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EC number: 210-848-5 | CAS number: 624-48-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- no GLP, analytical purity not reported, only few information on animal environmental conditions
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- no GLP, analytical purity not reported, only few information on animal environmental conditions.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Dimethyl maleate
- EC Number:
- 210-848-5
- EC Name:
- Dimethyl maleate
- Cas Number:
- 624-48-6
- Molecular formula:
- C6H8O4
- IUPAC Name:
- dimethyl (Z)-but-2-enedioate
- Details on test material:
- - Name of test material (as cited in study report): maleic acid dimethylester.
- Physical state: liquid.
- Analytical purity: not reported.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hacking& Churchill Ltd., Huntingdon, UK.
- Housing: single housing in standard conventional cages.
- Diet (e.g. ad libitum): Standard diet ( “Ssniff K4” Versuchstierdiäten GmbH, Soest/Westfalen) ad libitum.
- Water (e.g. ad libitum): ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 °C.
- Humidity (%): 40-60%.
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye served as control
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 7 d
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- After application, the eye lids were held together for approximately 1 second.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with NaCl phisiological solution.
- Time after start of exposure: 24 hours after application.
SCORING SYSTEM: Draize.
TOOL USED TO ASSESS SCORE: fluorescein.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- All animals showed slight corneal opacity after application, slight iritis, partially scaled pupil, as well as slight redness and swelling of the conjunctiva with lacrimation. 7 days after application none of the mentioned symptoms were observed anymore and no change from the normal physiological findings was recorded in the eyes.
Any other information on results incl. tables
Table 1: Results of eye irritation test
Conjunctiva |
|||||
Rabbit No./ sex |
Scoring [h] |
Cornea |
Iris |
Redness |
Chemosis |
42/male |
1 | 2 | 1 | 2 | 3 |
| 24 | 2 | 1 | 3 | 2 | |
| 48 | 2 | 0 | 2 | 1 | |
| 72 | 1 | 0 | 1 | 0 | |
| 168 | 0 | 0 | 0 | 0 | |
Mean (24, 48, 72 h) |
1.7 | 0.3 | 2 | 1 | |
43/male |
1 | 1 | 1 | 2 | 2 |
| 24 | 1 | 1 | 3 | 1 | |
| 48 | 1 | 0 | 1 | 1 | |
| 72 | 1 | 0 | 1 | 0 | |
| 168 | 0 | 0 | 0 | 0 | |
Mean (24, 48, 72 h) |
1 |
0.3 |
1.7 | 0.7 | |
44/male |
1 | 1 | 1 | 2 | 2 |
| 24 | 1 | 0 | 2 | 1 | |
| 48 | 1 | 0 | 1 | 1 | |
| 72 | 1 | 0 | 1 | 0 | |
| 168 | 0 | 0 | 0 | 0 | |
Mean (24, 48, 72 h) |
1 | 0 | 1.3 | 0.7 | |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2B (mildly irritating to eyes) based on GHS criteria
- Conclusions:
- Based on the study results, dimethyl maleate is is classified as Category 2B (mildly irritating to eyes) according to UN-GHS regulation and classificed as Category 2 according to EU-CLP.
- Executive summary:
Suberg (1985)
In an eye irritation study, 0.1 mL of undiluted dimethyl maleate was instilled into the conjunctival sac of one eye of three male New Zealand White rabbits. Animals were observed for 7 days. Irritation was scored according to the method of Draize. All animals showed slight corneal opacity after application, slight iritis, partially scaled pupil, as well as slight redness and swelling of the conjunctiva with lacrimation. 7 days after application none of the mentioned symptoms were observed anymore and no change from the normal physiological findings was recorded in the eyes. Based on the study results, dimethyl maleate is is classified as Category 2B (mildly irritating to eyes) according to UN-GHS regulation and classificed as Category 2 according to EU-CLP.
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