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EC number: 219-529-5 | CAS number: 2455-24-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test procedure according to national (US) standards comparable to international guidelines. Pre-GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Appraisal of the safety of chemicals in foods, druge and cosmetics, by the Staft of the Division of Pharmacology, US FDA, Bewertung von Augen-Läsionen nach Draize (1959)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: US FHSA Federal regulation: 16 CFR 1500.42
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
- Remarks:
- study performed before implementation of GLP
Test material
- Reference substance name:
- Tetrahydrofurfuryl methacrylate
- EC Number:
- 219-529-5
- EC Name:
- Tetrahydrofurfuryl methacrylate
- Cas Number:
- 2455-24-5
- Molecular formula:
- C9H14O3
- IUPAC Name:
- (oxolan-2-yl)methyl 2-methylprop-2-enoate
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Tetrahydrofurfurylmethacrylat
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 to 2.6 kg
- Housing: individually
- Diet (e.g. ad libitum): standard diet, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±1°C
- Humidity (%): 45 to 55%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light):12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated right eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): undiluted, as supplied - Duration of treatment / exposure:
- eys were not rinsed after application
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): eyes were not rinsed for substance removal after treatment
SCORING SYSTEM: Draize scale
TOOL USED TO ASSESS SCORE: no data
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2, #3, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal: #4, #5
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 7
- Reversibility:
- fully reversible within: 72 h
- Irritant / corrosive response data:
- Transient conjunctival redness grade 1 (some blood vessels hyperaemic (injected)) to 2 (diffuse, crimson colour; individual vessels not easily discernible) was seen up to 72 h after application in 5/6 animals. Chemosis grade 1 (some swelling above normal) was observed in 2/6 animals. All other animals showed no reactions. All effects were completely reversible within 4 days.
- Other effects:
- no other effects reported
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
- Conclusions:
- In this study, THFMA is not an eye irritant.
- Executive summary:
In a primary eye irritation study similar to US FHSA Federal regulation: 16 CFR 1500.42 (similar to OECD guideline 405),
0.1 mL of THFMA (according to sponsor's information purity ca. 98%) was instilled into the conjunctival sac of the left eye of 6 New Zealand White rabbits without removing the test substance. Animals then were observed for 7 days. Irritation was scored by the method of Draize.
Transient conjunctival redness grade 1 (some blood vessels hyperaemic (injected)) to 2 (diffuse, crimson colour; individual vessels not easily discernible) was seen up to 72 h after application in 5/6 animals. Chemosis grade 1 (some swelling above normal) was observed in 2/6 animals. All other animals showed no reactions. All effects were completely reversible within 4 days. No irritating effects to the cornea and iris have been observed.
In this study, THFMA is not an eye irritant.
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