Mixed esters of fatty acids C16 and C16-C18 unsatd. with adipic acid and pentaerythritol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March to April 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

(2002)

Principles of method if other than guideline:

This testing strategy comprised a stepwise approach including the evaluation of existing human and/or animal data showing effects on the eye or the skin, the performance of a SAR evaluation for eye and skin corrosion/irritation, measurement of pH value, the evaluation of data on systemic toxicity via the dermal route, the performance of a validated in vitro test for skin corrosion (Human 3D Epidermal Skin Model) and in vivo testing for skin irritation/corrosion in rabbits before in vivo testing for eye irritation/corrosion in rabbits.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Esterification products of fatty acids, C16 and C16-18 (even numbered, unsaturated) alkyl and adipic acid with pentaerythritol

EC Number:

923-900-3

Molecular formula:

Not applicable (UVCB substance)

IUPAC Name:

Esterification products of fatty acids, C16 and C16-18 (even numbered, unsaturated) alkyl and adipic acid with pentaerythritol

Test material form:

liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Strain: Crl:KBL(NZW)BR
- Sex: female
- Source: Charles River, 88353 Kißleg, Germany
- Age at study initiation: young adult animals
- Weight at study initiation: 3.1-3.5 kg
- Housing: individually in cage units Metall/Noryl by EBECO
- Diet and water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 50 +/- 25 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The other eye, which remained untreated, served as control.

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

The lids were gently held together for about one second in order to prevent loss of the test compound. The eye was rinsed approximately 24 hours following instillation.

Observation period (in vivo):

Animals were monitored after application until the changes had completely subsided, however for not more than 21 days after application.

Number of animals or in vitro replicates:

3

Details on study design:

0.1 ml of the pure liquid test substance was placed into the conjunctival sac of one eye of the first animal after having gently pulled the lower lid away from the eyeball. The lids were gently held together for about one second in order to prevent loss of the test compound.
Because of the fact that one hour after treatment a severe irritation was not observed, a further two rabbits were treated as described.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eye was rinsed approximately 24 hours following instillation.

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2, #3

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

animal: #1, #2, #3

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #1

Time point:

other: 24, 48, 72 hours

Score:

>= 0 - <= 1

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: mean score after 72 hours: 0.3

Results 4

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal: #2, #3

Time point:

other: 24, 48, 72 hours

Score:

>= 1 - <= 2

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: mean score after 72 hours: 1

Results 5

Irritation parameter:

chemosis score

Basis:

animal: #1, #2, #3

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Other effects:

The control eyes did not show any abnormal findings.
There were no systemic intolerance reactions.

Applicant's summary and conclusion

Executive summary:

An Acute Eye Irritation/ Corrosion Test according to OECD TG 405 was conducted with the test substance. Under the conditions of the test only slight effects were observed (3/3 rabbits showed conjunctivae score 1 or 2 after 24 hours, fully reversed at least after 72 hours). There were no systemic intolerance reactions.