Registration Dossier

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:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 1d,2d,3d
Score:
1.67
Max. score:
2
Reversibility:
fully reversible within: 14days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1d,2d,3d
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 14 days
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
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
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
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.