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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 248-666-3 | CAS number: 27813-02-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
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
- 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 bis 1 % methacrylic acid
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 2.4 to 2.6 kg
- Housing: individual cages
- Diet : standard diet (Höing 222)
- Water ad libitum:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 °C
- Humidity (%): 50-60
- Photoperiod hrs light): 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied (volume): 0.1 ml
- Concentration: undiluted - Duration of treatment / exposure:
- till end of observation period
- Observation period (in vivo):
- 24, 48, 72 h, 4, 5, 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no washing:
SCORING SYSTEM:
Scoring system for the evaluation of ear lesions Scores
1. Cornea
A. Opacity - Grade of opacity (the most opac area will be used for evaluation)
No opacity 0
Motteled or diffuse opacity
(details if iris good visible) 1
Slightly differentiated opac areas,
details of iris slightly ambiguous 2
Opac areas, no details of iris are visible,
size of pupil hardly visible 3
Opacity, iris unvisible 4
B. Size of involved total area
¼ or less but not zero 1
More than ¼, but less than ½ 2
Larger than ½ but less than ¾ 3
Larger than ¾ up to total area 4
A x B x 5 total maximum number = 80
2. Iris
A. Evaluation
Normal 0
Increasing wrinkle formation (washy trabecules )
Blood overfilling, swelling, vascular dilatation at
the edge of cornea (when one or more symptoms
occur) iris shows still light reaction (delayed
reaction is deemed to be positive) 1
No reaction against light, bleeding, changes in
iris structure (one or more symptoms) 2
A x 5 total maximum number =10
3. Conjunctiva
A. Redness
Vascular normal 0
Vascular definitely more than normal injected 1
More diffuse crimson colour, single vascular
difficult to identify 2
Diffuse flesh colour 3
B. Chemosis
No swelling 0
More than normal swelling (including nictitating membrane) 1
Definite swelling with lifting the lids 2
Swelling with semi-closed lids 3
Swelling that lids are more than semi-closed or totally
closed 4
C. Secretion
No secretion 0
Every increased secretion (not included the physiological
secretion at the inner canthus) 1
Secretion with moistening the lids and the
neighboring hairs 2
Secretion with wettening the lids and the neighboring
hairs largely beyond the eye 3
Total number (A+B+C) x 2 total maximum number = 20
The total number for the eye is the summation of the scores for cornea, iris and conjunctiva
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3, #4, #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #3, #4, #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2, #3, #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal: #4, #6
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- probability of weak irritation
- Irritant / corrosive response data:
- HPMA produced corneal opacity scored 1 in 5/6 animals which was fully reversible within 4 days in all animals. This result triggers classification for eye irritation into Category 2.
One animal showed conjunctival redness scored 2. Iritis and chemosis were < 1 or < 2, respectively in all other animals
Any other information on results incl. tables
|
|
Day |
||||||
Animal No. 1 |
|
1 |
2 |
3 |
4 |
5 |
6 |
7 |
1. Cornea |
A |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
|
B |
2 |
2 |
2 |
0 |
0 |
0 |
0 |
2. Iris |
A |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3. Conjunctiva |
A |
2 |
1 |
1 |
0 |
0 |
0 |
0 |
|
B |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
C |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
|
|
Day |
||||||
Animal No. 2 |
|
1 |
2 |
3 |
4 |
5 |
6 |
7 |
1. Cornea |
A |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
|
B |
2 |
2 |
2 |
0 |
0 |
0 |
0 |
2. Iris |
A |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3. Conjunctiva |
A |
2 |
2 |
2 |
0 |
0 |
0 |
0 |
|
B |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
C |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
|
|
Day |
||||||
Animal No. 3 |
|
1 |
2 |
3 |
4 |
5 |
6 |
7 |
1. Cornea |
A |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
|
B |
2 |
2 |
2 |
0 |
0 |
0 |
0 |
2. Iris |
A |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3. Conjunctiva |
A |
2 |
1 |
0 |
0 |
0 |
0 |
0 |
|
B |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
C |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
|
|
Day |
||||||
Animal No. 4 |
|
1 |
2 |
3 |
4 |
5 |
6 |
7 |
1. Cornea |
A |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
|
B |
2 |
2 |
2 |
0 |
0 |
0 |
0 |
2. Iris |
A |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3. Conjunctiva |
A |
2 |
1 |
0 |
0 |
0 |
0 |
0 |
|
B |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
|
C |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
|
|
Day |
||||||
Animal No. 5 |
|
1 |
2 |
3 |
4 |
5 |
6 |
7 |
1. Cornea |
A |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
B |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2. Iris |
A |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3. Conjunctiva |
A |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
|
B |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
C |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
Day |
||||||
Animal No. 6 |
|
1 |
2 |
3 |
4 |
5 |
6 |
7 |
1. Cornea |
A |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
|
B |
2 |
2 |
2 |
0 |
0 |
0 |
0 |
2. Iris |
A |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3. Conjunctiva |
A |
2 |
1 |
0 |
0 |
0 |
0 |
0 |
|
B |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
|
C |
3 |
1 |
0 |
0 |
0 |
0 |
0 |
Summary of the eye observations |
|||||||
|
Day |
||||||
Animal No. |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
1 |
16 |
14 |
14 |
0 |
0 |
0 |
0 |
2 |
16 |
16 |
16 |
0 |
0 |
0 |
0 |
3 |
16 |
14 |
10 |
0 |
0 |
0 |
0 |
4 |
18 |
14 |
10 |
0 |
0 |
0 |
0 |
5 |
6 |
0 |
0 |
0 |
0 |
0 |
0 |
6 |
22 |
14 |
10 |
0 |
0 |
0 |
0 |
Mean |
15.67 |
12 |
10 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2B (mildly irritating to eyes) based on GHS criteria
- Conclusions:
- HPMA is irritating to eyes. Classification: Category 2, H319 (CLP criteria) and Category 2B (GHS criteria)
- Executive summary:
2 -Hydroxypropyl methacrylate was tested in an eye irritation test to rabbits according to the Appraisal of the safety of Chemicals in foods, drugs and cosmetics by staff of the Division of Pharmacology, FDA acc. to Draize (1959). 6 New Zealand White rabbits were treated with 0.1 ml of the undilited test substance and were observed for 7 days. HPMA produced corneal opacity scored 1 in 5/6 animals which was fully reversible within 4 days in all animals.
One animal showed conjunctival redness scored 2. Iritis and chemosis were < 1 or < 2, respectively in all other animals
The study was reevaluated according to GHS criteria and EU regulation 1272/2008. The substance is irritating to eyes, Category 2B (GHS criteria) and Category 2, H319 (EU regulation 1272/2008, CLP criteria).
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.
