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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1994
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Federal Hazardous Substauces Act, Consumer Product Safety Commission, 16 CFR, Section 1500.41
Deviations:
not specified
Principles of method if other than guideline:
- Principle of test: Six normal, healthy, albino rabbits were used for this assay.The test material was applied as received.0.5 gm of the test material was applied to the intact site and 0.5 mg to the abraded site of each of the six test animals. The application
sites were covered with 1" x 2" Webril patches and sealed with Dermaclear Transparent Tape. The entire treated area was then wrapped with a sheet of polyethylene and taped so that evaporation was retarded and the test material remained in direct contact with the application sites.
The wrapping was removed at the end of the 24 hour contact period and the application sites wiped of excessive material. The treated areas were then examined for signs of erythema and or edema. Readings were again made at 72 hours post application.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Jojoba, ext., hydrogenated
EC Number:
296-292-4
EC Name:
Jojoba, ext., hydrogenated
Cas Number:
92457-12-0
Molecular formula:
No molecular formula is available since it is a UVCB substance
IUPAC Name:
Jojoba (Simmondsia Chinensis) Seed Oil Hydrogenated
Test material form:
solid: flakes

Test animals

Species:
rabbit
Strain:
other: Albino

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: abraded and clipped
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mg of test material
Duration of treatment / exposure:
24 h
Observation period:
72 h
Number of animals:
6
Details on study design:
Six normal, healthy, albino rabbits were used for this assay. On the day prior to the test procedure 10% of the total body area of each animal was carefully clipped free of all hair using small animal clippers. Animals with unusual skin characteristics were not used.
Two sites on each clipped back were employed in the assay. One site was left intact and the second site received several minor abrasions that were sufficiently deep to penetrate the stratum corneum but not disturb the derma so that bleeding did not occur.
The test material was applied as received. 0.5 gm of the test material was applied to the intact site and 0.5 mg to the abraded site of each of the six test animals.
The application sites were covered with 1" x 2" Webril patches and sealed with Dermaclear Transparent Tape. The entire treated area was then wrapped with a sheet of polyethylene and taped so that evaporation was retarded and the test material remained in direct contact with the application sites.
The wrapping was removed at the end of the 24 hour contact period and the application sites wiped of excessive material. The treated areas were then examined for signs of erythema and or edema.
Readings were again made at 72 hours post application.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: Readings only at 24/72h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
8
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
8
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
8
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
8
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
8
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
8
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material as submitted, when tested as described, would not be classified as a skin irritant.