Bis(2-butoxyethyl) ether

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2002-02-04 to 2002-03-11

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Scientifically well performed; Guideliine study; GLP study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Bis(2-butoxyethyl) ether

EC Number:

204-001-9

EC Name:

Bis(2-butoxyethyl) ether

Cas Number:

112-73-2

Molecular formula:

C12H26O3

IUPAC Name:

1-[2-(2-butoxyethoxy)ethoxy]butane

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

Amoung applied: 0.5 ml Diethylenegylkoldibutylether

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 1d,2d,3d

Score:

1.67

Max. score:

2

Reversibility:

fully reversible within: 14days

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 1d,2d,3d

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 14 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 1d,2d,3d

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 14 days

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 1d,2d,3d

Score:

0.67

Max. score:

2

Reversibility:

fully reversible within: 14 days

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 1d,2d,3d

Score:

1.67

Max. score:

2

Reversibility:

fully reversible within: 14 days

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 1d,2d,3d

Score:

0.67

Max. score:

2

Reversibility:

fully reversible within: 14 days

Any other information on results incl. tables

Observations:

24 hours up to 7 days after removal of the plaster the animals showed very slight up to well-defined erythema and 48 hours up to 7 days very slight up to well-defined oedema. Additionally, the skin surface of all animals was dry-rought, and of one animal was coarse scaled, too. 14 days after adiministration all signs of irritation were reversible.

Individual Scores

Animal	Reading Time	Erythema	Oedema
Animal #1	1h	0	0
	1d	1	0
	2d	2	1
	3d	2	2
	7d	2	1
	14d	0	0
Animal #2	1h	0	0
	1d	0	0
	2d	0	0
	3d	1	2
	7d	1	2
	14d	0	0
Animal #3	1h	0	0
	1d	1	0
	2d	2	0
	3d	2	2
	7d	2	1
	14d	0	0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

DEGDBE was tested for its skin irritation potential according to the OECD Guideline 404. No classification is warranted.

Executive summary:

DEGDBE was tested for its skin irritaiton potential according to the OECD Guideline 404.

24 hours up to 7 days after removal of the plaster the animals showed very slight up to well-defined erythema and 48 hours up to 7 days very slight up to well-defined oedema. Additionally, the skin surface of all animals was dry-rought, and of one animal was coarse scaled, too. 14 days after adiministration all signs of irritation were reversible.

Based on the obtained result, DEGDBE is not skin irritating.