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
Study period:
The study was conducted between 20 October 2015 and 18 January 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor Lot/Batch number 1004R17501


STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature and humidity

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
- Preliminary purification step (if any):
- Final dilution of a dissolved solid, stock liquid or gel:
- Final preparation of a solid:

FORM AS APPLIED IN THE TEST (if different from that of starting material)

OTHER SPECIFICS:

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Covance Research Products Inc., Denver, PA, USA.
- Age at study initiation: ~27 weeks
- Weight at study initiation: 2.9 - 3.3 kg
- Housing: individually housed in suspended cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: >5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 20 October 2015 To: 23 October 2015

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g


VEHICLE
- Amount(s) applied (volume or weight with unit): 1.0
Duration of treatment / exposure:
72 h
Observation period:
72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: approx 6 sq cm
- % coverage: 100
- Type of wrap if used: non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): distilled water
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 1, 24, 48 and 72 h

SCORING SYSTEM:
- Method of calculation: Draize technique

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: ALL
Time point:
24 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal: All
Time point:
24 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal: all
Time point:
48 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal: all
Time point:
48 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal: all
Time point:
72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal: all
Time point:
72 h
Score:
ca. 0
Max. score:
0

Any other information on results incl. tables

Results Table:

 No. of animals  Dermal responses (time post exposure)  Erythema  Edema  Addiitonal dermal observations
             Four-hour exposure
 3  1 hr  Absent to very slight  Absent  NA
 3  24 hr  Absent  Absent  NA
 3  48 hr   Absent  Absent  NA 
 3  72 hr   Absent   Absent NA 
 Systemic Observations  No abnormal physical signs were observed
 Body weights  One animal gained bodyweight by study termination and two animals' weight remained the same
 Conclusion  RC 14156 is not a dermal irritant

NA = Not Applicable

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
RD 14156 is not a dermal irritant
Executive summary:

Objective:

To determine the irritant or corrosive effects, if any, of a test article when applied to the skin of a rabbit. This study was designed to comply with the standards set forth in the current OECD Guideline for Testing of Chemicals, Number 404 Acute Dermal Irritation/Corrosion.

Method Synopsis:

Since the test article was not expected to produce severe irritation or corrosion, three healthy New Zealand White rabbits (one male - two females) were dosed dermally with RD 14156. The test article (0.5 g) was applied dermally to one intact site per rabbit and wrapped with a semi-occlusive dressing. The test article was kept in contact with the skin for 4 hours at which time the wrappings were removed. Erythema and edema were scored at 1, 24, 48 and 72 hours. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction at these time periods. Animals were observed for mortality, toxicological and pharmacological effects at each dermal observation period. Body weights were recorded pretest and at termination.

Summary:

 No. of animals  Dermal responses (time post exposure)  Erythema  Edema  Addiitonal dermal observations
             Four-hour exposure
 3  1 hr  Absent to very slight  Absent  NA
 3  24 hr  Absent  Absent  NA
 3  48 hr   Absent  Absent  NA 
 3  72 hr   Absent   Absent NA 
 Systemic Observations  No abnormal physical signs were observed
 Body weights  One animal gained bodyweight by study termination and two animals' weight remained the same
 Conclusion  RC 14156 is not a dermal irritant

NA = Not Applicable