Fatty acids, C14-18 and C16-18-unsatd., maleated

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

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

Adequacy of study:

key study

Study period:

2012

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: well documented, according to GLP and OECD guideline, read across substance

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

1309959-24-7

Cas Number:

1309959-24-7

IUPAC Name:

1309959-24-7

Test material form:

liquid: viscous

Details on test material:

Liquid to high viscous / yellowish

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: 3 month
- Weight at study initiation: 2.61 - 3.02 kg
- Housing: single
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- For better handling the test item was heated 1 hour at 70 °C. The test item was administrated hand warm.

Duration of treatment / exposure:

About 24 hours after application of the test item the treated eye of the animal(s) was rinsed with 3 to 6 mL of hand warm tap water for 1 to 2 minutes using a syringe with a blunt probe.

Observation period (in vivo):

Approx. 1, 24, 48 and 72 h after application and then in weekly intervals up to day 21

Number of animals or in vitro replicates:

3 per sex per dose

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): 24h after installation

SCORING SYSTEM: draize system

TOOL USED TO ASSESS SCORE: hand-slit lamp and fluorescein
An additional eye examination was performed 24 h after application with the instillation of a fluorescein solution. Due to the result at the 24 hour reading further readings were performed with the aid of fluorescein until the 72 hour reading or the 7 day reading, respectively. Due to a negative result at the 72 hours reading or the 7 day reading, respectively (no corneal lesions detectable with fluorescein) no further readings were performed with the aid of fluorescein.
At the 24 hours reading reactions on cornea or iris were observed using a slit lamp and otoscope lamp. Because there were irritation reactions on cornea or iris, the progress was observed by slit lamp until reactions disappeared.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24-72h

Score:

1.4

Max. score:

4

Reversibility:

fully reversible within: 21d

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24 - 72h

Score:

0.9

Max. score:

2

Reversibility:

fully reversible within: 21 days

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24 - 72h

Score:

1.9

Max. score:

3

Reversibility:

fully reversible within: 21 days

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24 - 72h

Score:

2.3

Max. score:

4

Reversibility:

fully reversible within: 21 days

Irritant / corrosive response data:

The following test item-related clinical observations were recorded during the course of the study:

• Slight to moderate corneal opacity (grade 1 and 2)
• Moderate iritis (grade1)
• Slight to obvious conjunctival redness (grade 1 and 2)
• Slight to severe conjunctival chemosis (grade 1 to 4)
• Slight to severe discharge (grade 1 to 3)
• Additional findings like small retraction in the eyelid, contracted pupil and injected scleral vessels in a circumscribed or circular area were noted in the animals during observation period.

In two animals the ocular reactions were reversible within 14 days, in one animal within 21 days after application.

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Considering the described ocular reactions as well as the average score for irritation, the test item shows an eye irritating potential under the test conditions chosen.