Registration Dossier

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

Constituent 1
Chemical structure
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 - C39H76O5
IUPAC Name:
(2R)-2,3-dihydroxypropyl octadecanoate 2,3-dihydroxypropyl hexadecanoate 2-hydroxy-3-(octadecanoyloxy)propyl octadecanoate 3-(hexadecanoyloxy)-2-hydroxypropyl octadecanoate
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

Resultsopen allclose all
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
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
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
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
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