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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test conducted according to OECD guideline 405

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not applicable
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Dibutyl maleate
EC Number:
203-328-4
EC Name:
Dibutyl maleate
Cas Number:
105-76-0
Molecular formula:
C12H20O4
IUPAC Name:
dibutyl but-2-enedioate
Details on test material:
Batch Number: FASS 859 vom 24.02.98; Maleic acid and fumaric acid dibutyl ester min. 98.5 wt %; clear colourless liquid

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Source - Commercial supplier
Weight at study - 2.7 to 3.2 kg
Age - at least 14 weeks old
Acclimation - a period of 35 days prior to the start of the study.
Housing - individually in metal cages
Diet - standard laboratory rabbit diet (Special Diet Services STANRAB (P) SQC pellet ad libitum
Drinking - potable water ad libitum
Test - routine physical and chemical examination of drinking water was conducted
Animal room temperature was maintaned at 15 to 16 Celsius degree and relative humidity at 38 to 48%. These parameters were recorded daily.
Lighting - available 12 hours period (07:00 - 19:00 hours) in each 24 hours
ID - each animal was identified by animal stock number and ear tattoo.


Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
A volume of 0.1 ml of the test substance was placed in the lower everted lid of one eye of animal.
Number of animals or in vitro replicates:
three

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: one hour after application
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: one hour after application
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: one hour after application
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: One hour after application
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 24 hours
Irritant / corrosive response data:
A diffuse, crimson colouration of the conjunctiva with/without slight swelling was observed in all three animals. These reactions were resolved by one or two day post application.

Any other information on results incl. tables

.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Dibutyl maleate was a well-defined conjunctival irritant.
Executive summary:

The potetial for dibutyl maleate was assessed according to the OECD guideline 405 in an acute eye irritation/corrosion test. The test substance was administered in a single ocular dose of a volume of 0.1 ml and observed for three days. No corneal damage or iridial inflammation was observed. Dibutyl maleate is a well-defined conjunctival irritant only with a recovery period of one or two days after application.