Registration Dossier
Registration Dossier
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EC number: 201-297-1 | CAS number: 80-62-6
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:
- test procedure in accordance with national standard methods
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"; Division of Pharmacology, FDA; according to the Draize Test, 1959
- Principles of method if other than guideline:
- Application: occlusive instead of semiocclusive
Exposute time: 24 hours instead of 4 hours - GLP compliance:
- no
Test material
- Reference substance name:
- Methyl methacrylate
- EC Number:
- 201-297-1
- EC Name:
- Methyl methacrylate
- Cas Number:
- 80-62-6
- Molecular formula:
- C5H8O2
- IUPAC Name:
- methyl 2-methylprop-2-enoate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Provided by Röhm GmbH, Darmstadt
- Name of test material (as cited in study report): Methylmethacrylat
- Physical state: clear liquid
- Analytical purity: no data
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Mean weight at study initiation: 2.5 kg
- Housing: single
- Diet (ad libitum): Hoeing 222
- Water (ad libitum): not specified
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+-1
- Humidity (%): 50-60
- Photoperiod (hrs dark / hrs light): 12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated areas on test animals served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 ml - Duration of treatment / exposure:
- 24 h
- Observation period:
- 24 and 72 hrs
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2.5*2.5 cm
- Type of wrap if used: rubberised cloth
REMOVAL OF TEST SUBSTANCE
- Washing: not performed
- Time after start of exposure: 24 h
SCORING SYSTEM: according to the OECD/Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #3, #4, #6
- Time point:
- other: mean 24/ 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effcts
- Remarks on result:
- other: see table for details
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- other: mean 24/72h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: see table for details
- Irritation parameter:
- edema score
- Basis:
- animal: #1; #2; #3; #4; #5; '6
- Time point:
- other: mean 24/72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- other: see table for details
Any other information on results incl. tables
| Exposition: | 24 h occlusive, shaved skin | |||
| Animal | Reading | Erythema | Edema | Symptoms |
| 1 | 24 h | 0 | 0 | |
| 2 | 24 h | 0 | 0 | |
| 3 | 24 h | 0 | 0 | |
| 4 | 24 h | 0 | 0 | |
| 5 | 24 h | 1 | 0 | |
| 6 | 24 h | 0 | 0 | |
| 1 | 72 h | 0 | 0 | |
| 2 | 72 h | 0 | 0 | |
| 3 | 72 h | 0 | 0 | |
| 4 | 72 h | 0 | 0 | |
| 5 | 72 h | 0 | 0 | |
| 6 | 72 h | 0 | 0 | |
| mean animal 1 | 24 - 72 h | 0.00 | 0.00 | |
| mean animal 2 | 24 - 72 h | 0.00 | 0.00 | |
| mean animal 3 | 24 - 72 h | 0.00 | 0.00 | |
| mean animal 4 | 24 - 72 h | 0.00 | 0.00 | |
| mean animal 5 | 24 - 72 h | 0.50 | 0.00 | |
| mean animal 6 | 24 - 72 h | 0.00 | 0.00 | |
| mean | 24 - 72 h | 0.08 | 0.00 | |
---
The mean erythema and edema scores of the 24 and 72 h readings of the scarified skin sites were 0.25 and 0.0, respectively. The slight erythema were fully reversible within 72 h.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Executive summary:
In an acute dermal irritation test acc. to Draize 1959 6 New Zealand White rabbits were exposed to methyl methacrylate under occlusive conditions for 24 hours on the shaved skin. Very slight erythema was observed in one animal which was fully reversible within 72 h.
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