Dibutyl maleate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Test conducted according to OECD guideline 404

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

not applicable

GLP compliance:

yes

Test material

Test material information

Constituent 1

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:

Dibutyl maleate
clear colourless liquid
Batch #: FASS 859 vom 24.02.98
Expiration date: 1 Nov 1999
Purity: 98.5%

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Source - Commercial supplier
Weight at study - 2.2 to 2.6 kg
Age - at least 11 weeks old
Acclimation - a period of five days prior to the start of the study.
Housing - individually in stainless steel cages
Diet - standard laboratory rabbit diet 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 57%. These parameters were recorded daily.
Lighting - available 12 hours period in each 24 hours

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Duration of treatment / exposure:

Rabbits were each administered a single dermal dose of 0.5 ml of DBM.

Observation period:

Rabbits were observed for up to eight days.

Number of animals:

Three

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 5 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 72h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 8 days

Irritant / corrosive response data:

Well-defined erythema was observed in rabbit # 1 and very slight erythema in rabbits #2 and 3. The rabbits were gradually recovered by day 5, 7 and 8, respectively.

Any other information on results incl. tables

Dermal Reactions

Rabbit No/Sex	E=Erythema O= Oedema	Day
		1	2	3	4	5	6	7	8
1627/Female	E	0	2	2	1	1	1	0
	O	0	0	0	0	0	0	0	0
1628/Female	E	0	1	1	1	0
	O	0	0	0	0	0
1637/Female	E	0	1	1	1	1	1	1	0
	O	0	0	0	0	0	0	0	0

* Approximately 60 minutes after removal of the dressing

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Dibutyl maleic is slightly irritant to the skin.

Executive summary:

The potential for DBM was assessed according to the OECD guideline 404 in an acute dermal irritation/corrosion test. The test substance was administered in a single dermal dose of 0.5 ml and observed for eight days. The reaction in all three animals were resolved by Day 5, 7,and 8 respectively. DBM was determined to be slightly irritating in all three rabbits during the observation period. One animal showed a well-defined dermal irritanting response on days 2 -3 only. Based on the results, it was concluded that DBM is a slightly to well defined irritating to the skin.

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