Fatty acids, C14-22, ethylene esters, 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:

guideline 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:

Rape oil, bisulfited, sodium salt

EC Number:

281-975-1

EC Name:

Rape oil, bisulfited, sodium salt

Cas Number:

84082-27-9

IUPAC Name:

-

Details on test material:

- Name of test material (as cited in study report): FLL sample 4
- Physical state: viscous liquid
- Lot/batch No.: 240210
- Expiration date of the lot/batch: not reported
- Storage condition of test material: room temperature in the dark
- Other: yellow/brown 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 determine the ocular irritancy potential. The endpoints related to the CLP Classification criteria are pressented in the results of in vivo study table.

TOOL USED TO ASSESS SCORE: ophthalmoscope

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 3

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

mean

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 48h

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Irritant / corrosive response data:

See Table 1.

Other effects:

Body weight changes after 3 days: +0.05 kg

Any other information on results incl. tables

Table 1. Individual Scores and Individual Total Scores for Ocular Irritation Rabbit number and sex 69220 Male 69238 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 0 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 0 0 12 6 0 0 Total Score 12 6 0 0 12 6 0 0

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

CLP Implementation.

Conclusions:

A single application of the test material to the non-irrigated eye of two rabbits produced moderate conjuctival irritation. Both treated eyes appeared normal at the 48 -Hour observation.

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. Both treated eyes appeared normal at the 48 -Hour observation.

 

Conclusion. The test material produced a maximum group mean score of 12.0 and was classified as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. However, based on the CLP criteria, the substance is not classified for eye irritation.