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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:
No data
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
Federal Hazardous Substance Act Regulations - Consumer Product Safety Commission, 16 CFR, Part 1500, Chapter II, Subpart C, Section 1500.41, 1988.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS

- Source: Eastern Rabbit Breeding Industry, Taunton, MA

- Age at study initiation: 11 weeks

- Weight at study initiation: 2-3kg

- Housing: Individually housed in suspended stainless steel cages, with hardwood chips as non-contact bedding under the cages.

- Diet: commercial rabbit ration, ad libitum

- Water: municipal water, ad libitum

- Acclimation period: upon receipt, animals were placed in quarantine for 3 days.


ENVIRONMENTAL CONDITIONS

- Temperature (°F): 68 +/- 3

- Humidity (%): 30-70

- Air changes (per hr): minimum 10-13

- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: shaved and abraded sites tested independently
Vehicle:
unchanged (no vehicle)
Controls:
other: Each animal served as its own control.
Amount / concentration applied:
TEST MATERIAL

- Concentration (if solution): Undiluted

Duration of treatment / exposure:
24 hour(s)
Observation period:
The animals were observed for signs of erythema and edema at 24 and 72 hours post application of the test substance.
Number of animals:
3M, 3F
Details on study design:
TEST SITE

- Area of exposure: dorsal skin

- Type of wrap if used: gauze patch, which was held in place with Vetrap bandaging. the patches were applied to one intact site and one abraded site per animal.


REMOVAL OF TEST SUBSTANCE

- Washing (if done): The skin was wiped and rinsed with USP water for injection following the exposure period to remove remaining test article.

- Time after start of exposure: 24 hours


SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24/72h
Score:
0
Max. score:
0
Reversibility:
other: no effects
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
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:
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:
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:
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:
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:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No overt signs of toxicity were evident in any of the animals during the course of the study. No signs of erythema or edema formation were evident on the test (or control) sites of any animal at any of the observation periods, whether the skin was abraded or intact.
Other effects:
All of the test animals exhibited a gain in body weight during the study.

Any other information on results incl. tables

The test article is considered non-irritating to the skin of the test animals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material was determined to not be irritating to rabbit skin in a reliable study conducted according to an appropriate test protocol.