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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:
2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
Principles of method if other than guideline:
not applicable
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
5471-76-3
IUPAC Name:
5471-76-3
Constituent 2
Chemical structure
Reference substance name:
2-butoxyethyl benzoate
EC Number:
226-685-8
EC Name:
2-butoxyethyl benzoate
Cas Number:
5451-76-3
Molecular formula:
C13H18O3
IUPAC Name:
2-butoxyethyl benzoate
Test material form:
other: variable coloured liquid
Details on test material:
- Name of test material (as cited in study report): Butyl Cellosolve™ Benzoate
- Physical state: variable coloured liquid
- Analytical purity: 99.86%
- Lot/batch No.: 02112012-JLT
- Expiration date of the lot/batch: 11 February 2013
- Storage condition of test material: Ambient (+18 to +36 ºC)
Specific details on test material used for the study:
Batch Manufactured and Supplied By: The Dow Chemical Company, Midland, MI, 48674, USA
Chemical Name : 2-Butoxy-ethanol benzoate
Physical Description (color + physical state): Variable coloured liquid
Purity : 99.86%
Lot No. : 02112012-JLT
pH : 6.08 (1% aqueous solution analyzed at Advinus under study no. G8567)

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: inhouse bred (outbred)
- Age at study initiation: 7-8 months
- Weight at study initiation: 2.8 - 2.94 kg
- Housing: The rabbits were housed individually in rabbit cages (approx. size: L 65 x B 65 xH 45 cm) under standard laboratory conditions
- Diet (ad libitum): The animals were offered rabbit feed manufactured by Pranav Agro Industries Ltd, Sangli, Maharashtra, India.
- Water (ad libitum): The animals were provided deep bore-well water passed through activated charcoal filter and exposed to UV rays in Aquaguard on-line water filter-cum-purifier. The water was replenished once daily and the water bottles changed once a week.
- Acclimation period: 5-6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22°C
- Humidity (%): 56-65%
- Air changes (per hr): 12-15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark cycle

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
A volume of 0.1 mL of the undiluted test substance was instilled into the eye of the rabbits.
Duration of treatment / exposure:
A volume of 0.1 mL of the test substance was placed in the everted lower lid (conjunctival sac) of the left eye of each of three rabbits. The eye lids were gently held together for about one second, in order to minimize loss of the test substance.
Observation period (in vivo):
1, 24, 48 and 72 hours post instillation.
Number of animals or in vitro replicates:
3 male rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: A volume of 0.1 mL of the test substance was placed in the everted lower lid (conjunctival sac) of the left eye of each of three rabbits. The eye lids were gently held together for about one second, in order to minimize loss of the test substance. The right eye of each rabbit remained untreated and served as the reference control.

SCORING SYSTEM: The eyes were evaluated with the illumination of a white light source at intervals of approximately 1, 24, 48 and 72 hours post instillation of the test substance according to the "Scale for Scoring Ocular Lesions" (Draize, 1944).

TOOL USED TO ASSESS SCORE: The fluorescein dye evaluation procedure was used for the treated eyes at 24 hours post instillation of the test substance to verify the extent or absence of corneal damage.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
RB9666
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
RB9666
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
RB9666
Time point:
24/48/72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
RB9666
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
RB9667
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
RB9667
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
RB9667
Time point:
24/48/72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
RB9667
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
RB9668
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
RB9668
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
RB9668
Time point:
24/48/72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
RB9668
Time point:
24/48/72 h
Score:
0
Irritant / corrosive response data:
Eye Reactions:
There was no eye irritation (iritis, conjunctival irritation or corneal opacity) observed in any treated eye during the study at 1, 24, 48 and 72 hours post instillation.
After the completion of the study the animals were released for euthanasia and humanely euthanized.
Other effects:
Clinical Observations:
There were no clinical signs of toxicity or mortality observed during the study.

Body Weights:
The body weights of all rabbits increased slightly throughout the observation period.

Any other information on results incl. tables

The individually determined mean irritation scores for each animal for corneal opacity, iris lesion, conjunctival redness and conjunctival chemosis for the 24-, 48- and 72-hour intervals are:

 

Animal No.

(Sex)

Corneal

Opacity

Iris Lesion

Conjunctival

Redness

Conjunctival

Chemosis

RB9666 (M)

0

0

0

0

RB9667 (M)

0

0

0

0

RB9668 (M)

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study, 2-butoxyethyl benzoate did not cause any eye irritation.
Executive summary:

An acute eye irritation / corrosion study in rabbits was conducted to evaluate the eye irritation potential of 2-butoxyethyl benzoate. Under the conditions of this study, 2-butoxyethyl benzoate did not cause any eye irritation.

The test was performed in a stepwise manner. A single rabbit was initially exposed to the test substance. Since the test substance was not corrosive or severely irritating, the study was completed using two additional rabbits.

A quantity of 0.1 mL of the test substance was placed in the everted lower lid (conjunctival sac) of the left eye of each of three rabbits. The lids were gently held together for about one second, in order to minimize loss of the test substance. The right eye of each rabbit remained untreated and served as the reference control. The eyes were evaluated at 1, 24, 48 and 72 hours post instillation according to the scale for scoring ocular lesions (DRAIZE, 1944). There were no clinical signs of toxicity or mortality. All rabbits appeared healthy and gained body weight

throughout the observation period.

There was no eye irritation (iritis, conjunctival irritation or corneal opacity) observed in any treated eye during the study at 1, 24, 48 and 72 hours post instillation.