Bis(2-ethylhexyl) maleate

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:

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

Test material information

Constituent 1

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

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

Results

Results 1

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

Results 2

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

Results 3

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 5

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

Results 6

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

Results 7

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 8

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 9

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

Results 10

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

Results 11

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 12

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.