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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:
From Dec. 02, 2009 to Dec. 24, 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was conducted according to OECD Test Guideline 405, in compliance with GLP. The test substance characterization, provided by the sponsor, was not conducted according to the Good Laboratory Practices. However, it was approved under ISO 9001: 2008 .

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Remarks:
The test substance characterization, provided by the sponsor, was not conducted according to the Good Laboratory Practices. However, it was approved under ISO 9001: 2008 .

Test material

Constituent 1
Chemical structure
Reference substance name:
Trioctylphosphine oxide
EC Number:
201-121-3
EC Name:
Trioctylphosphine oxide
Cas Number:
78-50-2
Molecular formula:
C24H51OP
IUPAC Name:
trioctylphosphine oxide
Test material form:
other: Solid
Details on test material:
- Name of test material (as cited in study report): CYANEX® 921 Extractant
- Physical state: white solid
- Analytical purity: 90%
- Lot/batch No.: WE7060753
-Certificate of analysis: CYANEX921 dated 01-Dec-2009
- Storage condition of test substance: at room temperature and humidity.
-Expiration date of the lot/batch: 6 months from date of receipt
- Date of receipt: 04 Dec, 2009

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Source: Covance Research Products Inc., Denver. PA
Housing: the animals were housed 1/cage in suspended cages. Paper bedding was placed beneath the cages and changed at least three times/week.
Body weight range before the test: 2.9-3.1 kg
Diet: fresh PMI Rabbit Chow (Diet #5321)
Water: ad libitum
Photoperiod: 12 h light/dark cycle

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The contralateral eye served as a control.
Amount / concentration applied:
61.3 mg (equivalent to 0.1 mL)
Observation period (in vivo):
1, 24, 48 and 72 h following administration of the test substance.
Number of animals or in vitro replicates:
3
Details on study design:
0.1 mL of test substance was instilled into one eye of each animal. Contralateral eye served as a control. Using a Mini-Maglite flashlight equipped with a high intensity bulb, the treated and control eye of each rabbit was examined for irritation of the cornea, iris and conjunctiva at 1, 24, 48 and 72 h following administration of test substance. Sodium fluorescein dye procedures were used at the 24 h observation interval. The eye was examined with the aid of an ultraviolet light source. Ocular reactions were graded according to the numerical Draize technique.

Body weights were recorded pretest and at termination.

Observations for toxicity and pharmacological effects were recorded at each ocular observation period and mortality observations were performed daily. All animals were humanely sacrificed using CO2 following study termination

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Remarks:
(mean score)
Time point:
other: Overall at 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Remarks:
redenss
Basis:
animal #2
Remarks:
(mean score)
Time point:
other: Overall at 24, 48 and 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Remarks:
(mean score)
Time point:
other: Overall at 24, 48 and 72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(mean score)
Time point:
other: Overall at 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score)
Time point:
other: Overall at 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score)
Time point:
other: Overall at 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(mean score)
Time point:
other: Overall at 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean score)
Time point:
other: Overall at 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean score)
Time point:
other: Overall at 24, 48 and 72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
There was no corneal opacity or iritis noted at any observation period. Conjunctival irritation. noted in 3/3 eyes. cleared in one eye by 24 h and in two eyes by 72 h.
Other effects:
No clinical signs of systemic toxicity were observed. Body weights were also normal.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance produced mild eye irritation (Hall DA, 2010).
Executive summary:

A study was conducted to evaluate the eye irritation potential of the test substance in rabbits according to OECD Guideline 405, in compliance with GLP. Test substance (0.1 mL, which is equivalent to 61.3 mg) was instilled in one eye of three New Zealand White rabbits with the help of a syringe-type applicator. The contralateral eye served as control. The treated and control eyes of each rabbit were examined for irritation of the cornea, iris and conjunctiva at 1, 24, 48 and 72 h following instillation of the test substance. The eye was examined with the aid of an ultraviolet light source. Ocular reactions were graded according to the numerical Draize technique. Toxicity and pharmacological effects were recorded at each ocular observation period and mortality was checked daily. All animals were humanely sacrificed using C02following study termination. There was no corneal opacity or iritis noted at any observation period. Conjunctival irritation, seen all animals, cleared in one eye by 24 h and in the other two by 72 h. The control eyes appeared normal at all observation periods. No abnormal physical signs were recorded. Under the study conditions, the test substance was not irritating to eyes (Hall DA, 2010).