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Toxicological information

Skin irritation / corrosion

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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:
1977

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

Constituent 1
Chemical structure
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 methacrylate
Test material form:
liquid
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.