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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
27 Oct 1997 - 30 Oct 1997
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted generally according to an accepted and published method. Experimental documentation was limited but adequate for the purposes of this summary.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997
Reference Type:
secondary source
Title:
EPA High Production Volume Chemical Challenge Program CAS 141-17-3 adipic acid, bis[2-(2-butoxyethoxy)ethyl] ester
Author:
US EPA
Year:
2011
Bibliographic source:
High Production Volume Chemical Challenge Program

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OTS 798.4500 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Bis(2-(2-butoxyethoxy)ethyl) adipate
EC Number:
205-465-5
EC Name:
Bis(2-(2-butoxyethoxy)ethyl) adipate
Cas Number:
141-17-3
Molecular formula:
C22H42O8
IUPAC Name:
bis(2-(2-butoxyethoxy)ethyl) adipate

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS- Source: Davidson Mill Breeding Laboratories, Jamesburg, New Jersey, USA- Ag at arrival: 3 months- Fasting period before study: none- Housing: stainless steel cages- Diet: Lab Diet Certified Rabbit Diet #5322, ad libitum- Water: ad libitum- Acclimation period: 5 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 18 - 24 (65 - 75 °F)- Photoperiod (hrs dark / hrs light): 12/12IN-LIFE DATES: From: To: 27 Oct 1997 - 30 Oct 1997

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the other eye remained untreated and served as control
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
Single administration without washing
Observation period (in vivo):
72 hoursReading time points: 1, 24, 48, and 72 h after treatment
Number of animals or in vitro replicates:
6 (3 male, 3 female)
Details on study design:
SCORING SYSTEM: Draize Scoring SystemTOOL USED TO ASSESS SCORE: fluorescein, hand-held ophthalmoscope

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
over all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
over all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
over all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
over all 6 animals
Time point:
other: mean over 24, 48, and 72 hours
Score:
0.22
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility: not applicable

Any other information on results incl. tables

Table 1: Primary ocular irritiation in rabbits - Summary

Rabbit number

Bodyweight [kg]

Reading time [h]

Cornea

Iris

Conjunctivae

Score

Area

Redness

Chemosis

Discharge

1

Init: 1.96

1

0

0

0

1

1

1

-

24

0

0

0

1

0

0

-

48

0

0

0

0

0

0

Term: 1.86

72

0

0

0

0

0

0

2

Init: 1.97

1

0

0

0

1

1

1

-

24

0

0

0

1

0

0

-

48

0

0

0

0

0

0

Term: 1.87

72

0

0

0

0

0

0

3

Init: 1.86

1

0

0

0

1

1

1

-

24

0

0

0

1

0

0

-

48

0

0

0

0

0

0

Term: 1.76

72

0

0

0

0

0

0

4

Init: 1.99

1

0

0

0

1

0

1

-

24

0

0

0

1

0

0

-

48

0

0

0

0

0

0

Term: 1.89

72

0

0

0

0

0

0

5

Init: 1.88

1

0

0

0

1

1

1

-

24

0

0

0

0

0

0

-

48

0

0

0

0

0

0

Term: 1.79

72

0

0

0

0

0

0

6

Init: 2.0

1

0

0

0

1

1

1

-

24

0

0

0

0

0

0

-

48

0

0

0

0

0

0

Term: 1.96

72

0

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
CLP: not classifiedDSD: not classified

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