Registration Dossier

Administrative data

Description of key information

DEGDBE is not skin irritating and not eye irritating. 

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
New Zealand White
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
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

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
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002-02-06 to 2002-04-09
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Scientifically well performed study; Guideline study; GLP study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
24h
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1d,2d,3d
Score:
0.11
Max. score:
1
Reversibility:
fully reversible within: 7d
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1d,2d,3d
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1d,2d,3d
Score:
0.56
Max. score:
2
Reversibility:
fully reversible within: 7d
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1d,2d,3d
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 7d
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
DEGDBE was investigated for its eye irritation potential according to OECD 405. DEGDBE is not irritating to eyes.
Executive summary:

DEGDBE was investigated for its eye irritation potential according to OECD 405.

One hour after administration the conjuctivae of all animals showed definitely injected blood vessels. Furthermore, one animal showed definitely injected blood vessels up to a crimson red color and slight swellings 24 hours up to 72 hours after adiminstration. Diffuse areas of opacity of the cornea were observed 24 hours after adiminstration. In the fluoresceine test 24 hours after administration staining areas were observe in this animal. In addition ot these observations, clear-colorless serous eye discharge was noted in all animals. 7 days after administration all signs of irriation had disappeared.

DEGDBE is not irritating to eyes.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
Scientifically well performed study; Guideline study; GLP study

Justification for selection of eye irritation endpoint:
Scientifically well performed study; Guideline study; GLP study

Justification for classification or non-classification

The skin and eye irritation potential of DEGDBE was investigated according to OECD Guideline 404 and 405 respectively. Based on the results of these studies, no classificaiton is warranted.