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EC number: 221-657-1 | CAS number: 3179-47-3
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- Irritation / corrosion
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![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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: Comparable to guideline study. 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: according to Appraisal of the Safety of Chemicals in foods, drugs and cosmetics, FDA Draize (1959)
- Principles of method if other than guideline:
- Method: according to Appraisal of the Safety of Chemicals in foods, drugs and cosmetics, FDA Draize (1959)
- GLP compliance:
- no
Test material
- Reference substance name:
- Decyl methacrylate
- EC Number:
- 221-657-1
- EC Name:
- Decyl methacrylate
- Cas Number:
- 3179-47-3
- Molecular formula:
- C14H26O2
- IUPAC Name:
- decyl 2-methylprop-2-enoate
- Details on test material:
- - Name of test material (as cited in study report): Decyl methacrylat, roh
Constituent 1
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 - 2,6 kg
- Housing: single housing
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18°C
- Humidity (%): 45 - 55 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of each treated animal
- Amount / concentration applied:
- undiluted
Amount applied: 0.1 ml - Duration of treatment / exposure:
- 72 hours, unrinsed
- Observation period (in vivo):
- 7 days after treatment
- Number of animals or in vitro replicates:
- 6
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hr
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: not rinsed
- Irritation parameter:
- other: index of primary eye irritation
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hr
- Score:
- 0
- Max. score:
- 13
- Reversibility:
- fully reversible
- Remarks on result:
- other: re-evaluated according to OECD405
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Index of primary eye irritation: 0.0 of 13 (re-evaluated according to
OECD 405)
An initial slight irritation of the conjunctiva within the first 8 hours
(irritation scores 0 -2) disappeared entirely within the first 24 h; non-irritating
Classification of eye irritation studies according OECD-GHS-criteria
Substance: Decyl methacrylate, roh CAS: 3179 -47 -3
Internal No.: UNTER78 -016
Date/Expert: 10 -05 -2012/RG
Animal No. |
Corneal opacity/Hornhauttrübung[Scores] |
Mean Draize score |
Reversibility [scores] |
Hazard category |
||||
after 24 h |
after 48 h |
after 72 h |
in 7 days |
in 21 days |
||||
1, 2 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
||
3, 4 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
||
5, 6 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
||
none |
||||||||
Animal No. |
Iritis/Regenbogenhautentzündung[Scores] |
Mean Draize score |
Reversibility [scores] |
Hazard category |
||||
after 24 h |
after 48 h |
after 72 h |
in 7 days |
in 21 days |
||||
1, 2 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
||
3, 4 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
||
5, 6 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
||
none |
||||||||
Animal No. |
Conjunctiva redness (erythem) /Bindehautrötung[Scores] |
Mean Draize score |
Reversibility [scores] |
Hazard category |
||||
after 24 h |
after 48 h |
after 72 h |
in 7 days |
in 21 days |
||||
1, 2 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
||
3, 4 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
||
5, 6 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
||
none |
Animal No. |
Conjunctiva chemosis /Bindehautödem[Scores] |
Mean Draize score |
Reversibility [scores] |
Hazard category |
|||
after 24 h |
after 48 h |
after 72 h |
in 7 days |
in 21 days |
|||
1, 2 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
|
3, 4 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
|
5, 6 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
|
none |
Classification: Hazard Category |
none |
Classification Criteria for serious Eye Damage/Eye
Category 1
- Irreversible damage to cornea, iris, conjunctiva 21 days after exposure in at least one animal
- Mean Draize score in 2 of 3 canimals:
corneal opacity ≥3
iritis ≥ 1,5
Category 2
- Reversible adverse effects on cornea, iris, conjunctiva
- Mean Draize score in 2 of 3 animals:
corneal opacity >= 1
iritis >= 1
redness >= 2
chemosis >= 2
Subcategory 2A
- Reversible in 21 days
Subcategory 2B
- Reversible in 7 days
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Classification: not irritating
- Executive summary:
In a primary eye irritation study ( according to Appraisal of the Safety of Chemicals in foods, drugs and cosmetics, FDA Draize (1959)) 0.1 mL undiluted Decyl methacrylate, roh was instilled into the conjunctival sac of the left eye of 6 New Zealand White rabbits, (2.4 -2.6 kg body weight) for 72 hours (not rinsed). Animals were observed for 7 days. Irritation was scored according to Draize scoring and re-evalutated according OECD-GHS criteria.
In this study Decyl methacrylate, roh is not irritating to eyes.
OECD GHS Category: none
EU GHS Category: none
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