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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
Endpoint summary
Administrative data
Description of key information
The substance was found to be corrosive to skin and non-irritating to eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
- 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
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- not specified
- 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 - Species:
- rabbit
- Strain:
- not specified
- 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
- 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.
- 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.
Referenceopen allclose all
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.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Initiation date: 25-11-1986, Completion date: 28-11-1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- not specified
- 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
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 - Species:
- rabbit
- Strain:
- not specified
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- not specified
- Duration of treatment / exposure:
- single treatment
- Observation period (in vivo):
- 43 minutes, 24 hr, 48 hr and 72 hr
- Number of animals or in vitro replicates:
- three female rabbits
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.2
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Instillation of the test substance into one of the eyes of three female rabbits slightly affected the conjunctivae. Approximately 43 minutes after exposure all three animals showed slight conjunctival redness only. In animals 3077 and 3083 the reddening had disappeared the next day and in animal 3081, 72 hours after instillation of the test substance.
Adverse effects on the cornea and the iris were not observed in any of the rabbits during the entire observation period. Treatment of the eyes with fluorescein 24 hours after instillation of the test substance did not reveal any epithelial damage. During the first few hours after exposure lacrimation was observed in all rabbits and in animal 3083 discharge was slightly higher.
Signs of systemic intoxication were not observed. Based on the calculated Oraize score of 2 (1 hour) the test substance should be classified as minimally irritating according to the scheme of Kay and C alandra (1962). According to the EEC criteria for classification and labelling of dangerous substances, the test substance need not be labelled as an eye-irritant. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to the EEC criteria for classification and labelling of dangerous substances, the test substance need not be labelled as an eye-irritant.
- Executive summary:
The purpose of the study was to evaluate the ability of the test substance to produce ocular irritation or corrosion in the rabbit following a single. application to the eye. The substance was found to be a non-irritant. According to the EEC criteria for classification and labelling of dangerous substances, the test substance need not be labelled as an eye-irritant.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
The substance was found to be corrosive to skin (Cat. 1C) and non-irritating to eyes.
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