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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:
72-hour
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP study conducted according to generally accepted methods (OECD Guideline 405) for an eye irritation study. However, the purity of test material was not specified.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
Report did not contain purity information.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
-Name of test material (as cited in study report): 2,2,4-trimethylpentanediol-1,3-diisobutyrate; Texanol isobutyrate; TXIB
-Appearance: clear liquid
-Lot #: T-214
-Receipt at testing laboratory: 6/20/1990
-Source of test material: Eastman Chemical Company
-Storage conditions: room temperature and humidity

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS:
-Source: Hazleton Research Animals, Denver, PA
-Animals: 6 (sex not deterimined)
-Age: young adults, at least 3 months old
-Quarantine period: at least 5 days
-Weight at study initiation: body weights not recorded
-Housing: 1/cage in suspended steel mesh cages
-Bedding: placed beneath the cages and changed at least 3x/week
-Diet: Agway Prolab High Fiber Diet certified pellets, available ad libitum
-Water: available ad libitum
-Identification method: cage cards and uniquely numbered metal ear tag
-Method of Animal Distribution: no data

ENVIRONMENTAL CONDITIONS:
-Room temperature: 70 °F
-Relative humidity: 53-55%
-Lighting Cycle: 12 hours light/12 hours dark

IN-LIFE DATES:
-Date of exposure: 6-26-1990

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The remaining untreated eye of each rabbit served as a control.
Amount / concentration applied:
0.1 mL for one eye for each rabbit
Duration of treatment / exposure:
single dose
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6 (3 unwashed and 3 washed eyes)
Details on study design:
-Test material administration:
For each rabbit, the test material (0.1mL) was placed into the conjunctival sac of one eye. The remaining eye served as a control. After instillation, the lids were held together briefly to insure adequate distribution of the test material. Three of the eyes (rabbits 1-3) were immediately washed with running distilled water; the three remaining eyes (rabbits 4-6) were not irrigated.
-Observations:
The treated eye of each rabbit was examined for irritation of the cornea and adnexal structures, iris, and conjunctiva immediately after administration of the test material, and at 1, 24, 48, and 72 hours post dose. Ocular reactions were scored according to OECD Guideline 405 (Acute Eye Irritation/Corrosion). The eyes of all rabbits were examined for staining with sodium fluorescein at 24 hours. The general health of the rabbits was monitored at each observation time.
-Body weights:
not recorded

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
<= 1
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Grade 1 redness at 1-hour
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
<= 1
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Grade 1 redness at 1-hour
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
<= 1
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Grade 1 redness at 1-hour
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
<= 1
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Grade 1 redness at 1-hour
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The only irritant response evident in this study was slight redness for 1/3 unwashed eyes and 3/3 washed eyes at the 1-hour examinations.
Other effects:
There was no staining in unwashed or washed eyes when tested with fluorescein dye 24 hours after administration of the test substance. There were no abnormal systemic signs noted during the observation period.

Any other information on results incl. tables

CLINICAL OBSERVATIONS

Effects were graded according to OECD Guideline 405 (annex V Test B.5) for

corneal opacity (first #), iris (second #), redness (third #), chemosis (fourth #)

ANIMAL EFFECTS
# 1 HR 24 HR 48 HR 72 HR
UNWASHED EYES 1 0,0,1,0 0,0,0,0 0,0,0,0 0,0,0,0
2 0,0,0,0 0,0,0,0 0,0,0,0 0,0,0,0
3 0,0,0,0 0,0,0,0 0,0,0,0 0,0,0,0
WASHED EYES 4 0,0,1,0 0,0,0,0 0,0,0,0 0,0,0,0
5 0,0,1,0 0,0,0,0 0,0,0,0 0,0,0,0
6 0,0,1,0 0,0,0,0 0,0,0,0 0,0,0,0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The study showed that the test material is not irritating or corrosive to rabbit eyes. Signs of irritation were limited to slight redness at the 1-hour examinations and were fully reversible in 24 hours. Since no signs of irritation were noted at the 24-, 48-, or 72-hour examinations, 2,2,4-trimethylpentanediol-1,3-diisobutyrate was considered to be non-irritating to rabbit eyes, and therefore, presents a low irritation hazard upon eye contact under conditions of normal use.
Executive summary:

In a primary eye irritation study, six young adult New Zealand white rabbits (3 with unwashed eyes and 3 with washed eyes) were exposed to 0.1 mL of 2,2,4-trimethylpentanediol-1,3-diisobutyrate in one eye. Animals were then observed for 72-hours. Ocular reactions were graded according to OECD Guideline 405. The treated eyes of all rabbits were also examined with sodium fluorescein at 24 hours. The test material caused minimal eye irritation which was completely reversible by 24 hours. Since no signs of irritation were noted at the 24-, 48-, or 72 hour examinations, 2,2,4-trimethylpentanediol-1,3-diisobutyrate is not considered an eye irritant in this study using the OECD GHS classification system.