Oils, fish, oxidized, bisulfited, sodium salts

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 17-27 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study (OECD 405, EU B.5)

Justification for data waiving:

other:

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

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Oils, fish, oxidized, bisulfited, sodium salts

EC Number:

307-037-4

EC Name:

Oils, fish, oxidized, bisulfited, sodium salts

Cas Number:

97488-98-7

Molecular formula:

Not applicable

IUPAC Name:

not available

Details on test material:

- Name of test material (as cited in study report): FLL sample 3
- Chemical name: Oils, fish, oxidized, bisulfited, sodium salts (triglycerides, C12 to C24, even, saturated and unsaturated, bisulfited, sodium salt)
- Physical state: viscous liquid
- Purity: 90%
- Impurities: 10% water content by Karl Fischer
- Lot/batch No.: LS06921
- Expiration date of the lot/batch: 13 October 2010
- Storage condition of test material: room temperature in the dark
- Other: amber 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
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.40 or2.42 kg
- Housing: individually housed in suspended cages
- Diet (e.g. ad libitum): ad libitum to 2030 Teklad global rabbit diet
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 degrees C
- Humidity (%): 30-70%
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12 / 12 dark-light

IN-LIFE DATES: not reported

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 ml

VEHICLE: Not applicable

Duration of treatment / exposure:

Test material was applied to eye, and the eyelids were held together for about 1 second and then released. Eyes were not rinsed after exposure.

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

2

Details on study design:

REMOVAL OF TEST SUBSTANCE: Not applicable

SCORING SYSTEM: initial pain reaction from 6-point scale, Draize scale for scoring ocular irritation was used during the observation period. After scores were assigned, a modified version of Kay and Calandra (1962) was used to classify the ocular irritancy potential.

TOOL USED TO ASSESS SCORE: ophthalmoscope

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 72 hours

Score:

0

Max. score:

12

Reversibility:

not specified

Remarks on result:

other: Both test animals had scores of 12 at 1 hour, which had diminished to 6 at 24 hours. Both had a score of 0 at 72 hours.

Irritant / corrosive response data:

See Table 1.

Other effects:

Body weight changes after 3 days: male 1 = -0.12 kg, male 2 = 0.02 kg

Any other information on results incl. tables

Table 1. Individual Scores and Individual Total Scores for Ocular Irritation Rabbit number and sex 69221 Male 69239 Male Time after treatment 1 hour 24 hours 48 hours 72 hours 1 hour 24 hours 48 hours 72 hours Cornea  E = Degree of opacity 0 0 0 0 0 0 0 0  F = Area of Cornea involved 0 0 0 0 0 0 0 0  Score (E x F) x 5 0 0 0 0 0 0 0 0 Iris  D 0 0 0 0 0 0 0 0  Score (D x 5) 0 0 0 0 0 0 0 0 Conjunctivae  A = Redness 2 1 1 0 2 1 0 0  B = Chemosis 2 1 0 0 2 1 0 0  C = Discharge 2 1 0 0 2 1 0 0  Score (A + B + C) x 2 12 6 2 0 12 6 0 0 Total Score 12 6 2 0 12 6 0 0

 

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: modified Kay and Calandra 1962

Conclusions:

The test substance was determined to be a mild irritant (Class 4 on a 1 - 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.

Executive summary:

Study report summary:

Introduction. The study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method was designed to meet the requirements of the following:

-      OECD guidelines for the testing of chemicals No. 405 “Acute Eye Irritation/Corrosion” (adopted 24 April 2002)

-      Method B.5 Acute Toxicity (Eye Irritation) of Commission Regulation (EC) No. 440/2008

 

Result. A single application of the test material to the non-irrigated eye of two rabbits produced moderate conjuctival irritation. One treated eye appeared normal at the 48-Hour observation and the other treated eye appeared normal at the 72-Hour observation.

 

Conclusion. The test material produced a maximum group mean score of 12.0 and was classified as a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.