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Toxicological information

Eye irritation

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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:
1994
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

Constituent 1
Chemical structure
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
Constituent 2
Chemical structure
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

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.