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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:
February 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
yes
Remarks:
Humdidity was outside protocol range but did not affect study outcome.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Alkenes, C11-12, hydroformylation products, distn. residues, Alchisor CAL (Commercial Name)
- Substance type: pure active substance
- Physical state: colourless liquid
- Storage condition of test material: at room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Nichols Rabbitry Inc., Lumberton, TX, USA
- Age at study initiation: approx. 3 month
- Weight at study initiation: 2.03 - 2.20 kg
- Housing: in suspended, wire-bottomed, stainless steel cages, 1 animal per cage
- Diet (e.g. ad libitum): Lab Rabbit Diet #5321 (PMI Feeds Inc.), approx. 8 oz. per day
- Water (e.g. ad libitum): Municipal water ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
- Humidity (%): 24-46 (outside protocol range)
- Air changes (per hr): 10 - 12
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 2010-02-15 To: 2010-02-18

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as comparative control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
1, 24, 48 and 72 hours after test substance administration
Number of animals or in vitro replicates:
3 (1 male, 2 females)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): all treated eyes were washed out with room temperature deionized water for one minute
- Time after start of exposure: immediately after recording the 24-hour observation


SCORING SYSTEM:
according to Draize, John H., Woodward, Geoffrey, and Calvery, Herbert O., Journal of Pharmacol. Exp. Ther., 82, 377-390 (1944)


TOOL USED TO ASSESS SCORE: The treated eyes of all animals were examined without magnification under white room lighting provided by daylight-type fluorescent ceiling fixtures, and an additional source of white light affixed to the examination table or using a handheld flashlight.
After the 24-hour observation the corneas of all treated eyes were examined with a fluorescein sodium ophthalmic solution. A finoff ocular transilluminator with cobalt blue filter was utilized to enhance visualization of fluorescein staining.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0.11
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0.44
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritant / corrosive response data:
see table below
Other effects:
none

Any other information on results incl. tables

Table #1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility

Cornea

Iris

Conjunctivae

Chemosis

Max. score: 4

Max. score: 2

Max. score: 3

Max. score: 4

60 min

+/0/0

 1/0/0

 1/1/1

 1/1/1

24 h

 0/0/0

 1/0/0

 1/1/1

 1/1/0

48 h

 0/0/0

 0/0/0

 1/1/1

 1/1/0

72 h

 0/0/0

 0/0/0

 0/0/0

 0/0/0

Average 24h, 48h, 72h

 0

 0.11

 0.67

 0.44

Area effected

 1

 

 

 

Reversibility*)

 -

 c.

 c.

 c.

Average time (unit) for reversion

 -

 48 h

 72 h

 72 h

 + = slight dulling of normal luster

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the maximum average irritation score of 10.3, obtained 1 hour after treatment, the test substance was rated minimally irritating. Fluorescein staining did not occur in any of the eyes.
Executive summary:

An acute eye irritation study was conducted on three albino rabbits using test substance Alkenes, C11 -12, hydroformylation products, distn. residues (CAS No: 90622 -27 -8). 0.1 mL of the test substance was placed into the conjunctival sac of the right eye of each animal selected for testing. All treated eyes were washed with room temperature deionized water for one minute immediately after recording the 24-hour observation. There were no positive effects exhibited in any eyes at 48 hours after treatment. Non-positive irritation was clear by 72 hours, and the test substance was rated minimally irritating.