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EC number: 248-666-3 | CAS number: 27813-02-1
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Appraisal of the safety of Chemicals in foods, drugs and cosmetics by staff of the Division of Pharmacology, FDA acc. to Draize
- Principles of method if other than guideline:
- Method: Appraisal of the safety of chemicals in foods, drugs and cosmetics by the Staff of the Division of Pharmacology, FDA, Hautgiftigkeit nach Draize (1959)
- GLP compliance:
- no
Test material
- Reference substance name:
- Methacrylic acid, monoester with propane-1,2-diol
- EC Number:
- 248-666-3
- EC Name:
- Methacrylic acid, monoester with propane-1,2-diol
- Cas Number:
- 27813-02-1
- Molecular formula:
- C7H12O3
- IUPAC Name:
- 1-hydroxypropan-2-yl 2-methylprop-2-enoate; 2-hydroxypropyl 2-methylprop-2-enoate
- Test material form:
- liquid
- Details on test material:
- The chemical 2-propenoic acid, 2-methyl-, monoester with 1,2-propanediol (CAS No. 27813-02-1) consists of two isomers. This occurs due to the method of industrial production, which is usually either the reaction between methacrylic acid and propylene oxide, or methacrylic acid esterification of 1,2-propanediol. The predominant isomer is the secondary alcohol 2-propenoic acid, 2-methyl, 2-hydroxypropyl ester, which is assigned the CAS No. 923-26-2, and the isomer 2-propenoic acid, 2-methyl, 2-hydroxy- 1-methylethyl ester, the other chemical in this group, for which CAS 4664-49-7 is assigned. The purification of the two isomers requires extensive effort and it is supposed no such effort has been taken during data collection otherwise noted. Therefore toxicity information for both CAS No. 923-26-2 and CAS No. 27813-02-1 is considered to be applicable to both chemicals..
Constituent 1
- Specific details on test material used for the study:
- Supplier: Röhm GmbH, Darmstadt, Germany
Purity: not specified in the report.
Company data in the years of the report: 0,005 to 1 % methacrylic acid
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 2.5 kg (average)
- Housing: individual cages
- Diet: rabbit standard diet (Höing 222)
- Water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 -1 (max. limitation)
- Humidity (%): 50-60
- Photoperiod ( hrs light): 12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved, shaved and scarified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: as a contol 2 areas of the treated animals were also shaved ans scrarified but remained untreated
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied (volume): 0.5 ml - Duration of treatment / exposure:
- 24 hour(s)
- Observation period:
- 72 h
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: rubberized cloth
CONTROL.
- as a contol 2 areas of the treated animals were also shaved and scrarified but remained untreated
REMOVAL OF TEST SUBSTANCE
- Washing : no wahing was done
SCORING SYSTEM:
1. Erythema and scars formation
no erythema 0
very slight erythema 1
clear erythema 2
moderate to severe erythema 3
severe erythema (scarlet red) 4
and slightly scars formation
2. Edema formation
no edema 1
very slight edema 2
moderate edema (thickness ca. 1mm) 3
severe edema (thickness more than 4
1mm, large than the edge of the
contact)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- other: 24/72h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- other: 24/72h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- 0/6 animals had erythema or edema after 72 hours. Mean scores for erythema and edema after 24 and 72 hrs were 0.
Any other information on results incl. tables
- Primary irritation index of the shaved skin
- Primary irritation index of the shaved/scarifized skin
- = fragmentary value
Animal Nr. |
|
| Scores (24 h) | Scores (72 h) |
1 | shaved | Erythema and scras formation | 0 | 0 |
|
| Edema formation | 0 | 0 |
| shaved/scarified | Erythema and scras formation | 0 | 0 |
|
| Edema formation | 0 | 0 |
2 | shaved | Erythema and scras formation | 0 | 0 |
|
| Edema formation | 0 | 0 |
| shaved/scarified | Erythema and scras formation | 1 | 1 |
|
| Edema formation | 1 | 1 |
3 | shaved | Erythema and scras formation | 0 | 0 |
|
| Edema formation | 0 | 0 |
| shaved/scarified | Erythema and scras formation | 1 | 0 |
|
| Edema formation | 1 | 0 |
4 | shaved | Erythema and scras formation | 0 | 0 |
|
| Edema formation | 0 | 0 |
| shaved/scarified | Erythema and scras formation | 0 | 0 |
|
| Edema formation | 0 | 0 |
5 | shaved | Erythema and scras formation | 0 | 0 |
|
| Edema formation | 0 | 0 |
| shaved/scarified | Erythema and scras formation | 0 | 0 |
|
| Edema formation | 0 | 0 |
6 | shaved | Erythema and scras formation | 0 | 0 |
|
| Edema formation | 0 | 0 |
| shaved/scarified | Erythema and scras formation | 1 | 1 |
|
| Edema formation | 0 | 0 |
Animal No. | Primary irritation index |
1 | 0.00 |
2 | 0.00 |
3 | 0.00 |
4 | 0.00 |
5 | 0.00 |
6 | 0.00 |
|
|
X1 | 0.00 |
Animal No. | Primary irritation index |
1 | 0.00 |
2 | 1.00 |
3 | 0.50 |
4 | 0.00 |
5 | 0.00 |
6 | 0.50 |
|
|
X2 | 0.33 |
Total index: X1 + X2= 0.33
Reevaluation according to OECD 404
| Erythema |
| Edema |
|
| 24h | 72h | 24h | 72h |
Animal 1 | 0 | 0 | 0 | 0 |
Animal 2 | 0 | 0 | 0 | 0 |
Animal 3 | 0 | 0 | 0 | 0 |
Animal 4 | 0 | 0 | 0 | 0 |
Animal 5 | 0 | 0 | 0 | 0 |
Animal 6 | 0 | 0 | 0 | 0 |
Mean | 0 | 0 | 0 | 0 |
|
|
|
|
|
Total mean | 0 |
| 0 |
|
| Erythema |
| Edema |
|
|
|
|
|
|
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Classification: not irritating
- Executive summary:
2-Hydroxypropyl methacrylate was tested in a primary skin irritation test to rabbits according to "Appraisal of the safety of chemicals in food, drugs and cosmetics by the Staff of the Division of Parmacology, FDA, 1959 in food, drugs and cosmetics". 6 New Zealand White rabbits were exposed to undiluted HPMA on the shaved and shaved + scarified skin under occlusive conditions for 24 hours. The observation time was 72 hrs. No erythema or edema were observed in any animal after 24 and 72 hrs at the shaved skin.
Therefore in this study 2-hydroxypropyl methacrylate is not irritating to skin according to EU regulation 1271/08 and UN-GHS requirements.
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