toxicity were observed in any animal throughout the observation period.
Any other information on results incl. tables
Table 1: Dermal reactions
Rabbit no. & sex |
E = Erythema
O = Oedema |
Day |
|||||||||||||
1* |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
3790 Male |
E |
0 |
1 |
0 |
0 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
O |
0 |
1 |
0 |
0 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
|
3791 Male |
E |
0 |
2 |
1 |
1 |
0 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
O |
0 |
1 |
0 |
0 |
0 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
|
3792 Male |
E |
0 |
1 |
1 |
2 |
2a |
2a |
2a |
2a |
2a |
1a |
1a |
1a |
1a |
1a |
O |
0 |
1 |
0 |
0 |
1 |
2b |
2b |
2b |
2bc |
1bc |
0 |
0 |
0 |
0 |
* Approximately 60 min after removal of the dressing
- Not applicable
a Desquamation (characterised by dryness)
b Thickening of the skin
c Small scabs on dose site
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- not skin irritating.
- Conclusions:
- Under the test conditions, Propoxylated neopentylglycol diacrylate is not irritating to skin.
- Executive summary:
In a primary dermal irritation study performed according to OECD Guideline 404 and in compliance with GLP, three New Zealand White male rabbits were dermally exposed to 0.5 mL of Propoxylated neopentylglycol diacrylate, under a semi-occlusive patch (25 mm X 25 mm) for 4 h to intact skin of the dorso-lumbar region. Animals were then observed for 14 days. Irritation was scored by the method of Draize at Day 1 (approximately 60 min after removal of the dressing) and Days 2, 3 and 4 (equivalent to 24, 48 and 72 h) after exposure. Additional observations were made for two animals on Day 5 and for one animal on Days 6 through 14.
Very slight to well defined erythema with very slight to slight oedema was seen in all animals from Day 2. In addition, desquamation (characterised by dryness), thickening of the skin and small scabs on dose site was observed in one rabbit from Day 5. Reactions had resolved completely in two animals by either Day 3 or 5, however, very slight erythema was still present in the remaining animal at study termination on Day 14. Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were respectively 0.3, 1.3, 1.3 for erythema and 0.3, 0.3, 0.3 for oedema score. In this study, Propoxylated neopentylglycol diacrylate is not a skin irritant on male rabbits.
Under the test conditions, Propoxylated neopentylglycol diacrylate is not irritating to skin.
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