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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:
8 -12 Jan 2008
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Deviations: no initial test using one animal performed; no use of topical anesthetics and systemic analgesics

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted 9 October 2017
Deviations:
yes
Remarks:
no initial test using one animal performed; no use of topical anesthetics and systemic analgesics
GLP compliance:
yes

Test material

1
Chemical structure
Reference substance name:
1-{[1-({1-[(2,2-dimethylpropanoyl)oxy]propan-2-yl}oxy)propan-2-yl]oxy}propan-2-yl 2,2-dimethylpropanoate
Molecular formula:
C19H36O6
IUPAC Name:
1-{[1-({1-[(2,2-dimethylpropanoyl)oxy]propan-2-yl}oxy)propan-2-yl]oxy}propan-2-yl 2,2-dimethylpropanoate

Test animals / tissue source

Species:
rabbit
Strain:
other: Jla:JW
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Japan Laboratory Animals Inc.
- Age at study initiation: 15 weeks
- Weight at study initiation: 2.49 to 2.78 kg for 100% test article formulation group and 2.60 to 2.78 kg for 10% test article formulation group
- Housing: individual housed in aluminum cages with wire mesh bottoms
- Diet: RC4 pelleted diet (Oriental Yeast Co., Ltd., Lot No. 080916), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 5
- Humidity (%): 55 ± 25
- Air changes (per hr): 11 - 14
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 8 Jan 2009 To: 12 Jan 2009

Test system

Vehicle:
other: liquid paraffine
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL
- Concentration: 10 and 100% (w/w)

VEHICLE
- Lot/batch no.: PEK3961 (Wako Pure Chemical Industries, Co., Ltd.)
Duration of treatment / exposure:
After application of test material eyelids were gently held together for about 1 second in order to prevent loss of the test article formulation
Observation period (in vivo):
1, 24, 48, 72 and 96 h after application
Number of animals or in vitro replicates:
3 per dose group
Details on study design:
SCORING SYSTEM: Draize scoring system and Kay and Calandra method

TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein / photographs

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
100% test material
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
iris score
Remarks:
100% test material
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Remarks:
100% test material
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility: not applicable
Irritation parameter:
chemosis score
Remarks:
100% test material
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
cornea opacity score
Remarks:
10% test material in liquid paraffine
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other:
Remarks:
reversibility: not applicable
Irritation parameter:
iris score
Remarks:
10% test material in liquid paraffine
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other:
Remarks:
reversibility: not applicable
Irritation parameter:
conjunctivae score
Remarks:
10% test material in liquid paraffine
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other:
Remarks:
reversibility: not applicable
Irritation parameter:
chemosis score
Remarks:
10% test material in liquid paraffine
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: bot applicable
Irritant / corrosive response data:
In the 100% test article formulation group, conjunctival redness (score 1) and discharge (score 1) were observed in all and 1/3 animals, respectively, at 1 h after application. In the 10% test article formulation group, conjunctival redness (score 1) and discharge (score 1) were observed in all animals at 1 h after application. However, these conjunctival changes in both groups had disappeared completely at 24 h after application. There were no abnormalities in the cornea or iris, and no other ocular changes were observed in either group.
Other effects:
- Other observations: No abnormal clinical signs or abnormalities on body weight were observed in any animal of either group during the observation period.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008
Conclusions:
Under the conditions of the performed test, the test substance does not meet the classification criteria according to Regulation(EC) No. 1272/2008.