Registration Dossier

Administrative data

Endpoint:
skin irritation / corrosion
Remarks:
in vitro
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Skin irritation was determined according to OECD Guideline 404 Acute Dermal Irritation / Corrosion.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
-Source: Millbrook Breeding Labs, Amherst, MA
-Sex: 2 males and 1 female
-Age: at least to 10 weeks olds (adult)
-Weight: 2.07 - 2.15 kilograms
-Housing: individually housed, cages: suspended stainless steel, bedding: hardwood chips.
- Diet: TEK 8630 Rabbit diet, Harlan Teklad, Madison, WI, ad libitum
- Water: tap water, ad libitum
- Acclimation period: minimum of 5 days under the same conditions as for the test.

ENVIRONMENTAL CONDITIONS
-Temperature: 68°F
-Humidity: 30-70%
-Air changes: 10 to 15 per hr
-Photoperiod: 12 hrs dark/light cycle, full spectrum fluorescent lights.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Remarks:
Sterile Water for Injection (WFI)
Controls:
other: The untreated areas of the skin of the animal as a control.
Amount / concentration applied:
The test substance (0.5g) was moistened with 0.1 mL of Sterile Water for Injection and applied directly to the skin of the rabbits (approximately on 6cm3). Each application area was covered with a gauze patch, which was held in place with non-irritant tape.
Duration of treatment / exposure:
Exposure period: 4 hours.
Observation period:
After the exposure period, animals were observed for signs of erythema and edema at 60 minutes, and then at 24, 48 and 72 hours after patch removal.
Number of animals:
3 animals (2 males and 1 female)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 60 minutes, 24, 48 and 72 hours
Score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 60 minutes, 24, 48 and 72 hours
Score:
0
Reversibility:
other: Not applicable
Irritant / corrosive response data:
The test substance was evaluated for its potential to produce primary dermal irritation or corrosion after a single topical 4 hour application to the skin of New Zealand White rabbits. No signs of erythema or edema wer noted at any observation period.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
The test substance is considered a non-irritant.