Reaction product of the esterification of diglycerol with decanoic acid (Old name: 1,2,3-Propanetriol, homopolymer, decanoate)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21st of July to 6th of August 2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

1,2,3-Propanetriol, homoplymer, decanoate

EC Number:

616-105-5

Cas Number:

74504-65-7

Molecular formula:

Main component: C16H32O6

IUPAC Name:

1,2,3-Propanetriol, homoplymer, decanoate

Test material form:

liquid

Details on test material:

Reaction mass of 3-(2,3-dihydroxypropoxy)-2-hydroxypropyl decanoate and 1-(2,3-dihydroxypropoxy)-3-hydroxypropan-2-yl decanoate

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source: From sponsor; CIBA Inc.
- Batch No.of test material:
512051
- Expiration date of the lot/batch: December 2008
- Purity test date: certificate of analysis dated June 16, 2008

- pH: 7.15
- Colour: colourless
- Form: liquid

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
Room temperature

The test item was considered as 100% for the study

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Remarks:

Albino females

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Elevage de Gérome (Quartier Labaste - F40260 Linxe)
- Sex: Females
- Age at study initiation: 11-14 weeks
- Weight at study initiation: 2.13-3.35 kg
- Housing: Each animal was kept in an individual box installed in conventional air conditioned animal husbanding
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22 °C
- Humidity (%): 43-63%
- Air changes (per hr): at least 10 per h; 20-24 volumes per hour measured on July 7, 2008
- Photoperiod (hrs dark / hrs light): 12 h/12 h

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The other untreated eye served as control

Amount / concentration applied:

0.1 ml

Duration of treatment / exposure:

One time

Observation period (in vivo):

14 days

Number of animals or in vitro replicates:

3

Details on study design:

SCORING SYSTEM:
The grades of ocular reaction (conjunctivae, cornea and iris) were recorded at each examination. Any lesions in the eye (e.g. pannus, staining) or adverse systemic effects were als reported.

EXAMINATIONS:
Ocular examinations were performed on both right and left eyes 1 hour, 24, 48 and 72 hours following treatment and then on further days until day 14.

TOOL USED TO ASSESS SCORE:
Fluorescein - After recording the observations at 24 hours, the eyes were further examined with the aid of fluorescein at 2%. Furthermore, examination of reactions was facilitated by use of an opthalamoscope (Heine Optotechnik, Gemany)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

1.3

Max. score:

2

Reversibility:

fully reversible within: between day 3 an day 9

Remarks on result:

positive indication of irritation

Results 2

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: day 9

Remarks on result:

positive indication of irritation

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0.7

Max. score:

1

Reversibility:

fully reversible within: 2 days

Remarks on result:

positive indication of irritation

Results 4

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

1.7

Max. score:

2

Reversibility:

fully reversible within: between day 9 and day 14

Remarks on result:

positive indication of irritation

Other effects:

A corneal neo-vascularisation at day 2 in one animal and at day 2 and 3 in one a second animal was noted

Any other information on results incl. tables

The ocular reactions observed during the study have been moderate and totally revesible in all three animals.

- at the conjunctivae level: a moderate redness, noted one hour after the test item instillation and totally reversible at day 9, associated with a moderate chemosis, noted one hour after the test item instillation and totally reversible between day 3 and 9;

- at the corneal level: a moderate opacity, registered 24 hours after the test item instillation and totally reversible between day 9 and day 14

- at the iris level: a congestion noted at day 1 and day 2 in one animal and at day 3 and 4 in a second animal

The mean scorings for the 24.48 and 72 readings for the indivudal animals were (chemosis -redness - iris - cornea)

Animal 1: 2.0 - 2.0 - 0.3 - 2.0

Animal 2: 1.0 - 2.0 - 0.0 - 2.0

Animal 3: 1.3 - 2.0 - 0.7 - 1.7

As all animals had a mean scoring > 1 for corneal opacity and a mean scoring of 2 for redness these two parameters according to the classification criteria waarant a classification as Eye Irrit 2 H319

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

The results obtained under these experimental conditions (OECD 405) enable to conlcude that the test item Dermosoft DGMC) is irritating to the eye according to the scales of interpretattion retained. In accordance with the Globally Harmonized System (COM(2007)355 final) the test item must be classified in category 2 “irritating to eyes”. The signal word “Warning” and hazard statement H319 “Causes serious eye irritation” are required.

Executive summary:

The eye irritating properties of test item Dermosoft DGMC was tested in accordance with OECD guideline 405. The test item was instilled as supplied into the eye of three New Zealand rabbits at the dose og 0.1 ml.

No clinical signs related to the test item was observed.

The ocular reactions observed during the study have been moderate and totally revesible in all three animals.

- at the conjunctivae level: a moderate redness, noted one hour after the test item instillation and totally reversible at day 9, associated with a moderate chemosis, noted one hour after the test item instillation and totally reversible between day 3 and 9;

- at the corneal level: a moderate opacity, registered 24 hours after the test item instillation and totally reversible between day 9 and day 14

- at the iris level: a congestion noted at day 1 and day 2 in one animal and at day 3 and 4 in a second animal

A corneal neo-vascularisation at day 2 in one animal and at day 2 and 3 in one a second animal was noted.

The mean scorings for the 24.48 and 72 readings for the indivudal animals were (chemosis -redness - iris - cornea)

Animal 1: 2.0 - 2.0 - 0.3 - 2.0

Animal 2: 1.0 - 2.0 - 0.0 - 2.0

Animal 3: 1.3 - 2.0 - 0.7 - 1.7

As all animals had a mean scoring>1 for corneal opacity and a mean scoring of 2 for redness these two parameters according to the classification criteria warrant a classification as Eye Irrit 2 H319