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EC number: 224-116-8 | CAS number: 4203-89-8
- 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:
- Initiation date: 04-11-1986, Completion date: 25-11-1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 2-(1-oxa-4-azaspiro[4.5]dec-4-yl)ethyl methacrylate
- EC Number:
- 224-116-8
- EC Name:
- 2-(1-oxa-4-azaspiro[4.5]dec-4-yl)ethyl methacrylate
- Cas Number:
- 4203-89-8
- Molecular formula:
- C14H23NO3
- IUPAC Name:
- 2-{1-oxa-4-azaspiro[4.5]decan-4-yl}ethyl 2-methylprop-2-enoate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Chemical name (IUPAC): Methacrylic acid, 2-(1 oxa-4-aza spiro [4,5] dec-4-yl ethyl ester)
Commercial name: Nourycryl MA 128
Batch no.: 860930 - DT4
Purity: >99%; major impurity p -methoxyphenol (100 ppm)
Solubility: Soluble in ethanol and toluene, decomposes in water
Appearance: Clear slightly yellow liquid
Storage: At ambient temperature in the dark in the presence of silica gel
Test animals
- Species:
- rabbit
- Strain:
- not specified
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- shaved
- Vehicle:
- not specified
- Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- not specified
- Duration of treatment / exposure:
- single application
- Observation period:
- The exposed skin areas were examined for signs of erythema and oedema and the responses were scored at 60 minutes, and approximately 24, 48 and 72 hours, and 7, 14 and 21 days after removal of the patches. For reference the control site on the contralateral flank was used. In order to facilitate the scoring, the skin area concerned of all animals was shaved again at least 5.5 hours before the observations on day 1, 3, 7, 14 and 21.
- Number of animals:
- three
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 1-3
- Time point:
- 24/48/72 h
- Score:
- >= 2 - <= 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: 1-3
- Time point:
- 24/48/72 h
- Score:
- >= 2 - <= 3
- Max. score:
- 3
- Reversibility:
- other: reversibility not clear due to eschar formation
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- One hour after removal the test substance the skin of all three rabbits showed well-defined erythema and obvious to moderate oedema. The erythema increased to severe followed by eschar formation, in animal 3095 already after 24 hours, while animals 3097 and 3099 showed eschar formation on day 7. During the following weeks the treated skin did not heal, all three rabbits revealed eschar formation and a slightly thicker and less flexible skin. When the study was terminated on day 21, the exposed skin of animals 3097 and 3099 showed no or very little hair growth, less flexibility and clear reddening indicating chronic dermal inflammation. In animal 3095, the skin revealed the same symptoms and also scar tissue. Signs of systemic intoxication were not observed in any of the rabbits. The calculated primary irritation index (modified) is 5.0.
Any other information on results incl. tables
Primary Skin Irritation Scores For Nourycryl MA 128 in the Rabbit
Rabbit no. and sex |
Body weight (grams) |
Observation time after exposure period (hours) |
Erythema |
Oedema |
3095, female |
2744 |
1 |
2 |
3 |
|
|
24 |
4h) |
3 |
48 |
4h) |
2 |
||
72 |
4h) |
3 |
||
Day 7 |
4 |
_d) |
||
Day 14 |
4 |
_d) |
||
Day 21 |
_g) |
_e) |
||
Subtotal a)/Mean value c) |
12/4.0 |
8/2.7
|
||
3097, female |
2457 |
1 |
2 |
2 |
|
|
24 |
2 |
2 |
48 |
2 |
2 |
||
72 |
2 |
2 |
||
Day 7 |
4 |
_d) |
||
Day 14 |
_f) |
0 |
||
Day 21 |
_f) |
_e) |
||
Subtotal a)/Mean value c)
|
6/2.0 |
6/2.0 |
||
3099, female |
2697 |
1 |
2 |
2 |
|
|
24 |
2 |
2 |
|
|
48 |
2 |
2 |
|
|
72 |
2 |
2 |
|
|
Day 7 |
4 |
_d) |
|
|
Day 14 |
_f) |
0 |
|
|
Day 21 |
_f) |
_e) |
Subtotal a)/Mean value c)
|
6/2.0 |
6/2.0 |
||
Total a)/Mean value c)
|
24/2.7 |
20/2.2 |
Notes
a) Subtotal = sum of 24-, 48 - and 7 2 -hour scores for each animal individually
b) Total = sum of 24-, 48- and 7 2 -hour scores calculated over all animals.
c) Mean value = mean score of 24-, 48 - and 7 2 -hour reading times.
d) Difficult to score due to eschar formation.
e) Treated skin slightly thicker and less flexible than normal.
f) No or very little hair growth, exposed skin clearly red.
g) No hair growth, exposed skin clearly red with white areas of scar tissue.
h) The exposed skin revealed partial necrosis.
Primary irritation index (modified)*= 5.0
* Total of 24- and 7 2-hour scores for erythema and oedema, divided by 6.
It should be noted that the original Draize primary skin irritation index applies to the combined average of the scores for intact and abraded skin. In this study the test substance was applied to intact skin.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1C (corrosive) based on GHS criteria
- Remarks:
- After 4 hr exposure; 1/3 animals showed necrosis after 24 hr and scar tissue visible after 21 days.
- Conclusions:
- The calculated primary irritation index (modified) is 5.0. One animal showed visible necrosis and effects were not fully reverisble within 21 days. The substance was found to be corrosive to skin.
- Executive summary:
The purpose of the study was to evaluate local irritating or corrosive effects on the rabbit skin following a single application of the test substance. The study was performed according to OECD TG 404.
One hour after removal the test substance the skin of all three rabbits showed well-defined erythema and obvious to moderate oedema. The erythema increased to severe followed by eschar formation, in animal 3095 already after 24 hours, while animals 3097 and 3099 showed eschar formation on day 7; During the following weeks the treated skin did not heal, all three rabbits revealed eschar formation and a sslightly thicker and less flexible skin. When the study was terminated on day 21, the exposed skin o f animals 3097 and 3099 showed no or very little hair growth, less flexibility and clear reddening indicating chronic dermal inflammation. In animal 3095, the skin revealed the same symptoms and also scar tissue. Signs o f systemic intoxication were not observed in any of the rabbits.
The substance was found to be corrosive to skin and classified as Category 1C (corrosive) based on GHS criteria.
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