Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 201-204-4 | CAS number: 79-41-4
Skin irritation / corrosion
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:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- DOT Packaging Group Classification
- GLP compliance:
- yes
Test material
- Reference substance name:
- Methacrylic acid
- EC Number:
- 201-204-4
- EC Name:
- Methacrylic acid
- Cas Number:
- 79-41-4
- Molecular formula:
- C4H6O2
- IUPAC Name:
- methacrylic acid
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Purity: 99.38% active ingredient
Supplier: Rohm & Haas
Lot No. 6/4/96
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system 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:
- other: semiocclusive (4h/1h) or open (3 min)
- 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:
- in total 4: 1 animal for 4 hr treatment; 3 animals each for 1 hr and 3 min treatment, resp.
- 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. Animals were observed daily for mortality and clinical signs.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- 3 min treatment
- Basis:
- animal: #1, #2
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: perimeter reddened & blanching; concave eschar after 14 d in one animal (another animal euthanized after 7 d)
- Irritation parameter:
- edema score
- Remarks:
- 3 min treatment
- Basis:
- animal: #1, #2
- Time point:
- 24/48/72 h
- Score:
- 2.17
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Remarks:
- 1 hr treatment
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: perimeter reddened & blanching; concave eschar after 14 days for 1 animal (another animal euthanized after 24 hrs)
- Irritation parameter:
- edema score
- Remarks:
- 1 hr treatment
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: another animal euthanized after 24 days
- Irritation parameter:
- erythema score
- Remarks:
- 4 hr treatment
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: exposed area blackened, perimeter reddened and concave eschar after 14 days, 1 animal for 4 hr treatment
- Irritation parameter:
- edema score
- Remarks:
- 4 hr treatment
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 14 days
- 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, concave 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 1 4 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)
- Conclusions:
- Classification: highly corrosive (causes severe burns)
No mortality or clinical signs of systemic toxicity were observed during the study. - Executive summary:
Methacrylic acid was tested in a skin irritation/corrosion test in male rabbits for 4 hrs, 1 hr and 3 min. 3 minutes treatment caused erythema scores of 4 in 2/2 animals which wer not reversibale within 14 days and mean edema scores of 2.17 of 3 max. scores in 2/2 animals which were not fully reversible within 14 days.
Additional tests have been performed with 1h and 4hrs treatment.
No mortality or clinical signs of systemic toxicity were observed during the study.
Based on Classification: highly corrosive (causes severe burns)
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
