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EC number: 226-002-3 | CAS number: 5205-93-6
- 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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Range-finding study, test procedure in accordance with national standard method (US FHSA prodedure) with acceptable restrictions. 24 h exposure, observation period only 72 h
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: according to Federal Hazardous Substances Act (FHSA) procedure
- Principles of method if other than guideline:
- FHSA PRIMARY SKIN IRRITATION/CORROSION
This study is designed to show the degree of skin irritation caused by the test article under evaluation. Six rabbits were used in the test. Twenty
four hours prior to dosing, the hair on each animal's back was removed with clippers. One inch square pieces of the test article were cut and
applied to intact and abraded areas on the skin of each animal. The squares of test article were held in place with surgical tape. To protect the
dosing sites and to promote occlusion, the trunks of each animal were wrapped with gauze, which was held in place with tape. The gauze was then wrapped with an elastic bandage.
After 24 hours, the animals were unwrapped and the article removed. The test sites were observed and scored 24 and 72 hours after dosing. Based on the scores, a Primary Irritation Index was calculated in order to evaluate the material's potential to be a primary irritant. - GLP compliance:
- not specified
Test material
- Reference substance name:
- N-[3-(dimethylamino)propyl]methacrylamide
- EC Number:
- 226-002-3
- EC Name:
- N-[3-(dimethylamino)propyl]methacrylamide
- Cas Number:
- 5205-93-6
- Molecular formula:
- C9H18N2O
- IUPAC Name:
- N-[3-(dimethylamino)propyl]-2-methylacrylamide
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Dimethylaminopropyl Methacrylamide
- Molecular weight (if other than submission substance): 170.25 g/mol
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Weight at study initiation: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): room temperature
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: intact and abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Untreated skin areas of the test animals serve as the control (shaved, scarified).
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL undiluted 3-Dimethylaminopropyl methacrylamide - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 24h and 72h post application
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: back of the animals
- coverage: one inch square pieces
- Type of wrap if used:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): 24 hours after dosing
SCORING SYSTEM: Draize J.H. et al. (1944) (original values)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Remarks:
- intact and abraded skin; evaluation of erythema and edema
- Basis:
- mean
- Remarks:
- Draize score (Draize J.H. et al. 1944)
- Time point:
- other: 24 and 72 hours
- Score:
- 4.3
- Max. score:
- 8
- Reversibility:
- no data
- Remarks:
- structure of tissue not destroyed or changed irreversibly in 24 hours. No formation of edema (intact skin).
- Remarks on result:
- other: Original data, evaluation according to Draize et al., 1944
- Irritation parameter:
- primary dermal irritation index (PDII)
- Remarks:
- intact skin; evaluation of erythema and edema
- Basis:
- mean
- Remarks:
- reevaluation according to GHS-criteria
- Time point:
- other: 24 and 72 hours
- Score:
- 2.8
- Max. score:
- 8
- Reversibility:
- no data
- Remarks:
- structure of tissue not destroyed or changed irreversibly in 24 hours. No formation of edema (intact skin).
- Remarks on result:
- other: GHS-category: 2
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: intact shaved skin
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: intact shaved skin
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: intact shaved skin
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: intact shaved skin
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: intact shaved skin
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: intact shaved skin
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: intact shaved skin
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: intact shaved skin
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: intact shaved skin
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: intact shaved skin
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: intact shaved skin
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: intact shaved skin
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- intact shaved skin, no scoring at 48 h
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- intact shaved skin, no scoring at 48 h
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- intact shaved skin, no scoring at 48 h
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- intact shaved skin, no scoring at 48 h
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- intact shaved skin, no scoring at 48 h
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- intact shaved skin, no scoring at 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- not measured/tested
- Remarks:
- intact shaved skin, no scoring at 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- not measured/tested
- Remarks:
- intact shaved skin, no scoring at 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 48 h
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- not measured/tested
- Remarks:
- intact shaved skin, no scoring at 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 48 h
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- not measured/tested
- Remarks:
- intact shaved skin, no scoring at 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 48 h
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- not measured/tested
- Remarks:
- intact shaved skin, no scoring at 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 48 h
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- not measured/tested
- Remarks:
- intact shaved skin, no scoring at 48 h
Any other information on results incl. tables
Skin irritation scores (original data)
Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Erythema (animals 1 -6) |
Edema (animals 1 -6) |
Max. score: 4 |
Max. score: 4 |
|
24 h intact skin 24 h scarified skin |
4/4/3/3/3/3 4/4/3/3/3/3 |
0/0/0/0/0/0 2/3/3/3/3/3 |
72 h intact skin 72 h scarified skin |
3/3/2/2/2/2 4/4/3/3/3/3 |
0/0/0/0/0/0 2/3/2/2/2/2 |
Average 24h, 72h intact skin Average 24h, 72h scarified skin |
2.8 3.3 |
0 2.5 |
Average 24h, 72h intact and scarified skin |
3.05 |
1.25 |
|
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant)
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- N-Dimethylaminopropylmethacrylamide is slightly irritating according to the Draize et al. (1944) scoring system.
The reevaluation of the study results according to GHS-criteria reveal to GHS-category: 2 for N-Dimethylaminopropylmethacryamide. Therefore
N-Dimethylaminopropylmethacrylamide would be classified as skin irritating according to GHS-criteria. - Executive summary:
In a primary dermal irritation study 6 rabbits (strain: no data, sex: no data) were dermally exposed via a covered patch (FHSA-procedure) to 0.5 ml undiluted (intact and abraded skin) Dimethylaminopropyl Methacrylamide (purity: >=98%) for 24 hours. Animals then were observed for 3 days. Irritation was scored by the method of Draize et al. 1944.
In this study, Dimethylaminopropyl Methacrylamide is not a dermal irritant as primary irritation score of 4.3 out of 8 is less than 5.0 evaluation
according to Draize et al., 1944.
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