Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: FHSA standard 16 CFR 1500.41
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Cashew (Anacardium occidentale) Nutshell Extract, Decarboxylated, Distilled
EC Number:
700-991-6
Cas Number:
8007-24-7
Molecular formula:
Cardanol (saturated side chain): Formula: C21 H36 O Cardanol (monoene): Formula: C21 H34 O Cardanol (diene): Formula: C21 H32 O Cardanol (triene): Formula: C21 H30 O
IUPAC Name:
Cashew (Anacardium occidentale) Nutshell Extract, Decarboxylated, Distilled
Details on test material:
- Name of test material (as cited in study report): Distilled CNSL
- Lot/batch No.: 1500-1, AF6155, 100-1, 1650-1

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Millbrook Breeding Labs
- Age at study initiation: Young adult
- Weight at study initiation: 2.1 - 2.7 kg
- Housing: 1/cage in suspended cages
- Diet (e.g. ad libitum): Fresh PMI Rabbit Chow
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week


ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
1 male/ 2 female
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: Plastic


REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle wiping

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
Sample 1500-1
Time point:
24 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
Sample 1500-1
Time point:
24 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
Sample 1500-1
Time point:
24 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
Sample 1500-1
Time point:
72 h
Score:
> 4
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
Sample 1500-1
Time point:
72 h
Score:
> 4
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
Sample 1500-1
Time point:
72 h
Score:
> 4
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
Sample 1500-1
Time point:
24 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
Sample 1500-1
Time point:
24 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
Sample 1500-1
Time point:
24 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
Sample 1500-1
Time point:
72 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
Sample 1500-1
Time point:
72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
Sample 1500-1
Time point:
72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
animal #2
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
animal #3
Time point:
48 h
Remarks on result:
not measured/tested

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Samples 1500-1 and AF6155 were irritating, however, samples 1600-1 and 1650-1 were not irritating.
Executive summary:

In a primary dermal irritation study, 3 young adult New Zealand white rabbits were dermally exposed to Cashew Nutshell Extract, Decarboxylated, Distilled (Distilled Grade) for 24 hours. Animals then were observed for 72 hours. Irritation was scored by the method of Draize.

 

In this study, Cashew Nutshell Extract, Decarboxylated, Distilled (Distilled Grade) is a dermal irritant.