Registration Dossier

Administrative data

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

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 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

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

Results and discussion

In vivo

Resultsopen allclose all
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

Applicant's summary and conclusion

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.