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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:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Method in accordance with OECD Guideline, GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
other: DOT Packing Group Classification
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Methacrylic acid (CAS: 79-41-4)
Purity: 99.38 %
Supplier: Rohm & Haas
Lot 6/4/96; Sample no 96-054; clear liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Adult male animals were obtained from Hazelton Research Animals. All animals were examined and quarentined for two weeks. Animals were housed
individually in environementally controlled rooms. At the time of dosing, animals were 19 - 30 weeks old and weighed from 2733-3484 grams.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4 hrs, 1 hr or 3 minutes
Observation period:
Skin irritation was evaluated at 1, 24, 48, 72 hrs and 7 and 14 days after patch removal.
Number of animals:
5
Details on study design:
0.5 ml of the test subtance were applied to the clipped skin for 4 h under semi-occluded conditions to one rabbit, for 1 h under semi-occluded 
conditions to 2 rabbits, and for 3 minutes uncovered to 2 rabbits. After the exposure period the application sites were wiped with paper towels 
saturated with water or with a 1% ivory-soap solution prior to the tap water rinse and thereafter blotted dry with paper towels. Animlas were observed daily for mortality and clinical signs.

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Remarks:
intact skin; evaluation of erythema and edema
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
6.17
Max. score:
8
Reversibility:
not reversible
Remarks:
after 3 minutes of application of MAA
Remarks on result:
other: Classification: highly corrosive (causes severe burns)
Irritant / corrosive response data:
On all sites (4 h, 1h, 3 min exposure) skin irritation indicative of corrosivity (concave eschar formation) was observed. 
4 h exposure: erythema: 1h-14d: 4, cocncave eschar at day 7 and 14. Edema: 1 h: 4, 24 h: 3, 48 h: 2, 3d, 7d, 14d: 1
1 h exposure: animal 1: erythema: 4, blanching, concave eschar at day 7 and 14, edema: 1, 24 h: 3, 48, 72 h: 2, 7, 14 d: 1; animal 2: skin pulled off at 
time of patch removal, all layers of dermis destroyed.
3 min exposure: erythema: 4 both animals, all time points. blanching, concave escar from day day 2 (1 animal) or 7 (1 animal) to day 14. One animal 
was killed at day 7 when conclusive evidence of irreversible damage to the dermis was noted.
Other effects:
No mortality or clinical signs of systemic toxicity were observed during the study.

Any other information on results incl. tables

Methacrylic Acid

Skin lrritation Scores (Draize Criteria) - 3 Minutes

ERYTHEMA (maximal score 4):

Time After Patch Removal

-------------------------------------------------------------------------------------------------

Animal No. 1 hr 24 hrs 48 hrs 72 hrs 7 days 14 days

96-27199 4e 4ef 4ef 4ef 4 def 4 def

96-27243 4f 4cf 4cd 4cd 4 cd -

-----------------------------------------------------------------

EDEMA (maximal score 4):

Animal No.

96-27199 3 3 2 2 1 1

96-27243 3 3 2 1 1 -

c. Blackened

d. Concave eschar

e. Application site perimeter: reddened

f. Application site perimeter: blanching

(-) No applicable data. Animal was euthanized after Day 7 scores when conclusive

evidence of irreversible damage to the dermis was noted.


Applicant's summary and conclusion

Interpretation of results:
Category 1A (corrosive)
Remarks:
Migrated information according to REGULATION (EC) No 1272/2008 Criteria used for interpretation of results: EU
Conclusions:
Classification: highly corrosive (causes severe burns)
No mortality or clinical signs of systemic toxicity were observed during the study.
Executive summary:

Classification: highly corrosive (causes severe burns)

No mortality or clinical signs of systemic toxicity were observed during the study.