Glycerides, C16-18 mono- and di-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

January 11th, 1999 - March 11th, 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP - guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Glycerides, C16-18 mono- and di-

EC Number:

286-490-9

EC Name:

Glycerides, C16-18 mono- and di-

Cas Number:

85251-77-0

Molecular formula:

C19H38O4; C21H42O4; C35H68O5; C39H76O5

IUPAC Name:

Glycerides, C16-18 mono- and di-

Details on test material:

- Name of test material (as cited in study report): Glyceryl Palmitostearate
- Physical state: white powder
- Analytical purity: considered as 100 % for the study
- Batch no.: 21150
- Storage conditions: at room temperature
- Expiry date: August 1st, 2000
- pH = 5.8
- Volumetric mass = 0.54 g/mL

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Elevage Scientifique des Dombes, Chalaronne, France
- Age at study initiation: about 3 months
- Weight at study initiation: 2.38 - 2.66 kg
- Housing: barrier protected unit, individually in stainless steel cages
- Diet: about 150 g/animal/day pelleted complete rabbit diet 112 C-10, Usine d'Alimentation Rationnelle, France.
- Water (e.g. ad libitum): softened and filtered mains drinking water
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 +/-3
- Humidity (%): > 45%
- Air changes (per hr): min. 12
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: January 25th, 1999 - January 28th, 1999

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye of the animals

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL (54 mg)
The test substance was crushed to a fine powder for eye treatment.

Duration of treatment / exposure:

single instillation

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no rinsing performed

SCORING SYSTEM:
Draize

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of all tested animals and mean of 3 readings at

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of all tested animals and mean of 3 readings at

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

3

Results 3

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of all tested animals and mean of 3 readings at

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

mean of 3 readings at

Time point:

other: 24, 48 and 72 h

Score:

0.7

Max. score:

2

Reversibility:

fully reversible within: 72 h

Results 5

Irritation parameter:

iris score

Basis:

animal: #2, #3, #4, #5, #6 and mean of 3 readings at

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

2

Other effects:

No mortality was observed during the study.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information to the rabbit eye Criteria used for interpretation of results: EU