Oils, animal, sulfonated, sodium salts

Eye irritation

Administrative data

Endpoint:

eye irritation

Remarks:

other: ex-vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

08 April 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study according to well-documented and supported procedures for which no guideline (OECD, etc.) exists

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

The ocular irritancy potential of the test material was assessed after application onto the cornea of an enucleated rabbit eye.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Oils, lard, oxidized, sulfited, sodium salts

EC Number:

297-185-5

EC Name:

Oils, lard, oxidized, sulfited, sodium salts

Cas Number:

93348-42-6

IUPAC Name:

93348-42-6

Details on test material:

- Name of test material (as cited in study report): FLL sample 6
- Chemical name: oils, lard, oxidized, sulfited, sodium salts (triglycerides, C12 to C24, even, saturated and unsaturated, bisulfited, sodium salt)
- Physical state: liquid
- Purity: 90%
- Impurities: 10% water content by Karl Fischer
- Lot/batch No.: LW03017
- Expiration date of the lot/batch: 23 February 2011
- Storage condition of test material: room temperature in the dark
- Other: opaque pale yellow color
- All other template details: Not reported

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories UK Limited, Hillcrest, Belton, Loughborough, UK
- Selection: eyes were examined for evidence of ocular irritation or defect, and corneal thickness was measured
- All other template details: not applicable

ENVIRONMENTAL CONDITIONS of Superfusion Chamber after Enucleation
- Temperature (°C): 32 +/- 1.5 degrees C
- Humidity (%): not applicable
- Flow rate: peristaltic pump was used to supply saline solution at a flow rate of 0.15-0.4 ml/min to irrigate the surface of the cornea
- Photoperiod (hrs dark / hrs light): not applicable

IN-LIFE DATES: not applicable

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 ml applied as evenly as possible to the surface of the cornea

VEHICLE: Not applicable

Duration of treatment / exposure:

10 seconds

Observation period (in vivo):

assessment of corneal cloudiness was made pre-enucleation, post equilibration and 60, 120, 180, and 240 minutes following treatment

Number of animals or in vitro replicates:

3 eyes treated with test material, two eyes untreated as controls

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): using a minimum of 20 ml of saline solution (approximately 32 degrees C)
- Time after start of exposure: 10 seconds

SCORING SYSTEM: numerical evaluation adopted from 'Advances in Modern Toxicology: Dermatoxicology, 4th Ed, (F Marzulli and H Maibach, eds) Hemisphere Publishing Corporation, Washington DC, 1991, pp 749-815.'

TOOL USED TO ASSESS SCORE: fluorescein and slit lamp biomicroscope, and thickness of cornea was measured using an ultrasonic pachymeter.

Results and discussion

In vivo

Results

Irritation parameter:

cornea opacity score

Remarks:

(for opacity)

Basis:

mean

Time point:

other: 240 minutes

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

other: all scores for corneal opacity for 3 test eyes and 2 control eyes were 0 at 60, 120, 180, 240 minutes post exposure

Irritant / corrosive response data:

All scores for corneal opacity for 3 test eyes and 2 control eyes were 0 at 60, 120, 180, 240 minutes post exposure

Other effects:

- No fluorescein uptake was noted in the test eyes or control eyes 240 minutes after treatment.
- Determination of corneal swelling: See Table 3

Any other information on results incl. tables

 

Table 3. Determination of Corneal Swelling (%)

Chamber Number Observation Period (minutes) Mean Corneal Thickness (µm) Cornea Swelling (%) Test Eyes 6A Post equilibration 402.4 N/A 60 Post treatment 448.0 11.3 120 Post treatment 464.4 15.4 180 Post treatment 458.2 13.9 240 Post treatment 448.0 11.3 7A Post equilibration 337.0 N/A 60 Post treatment 383.2 13.7 120 Post treatment 385.8 14.5 180 Post treatment 383.2 13.7 240 Post treatment 380.6 12.9 8A Post equilibration 349.4 N/A 60 Post treatment 404.8 15.9 120 Post treatment 419.8 20.1 180 Post treatment 428.4 22.6 240 Post treatment 423.6 21.2 Control Eyes 2A Post equilibration 379.6 N/A 60 Post treatment 398.6 5.0 120 Post treatment 391.2 3.1 180 Post treatment 398.8 5.1 240 Post treatment 408.4 7.6 4A Post equilibration 384.0 N/A 60 Post treatment 403.0 4.9 120 Post treatment 394.8 2.8 180 Post treatment 391.2 1.9 240 Post treatment 392.8 2.3

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: scoring from Hacket and McDonald 1991

Conclusions:

The test material was not considered to be an ocular irritant from application of the substance to the enucleated rabbit eye.

Executive summary:

Study report summary:

Introduction. A study was performed to assess the ocular irritancy potential of the test material in the rabbit following application onto the cornea of the enucleated eye. The results of the study are believed to be of value in predicting the ocular irritation potential of the test material in man.

 

Methods. 0.1 ml of the test material was applied onto the cornea of each of three enucleated eyes which had been maintained at a temperature of 32^oC±1.5^oC within the superfusion chamber. A further two enucleated eyes were treated, for control purposes, with saline solution (0.9% Sodium Chloride).

 

Results. Maximal ocular irritation observations recorded for the test eyes were as follows:

 

		Corneal Swelling (%)						Condition of Corneal Epithelium
Corneal Opacity	Fluorescein Uptake	Test Eyes			Control Eyes
Cldy x Area	Int x Area	60 mins	120 mins	240 mins	60 mins	120 mins	240 mins
0	0	13.6	16.7	15.2	5.0	2.9	4.9	normal

 

Conclusion. Following assessment of the data for all endpoints the test material was considered unlikely to have the potential to cause severe ocular irritancy in vivo.