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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Remarks:
Draize Methd, OECD TG 405
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: Draize Methd, OECD TG 405
Deviations:
no
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Tridecyl stearate
EC Number:
250-696-7
EC Name:
Tridecyl stearate
Cas Number:
31556-45-3
Molecular formula:
C31H62O2
IUPAC Name:
tridecyl stearate
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: lot P-055B5
-- Purity test date: 10% in corn oil

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: from a suitable licensed dealer
- Age at study initiation: 3 months
- Weight at study initiation: 2 Kg
- Housing:in galvanized or stainless steel cages
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):yes
- Acclimation period:at least 4 days prior to test intiation

ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled temperature (not precised)
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

Test system

Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
other: corn oil
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): single application of 0.5 mL
- Concentration (if solution): 10% in corn oil

NEGATIVE CONTROL
- Amount(s) applied (volume or weight):
- Concentration (if solution):

POSITIVE CONTROL
- Amount(s) applied (volume or weight): idem
- Concentration (if solution):idem
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: vertebral column
- % coverage: 2.5 cm2
- Type of wrap if used: surgical gauze pad and a Webril pad

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: 24 hours

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) at 24 hours and 72 hours

SCORING SYSTEM:
- Method of calculation: Draize skin scoring table

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
ca. 0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
ca. 0
Max. score:
1
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
ca. 0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
ca. 1
Max. score:
1
Reversibility:
not specified
Remarks on result:
probability of weak irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
ca. 0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
ca. 1
Max. score:
1
Reversibility:
not specified
Remarks on result:
probability of weak irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Score:
ca. 1
Max. score:
1
Reversibility:
not specified
Remarks on result:
probability of weak irritation
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0.63
Max. score:
0.63
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
ca. 1
Max. score:
1
Reversibility:
not specified
Remarks on result:
probability of weak irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
ca. 0
Max. score:
1
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Score:
ca. 1
Max. score:
1
Reversibility:
not specified
Remarks on result:
probability of weak irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Score:
ca. 0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
48 h
Score:
ca. 0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Not primary dermal irritants to rabbits under conditions of the test;
Tridecyl Stearate not irritant for skin