Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study is rated a "1" because it applied GLP, used appropriate testing procedures, and followed an accepted test guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
IUCLID4 Test substance: as prescribed by 1.1 - 1.4

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: HRP Inc., Denver, PA
- Age at study initiation: 13-14 weeks
- Weight at study initiation: 2.17-2.42 kg
- Housing: single housed
- Diet: certified Rabbit Diet 5322. Animals received new feed each day.
- Water: ad libitum
- Acclimation period: 10 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 65-70
- Humidity (%): 40-60
- Photoperiod (hrs dark / hrs light): 12 hours light/ 12 hours dark


IN-LIFE DATES: From: 1995-12-21 To:1995-12-26

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: closely clipped with electric clipper
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml
Duration of treatment / exposure:
4 hours
Observation period:
Dermal responses were evaluated 60 minutes, 24, 48, and 72 hours following patch removal.
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 1 inch x 1 inch

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Test site was wiped using peanut oil and paper towels to remove any residual material without altering the existing response or integrity of the epidermis.
- Time after start of exposure: 4 hours


SCORING SYSTEM:
All scoring was made according to the modified Draize method of scoring (Draize, 1959).
Mean erythema and edema scores were calculated (Snedecor and Cochran, 1989).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24-72 hour
Score:
0
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 - 72 hours
Score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 - 72 hours
Score:
0
Reversibility:
fully reversible
Irritant / corrosive response data:
Topical application of the test substance elicited very slight erythema in one animal at the 60 minute time point. All animals were free of erythema, edema, or other supplemental dermal findings during the remainder of the study. Consequently, the study was terminated following the 72 hour observation period.
Other effects:
Clinical signs were not observed in any animal during the test period. All animals survived to study termination.

Any other information on results incl. tables

The mean erythema and edema scores for each time interval were as follows:

ERYTHEMA:

60 min: 0.17

24 hr: 0.00

48 hr: 0.00

72 hr: 0.00

EDEMA:

60 min: 0.00

24 hr: 0.00

48 hr: 0.00

72 hr: 0.00

Mean erythema and edema for 24, 48, and 72 hours were as follows:

Erythema : 0.00

Edema: 0.00

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
Based on the findings of this study and a primary irritation index of 0.00, the test substance is considered a non-irritant to rabbit skin.
Executive summary:

Six male rabbits were exposed to 0.5 ml of the test material during 4 hours, the patch held in contact with the skin by means of a semi-occlusive dressing. Only very slight erythema in one animal was noted at 60 minutes after removal of the patch, no other signs of irritation at 24, 48 and 72 hours were observed. This study was performed according to GLP procedures.