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EC number: 205-524-5 | CAS number: 142-16-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994-02-28 to 1994-04-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Bis(2-ethylhexyl) maleate
- EC Number:
- 205-524-5
- EC Name:
- Bis(2-ethylhexyl) maleate
- Cas Number:
- 142-16-5
- Molecular formula:
- C20H36O4
- IUPAC Name:
- bis(2-ethylhexyl) but-2-enedioate
- Reference substance name:
- Dioctyl maleate
- EC Number:
- 220-835-6
- EC Name:
- Dioctyl maleate
- Cas Number:
- 2915-53-9
- Molecular formula:
- C20H36O4
- IUPAC Name:
- dioctyl but-2-enedioate
- Details on test material:
- - Name of test material (as cited in study report): Dioctylmaleinat
- Chemical name: (Z)-2-Butendisäure-bis-(2ethyl)ester
- Substance type: active substance
- Physical state: colourless - yellow liquid
- Analytical purity: 96.1%
- Lot/batch No.: Ch 35559, Beh. 828
- Expiration date of the lot/batch: August 1994
- Storage condition of test material: in a closed vessel in the flue
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach an der Riss, Germany
- Age at study initiation: adult
- Weight at study initiation: 2.6 kg
- Sex: male
- Housing: individual housing
- Diet: Ssniff K 4 - Alleindiät for rabbits ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 30 - 70%
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 cm³
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 1, 24, 48, and 72 hours after application.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): eyes were washed with physiological saline
- Time after start of exposure: 24 hours
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Other effects:
- Animal #1 showed a slight exsudation 1 hour after application.
Any other information on results incl. tables
Table 1:Irritant response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
|
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
60 min |
0/0/0 |
0/0/0 |
1/1/1 |
1/1/1 |
24 h |
0/0/1 |
0/0/0 |
1/1/1 |
1/1/1 |
48 h |
0/0/0 |
0/0/0 |
1/0/1 |
0/0/0 |
72 h |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
Average 24h, 48h, 72h |
0/0/0.33 |
0/0/0 |
0.67/0.33/0.67 |
0.33/0.33/0.33 |
Reversibility*) |
c |
c |
c |
c |
Average time (unit) for reversion |
72 h |
72 h |
72 h |
72 h |
*) Reversibility: c. = completely reversible;= not completely reversible; n. = not reversible
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on only slight and reversible effects, dioctyl maleate is not an eye irritant.
- Executive summary:
In a primary eye irritation study, 0.1 cm³ of pure, undiluted dioctylmaleinate was instilled into the conjunctival sac of one eye of adult male Himalayan rabbits. Three animals were used for the test. 24 hours after application, eyes were washed with physiological saline. Animals were observed for 3 days. Irritation was scored by the method of Draize.
Only slight effects were observed which were reversible within 72 hours. Based on these observations, dioctyl maleate was not an eye irritant.
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