Registration Dossier

Administrative data

Endpoint:
skin 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 404 (Acute Dermal 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:
Not available for UVCB
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

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Elevage Scientifique des Dombes, Chalaronne, France
- Age at study initiation: about 3 months
- Weight at study initiation: 2.23 - 2.40 kg
- Housing: barrier protected unit, individually in stainless steel cages
- Diet (e.g. ad libitum): 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

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
other: sterile Codex liquid paraffin
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g prepared as a paste with 0.21 g of sterile Codex liquid paraffin.
The paste was administered within 4 hours of preparation.

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.21 g sterile Codex liquid paraffin
- Lot/batch no. (if required): T0122B
- Expiry date: December 1st, 1999
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure:
- % coverage: 2.5 cm x 2.5 cm (about 6 cm2) gauze pad, perforated tape
- Type of wrap if used: crimped gauze bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm tap water was used to remove the excess of test article
- Time after start of exposure: 4 hourse

SCORING SYSTEM:
Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 6 tested animals and mean of 3 readings at
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal: #1, #2 and mean of 3 readings at
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean of 3 readings at
Time point:
other: 24, 48 and 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
erythema score
Basis:
animal #4
Remarks:
mean of 3 readings at
Time point:
other: 24, 48 and 72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal #5
Remarks:
mean of 3 readings at
Time point:
other: 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #6
Remarks:
mean of 3 readings at
Time point:
other: 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Other effects:
No mortality occured.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information to rabbit skin Criteria used for interpretation of results: EU